Aflibercept
Protein / enzyme biologic targets VEGFA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 32 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed central retinal vein occlusion with macular edema 2 milestones | |||||
| Filed | China (NMPA) | — | central retinal vein occlusion with macular edema | 2026-08-13 | “the National Medical Products Administration (NMPA) in China has accepted for review the application for aflibercept 8 mg” bayer.com ↗ |
| Filed | Japan (PMDA) | — | central retinal vein occlusion with macular edema | 2025-05-09 | “Bayer has submitted an application to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval of aflibercept 8 mg” bayer.com ↗ |
| Filed diabetic macular edema 6 milestones | |||||
| Rejected (CRL) | US (FDA) | EYLEA HD | diabetic macular edema | 2025-04-18 | “the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of...” regeneron.com ↗ “The FDA issued a Complete Response Letter (CRL) for the EYLEA HD pre-filled syringe on April 23, 2025.” regeneron.com ↗ |
| Rejected (CRL) | US (FDA) | — | diabetic macular edema | 2023-06-27 | “In June 2023, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8 mg” regeneron.com ↗ “the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for aflibercept 8 mg” regeneron.com ↗ |
| Filed | Japan (PMDA) | — | diabetic macular edema | 2023-03-01 | “Bayer has submitted an application to the Japanese Ministry of Health, Labor, and Welfare (MHLW) seeking approval of aflibercept 8 mg” bayer.com ↗ “application for regulatory authorization of aflibercept 8 mg in the EU, Japan, and other markets for the treatment of nAMD and DME” bayer.com ↗ “A regulatory application has also been submitted for the treatment of wet AMD and DME in the European Union (EU) and Japan.” regeneron.com ↗ “Regulatory filings for aflibercept 8 mg are under review in Europe and Japan.” regeneron.com ↗ |
| Filed | US (FDA) | — | diabetic macular edema | 2023-02-23 | “FDA has accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg” regeneron.com ↗ |
| Filed | EU (EMA) | Eylea 8 mg | diabetic macular edema | 2023-02-06 | “Bayer has submitted an application for market authorization to the European Medicines Agency (EMA) for aflibercept 8 mg in two major retinal eye diseases” bayer.com ↗ “application for regulatory authorization of aflibercept 8 mg in the EU, Japan, and other markets for the treatment of nAMD and DME” bayer.com ↗ “A regulatory application has also been submitted for the treatment of wet AMD and DME in the European Union (EU) and Japan.” regeneron.com ↗ “In February 2025, Bayer submitted an application to EMA to expand treatment intervals to up to 6 months with Eylea 8 mg” bayer.com ↗ “In February 2025, Bayer submitted an application to EMA to expand treatment intervals to up to 6 months with Eylea 8 mg” bayer.com ↗ “Regulatory filings for aflibercept 8 mg are under review in Europe and Japan.” regeneron.com ↗ |
| Filed | US (FDA) | EYLEA | diabetic macular edema | 2018-09-13 | “FDA has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy (DR)” regeneron.com ↗ “In February 2023, the U.S. Food and Drug Administration (FDA) accepted for Priority Review the Biologics License Application (BLA) for aflibercept 8 mg” regeneron.com ↗ “Aflibercept 8 mg BLA for neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME) accepted for FDA priority review” regeneron.com ↗ “The Company recently submitted a supplemental Biologics License Application (sBLA) for EYLEA for the treatment of diabetic retinopathy.” regeneron.com ↗ “In April 2019, the Company resubmitted a supplemental Biologics License Application (sBLA) for EYLEA in a pre-filled syringe.” regeneron.com ↗ “In the second quarter of 2018, the Company submitted an sBLA for EYLEA in a pre-filled syringe.” regeneron.com ↗ |
| Filed diabetic retinopathy 1 milestone | |||||
| Filed | US (FDA) | EYLEA | diabetic retinopathy | 2022-06-29 | “The FDA accepted for review the sBLA for EYLEA for an every-16-weeks dosing regimen in patients with diabetic retinopathy (DR).” regeneron.com ↗ “FDA has accepted for review the EYLEA® (aflibercept) Injection supplemental Biologics License Application (sBLA)” regeneron.com ↗ |
| Filed retinal vein occlusion 2 milestones | |||||
| Filed | US (FDA) | EYLEA HD | retinal vein occlusion | 2025-04-17 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD®” regeneron.com ↗ |
| Filed | EU (EMA) | Eylea 8 mg | retinal vein occlusion | 2025-04-08 | “Bayer has submitted an application to the European Medicines Agency (EMA) seeking approval of aflibercept 8 mg” bayer.com ↗ |
| Filed retinopathy of prematurity 1 milestone | |||||
| Filed | US (FDA) | EYLEA | retinopathy of prematurity | 2022-10-12 | “FDA has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in...” regeneron.com ↗ “The U.S. Food and Drug Administration (FDA) accepted for priority review the supplemental BLA (sBLA) for EYLEA to treat retinopathy of prematurity (ROP)” regeneron.com ↗ |
| Filed severe nonproliferative diabetic retinopathy 1 milestone | |||||
| Filed | US (FDA) | EYLEA | severe nonproliferative diabetic retinopathy | 2022-05-04 | “A supplemental Biologics License Application (sBLA) for EYLEA for an every-16-weeks dosing regimen in patients with non-proliferative diabetic retinopathy (NPDR) was submitted.” regeneron.com ↗ |
| Filed wet macular degeneration 3 milestones | |||||
| Filed | China (NMPA) | — | wet macular degeneration | 2024-01-24 | “China’s National Medical Products Administration (NMPA) accepted the submission of an application for regulatory approval of aflibercept 8 mg” bayer.com ↗ |
| Rejected (CRL) | US (FDA) | EYLEA | wet macular degeneration | 2018-08-13 | “the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept)...” regeneron.com ↗ |
| Filed | US (FDA) | EYLEA® | wet macular degeneration | 2017-12-11 | “The supplemental Biologics License Application (sBLA) for a 12-week dosing interval of EYLEA in patients with neovascular age-related macular degeneration (wet AMD) was filed...” regeneron.com ↗ “FDA has accepted for review the Company's supplemental Biologics License Application (sBLA) for a 12-week dosing interval of EYLEA® (aflibercept)” regeneron.com ↗ |
| Approved Indication not stated 9 milestones | |||||
| Label expansions (2) | US (FDA) | EYLEA HD | — | 2025-11-19 – 2026-04-02 | fda.gov ↗ |
| Filed | US (FDA) | EYLEA HD | — | 2025-01-13 | “the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept)” alvotech.com ↗ “The Company filed an application with the FDA for use of the EYLEA HD pre-filled syringe (PFS)” regeneron.com ↗ |
| Filed | EU (EMA) | — | — | 2024-08-15 | “today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept).” alvotech.com ↗ |
| Filed | EU (EMA) | — | neovascular age-related macular degeneration, other severe retinal diseases | 2023-11-27 | “the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea® 1 (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency” formycon.com ↗ |
| Filed | US (FDA) | — | severe retinal diseases | 2023-06-29 | “BLA for FYB203, a biosimilar candidate for Eylea® 1 (Active ingredient: Aflibercept) has been submitted” formycon.com ↗ |
| Label expansions (7) | US (FDA) | EYLEA | — | 2012-09-21 – 2023-02-08 | fda.gov ↗ |
| Label expansion | US (FDA) | ZALTRAP | — | 2015-09-17 | fda.gov ↗ |
| Approved | EU (EMA) | Eylea | — | 2012-11-21 | europa.eu ↗ |
| Approved | US (FDA) | EYLEA | — | 2011-11-18 | fda.gov ↗ |
Trials 272 · started per year
News releases announcing trial results or a regulatory action · 128
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | EyePoint Pharmaceuticals, Inc. | Results EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU™ 2.7mg in Wet AMD eyepoint.bio ↗
DURAVYU was non-inferior to on-label aflibercept control (nominal p-value = 0.0096) in an ad hoc analysis excluding a 4% asymmetric cohort (9 of 211 patients) who experienced vision loss (≥ 15 letters) unrelated to wet AMD |
| 2026-08-13 | Bayer | Regulatory Aflibercept 8 mg application for macular edema following retinal vein occlusion accepted for review in China bayer.com ↗
China’s National Medical Products Administration (NMPA) has accepted for review the application for aflibercept 8 mg (114.3 mg/ml solution for injection) for the treatment of macular edema following retinal vein occlusion (RVO) |
| 2026-04-13 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Announces Additional Positive Week 52 Data from Landmark SOL-1 Phase 3 Trial of AXPAXLI™ in Wet AMD ocutx.com ↗
The median time to ≥30 uM Central Subfield Thickness (CSFT) increase from Week 8 was 39 weeks in the AXPAXLI group and 16 weeks in the aflibercept (2 mg) group, a 23-week difference. |
| 2026-04-02 | Regeneron Pharmaceuticals | Regulatory EYLEA HD® (aflibercept) Approved by FDA as First and Only Injectable Anti-VEGF with Dosing Intervals Up to 5 Months for Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of dosing intervals for EYLEA HD® (aflibercept) up to every 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) following one year of successful response based on visual and anatomic outcomes. |
| 2026-03-23 | Bayer | Regulatory Eylea™ 8 mg approved for third retinal indication in Japan bayer.com ↗ |
| 2026-02-17 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Reports Positive Results from Landmark SOL-1 Phase 3 Superiority Trial in Wet AMD ocutx.com ↗
Superiority primary endpoint met with 74.1% of subjects in the AXPAXLI™ arm maintaining vision at Week 36, a 17.5% risk difference (p=0.0006), compared to aflibercept (2 mg) arm |
| 2026-01-16 | Bayer | Regulatory Eylea™ 8 mg approved in the EU for third retinal indication bayer.com ↗ |
| 2025-12-12 | Bayer | Regulatory Aflibercept 8 mg recommended for EU approval for third retinal indication bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended aflibercept 8 mg (114.3 mg/ml solution for injection) for marketing authorization in the European Union (EU) for the treatment of patients with visual impairment due to macular edema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion. |
| 2025-12-05 | Santen Gmbh | Regulatory Aflibercept intraocular injection kit 40 mg/mL Bayer Listed in NHI Drug Price List santen.com ↗
Aflibercept intraocular injection kit 40 mg/mL Bayer*, for which Bayer Life Science has received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare (MHLW) has been listed in the National Health Insurance (NHI) Drug Price List. |
| 2025-11-19 | Regeneron Pharmaceuticals | Regulatory EYLEA HD® (aflibercept) Injection 8 mg Approved by FDA for the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing Across Approved Indications regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD® (aflibercept) Injection 8 mg for the treatment of patients with macular edema following retinal vein occlusion (RVO) with up to every 8-week dosing after an initial monthly dosing period. |
| 2025-10-28 | Regeneron Pharmaceuticals | Regulatory Regeneron Reports Third Quarter 2025 Financial and Operating Results regeneron.com ↗
Yesterday, the FDA issued a Complete Response Letter (CRL) for the pre-filled syringe supplemental BLA (sBLA). |
| 2025-09-19 | Alvotech Swiss AG | Regulatory Alvotech Announces Marketing Approval in Japan of Three New Biosimilars alvotech.com ↗
AVT06, approved in Japan as AFLIBERCEPT BS 40 mg/mL solution in PFS for IVT injection and 40 mg/mL vial kit for IVT injection, is a biosimilar to Eylea® (aflibercept). |
| 2025-08-21 | Alvotech Swiss AG | Regulatory Advanz Pharma and Alvotech receive European approval for Mynzepli®, Biosimilar to Eylea® alvotech.com ↗ |
| 2025-08-20 | Regeneron Pharmaceuticals | Regulatory EYLEA HD® (aflibercept) Injection 8 mg Applications for Expanded U.S. Label and Prefilled Syringe Receive FDA Review Period Extension regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended the target action dates to the fourth quarter of 2025 for two EYLEA HD® (aflibercept) Injection 8 mg regulatory submissions. |
| 2025-06-27 | Bayer | Regulatory Eylea™ 8 mg with extended 6-month treatment interval approved in the EU bayer.com ↗
The European Commission (EC) has granted a label extension in the European Union (EU) for Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) with extended treatment intervals of up to 6 months for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). |
| 2025-05-23 | Bayer | Regulatory Eylea™ 8 mg with extended 6-month treatment interval recommended for approval in EU bayer.com ↗
Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label extension for Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection). |
| 2025-05-22 | Bayer | Regulatory Eylea™ 8 mg approved in China for wet age-related macular degeneration bayer.com ↗
The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved Eylea™ 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) in China. |
| 2025-05-09 | Bayer | Regulatory Aflibercept 8 mg to treat macular edema following retinal vein occlusion submitted for approval in Japan bayer.com ↗ |
| 2025-04-28 | Regeneron Pharmaceuticals | Results EYLEA HD® (aflibercept) Injection 8 mg Presentations at ARVO Reinforce Continued Safety and Efficacy and Highlight Early Real-World Outcomes for Patients with Serious Retinal Disease regeneron.com ↗
This includes new analyses examining the initial real-world experiences of nearly 40,000 patients treated with EYLEA HD showing, in everyday clinical practice, a positive impact through improved vision and longer dosing intervals for patients. |
| 2025-04-18 | Regeneron Pharmaceuticals | Regulatory Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application regeneron.com ↗
The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label). |
| 2025-04-17 | Regeneron Pharmaceuticals | Regulatory EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA HD® (aflibercept) Injection 8 mg. |
| 2025-04-08 | Bayer | Regulatory Bayer files for approval of aflibercept 8 mg for treatment of retinal vein occlusion in EU bayer.com ↗ |
| 2025-02-25 | Formycon AG | Regulatory Formycon receives regulatory approval in the UK for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand name AHZANTIVE® formycon.com ↗
Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (Klinge) jointly announce that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB203 (aflibercept), a biosimilar to Eylea ® 1 , under the brand name AHZANTIVE ® 2 . |
| 2025-02-18 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept) alvotech.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06 |
| 2025-02-10 | Bayer | Regulatory Bayer files for approval of extended 6-month treatment interval for Eylea™ 8 mg in the EU bayer.com ↗ |
| 2025-02-08 | Bayer | Results Long-term efficacy and safety of Eylea™ 8 mg with extended dosing intervals in wet age-related macular degeneration confirmed at three years bayer.com ↗
The data confirm the high durability of Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) as well as its long-term efficacy and safety at the end of three years. |
| 2025-02-08 | Regeneron Pharmaceuticals | Results Three-Year Results for EYLEA HD® (aflibercept) Injection 8 mg in Patients with Wet Age-related Macular Degeneration Demonstrate Continued Durable Vision Gains and Anatomic Improvements with Extended Dosing Intervals regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive three-year (156-week) results for EYLEA HD® (aflibercept) Injection 8 mg in patients with wet age-related macular degeneration (wAMD) from an extension study of the Phase 3 PULSAR trial. |
| 2025-02-08 | Regeneron Pharmaceuticals | Results EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting regeneron.com ↗ |
| 2025-02-04 | Regeneron Pharmaceuticals | Results Regeneron Reports Fourth Quarter and Full Year 2024 Financial and Operating Results; Initiates Quarterly Dividend and Increases Total Share Repurchase Capacity to ~$4.5 Billion regeneron.com ↗
The Company announced that the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD for the treatment of patients with macular edema following RVO, including those with central, branch, and hemiretinal vein occlusions. |
| 2025-01-20 | Formycon AG | Regulatory Formycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama® formycon.com ↗
Formycon AG (FSE: FYB, Prime Standard, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) today jointly announce that the European Commission has granted central marketing authorization for FYB203 (Aflibercept), a biosimilar to Eylea ® 1 , under the brand names AHZANTIVE ® 2 and Baiama ® 3 . |
| 2025-01-14 | Bayer | Results Bayer’s Pharma Growth Strategy Progressing Well as Pipeline Advances bayer.com ↗
In the global Phase III QUASAR study evaluating the efficacy and safety of aflibercept 8 mg in patients with macular edema following retinal vein occlusion (RVO), including central, branch, hemi-retinal vein occlusion, the primary endpoint at week 36 was met. |
| 2024-12-17 | Bayer | Results Aflibercept 8 mg met primary endpoint in phase III study and demonstrates vision gains with extended treatment intervals in retinal vein occlusion bayer.com ↗
Bayer announced today positive topline results from the global phase III QUASAR study evaluating the efficacy and safety of aflibercept 8 mg in patients with macular edema following retinal vein occlusion (RVO), including central, branch and hemiretinal vein occlusion. |
| 2024-12-17 | Regeneron Pharmaceuticals | Results EYLEA HD® (aflibercept) Injection 8 mg Phase 3 Trial Meets Primary Endpoint Showing Improved Vision with Extended Dosing Intervals in Patients with Macular Edema following Retinal Vein Occlusion regeneron.com ↗
In the trial, patients treated with EYLEA HD every 8 weeks (after initial monthly doses) experienced non-inferior vision gains compared to those treated with the approved monthly dosing regimen of EYLEA® (aflibercept) Injection 2 mg, the current standard of care. |
| 2024-11-18 | Formycon AG | Regulatory Formycon receives positive CHMP opinion for FYB203 (aflibercept), a biosimilar candidate to Eylea® under the tradenames AHZANTIVE® and Baiama® formycon.com ↗
Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends approval of FYB203 for the treatment of Neovascular Age-Related Macular Degeneration (nAMD), along with several other serious retinal diseases |
| 2024-11-15 | Formycon AG | Regulatory Aflibercept-Biosimilar FYB203 / AHZANTIVE®/ Baiama® receives positive CHMP Opinion from EMA formycon.com ↗
Formycon (FSE: FYB, “Formycon“) announces that the European Medicines Agency (EMA) published today that the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for market approval for FYB203 / AHZANTIVE ®1 / Baiama ®2 , a biosimilar candidate to Eylea ®3 (Aflibercept). |
| 2024-10-31 | Regeneron Pharmaceuticals | Results Regeneron Reports Third Quarter 2024 Financial and Operating Results regeneron.com ↗
The Company announced positive three-year (156-week) data from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). |
| 2024-10-19 | Bayer | Results Long-term efficacy and safety profile of Eylea™ 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years bayer.com ↗
Patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements at the end of three years, with the vast majority of patients on extended dosing intervals of ≥ 3 months. |
| 2024-10-18 | Regeneron Pharmaceuticals | Results Three-year Results for EYLEA HD® (aflibercept) Injection 8 mg Demonstrate Continued Durable Vision Gains and Anatomic Improvements with Extended Dosing Intervals in Patients with Diabetic Macular Edema regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive three-year (156-week) data for EYLEA HD® (aflibercept) Injection 8 mg from an extension study of the Phase 3 PHOTON trial in patients with diabetic macular edema (DME). |
| 2024-09-11 | Regeneron Pharmaceuticals | Results EYLEA HD® (aflibercept) Injection 8 mg Data at EURETINA Reinforce Long-term Durability, Sustained Fluid Control and Safety Profile regeneron.com ↗ |
| 2024-09-09 | Bayer | Regulatory Eylea™ 8 mg pre-filled syringe approved in the EU bayer.com ↗
The European Medicines Agency (EMA) has approved the pre-filled syringe for the administration of Eylea™ 8 mg (114.3 mg/ml solution for injection) in the European Union. |
| 2024-08-15 | Alvotech Swiss AG | Regulatory European Medicines Agency Confirms Acceptance of Marketing Application for AVT06, a Proposed Biosimilar to Eylea® (aflibercept) alvotech.com ↗
today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept). |
| 2024-08-12 | Sandoz | Regulatory Sandoz receives FDA approval for Enzeevu™ (aflibercept-abzv), further strengthening US biosimilar position sandoz.com ↗ |
| 2024-07-01 | Formycon AG | Regulatory Formycon receives FDA approval for FYB203/AHZANTIVE®1) (aflibercept-mrbb), a biosimilar to Eylea®2) formycon.com ↗
Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, “Formycon”) and its licensing partner Klinge Biopharma GmbH (“Klinge”) jointly announce that the U.S. Food and Drug Administration (“FDA”) approved FYB203/AHZANTIVE ® (aflibercept-mrbb), a biosimilar to Eylea ® , on June 28, 2024. |
| 2024-06-28 | Formycon AG | Regulatory FDA grants approval for Eylea®1) biosimilar FYB203/AHZANTIVE®2) (aflibercept-mrbb) formycon.com ↗ |
| 2024-04-29 | Regeneron Pharmaceuticals | Results EYLEA® HD (aflibercept) Injection 8 mg Presentations at ARVO Reinforce Sustained and Clinically Meaningful Outcomes in Serious Retinal Diseases regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the presentation of positive long-term results and subgroup analyses from the pivotal clinical program of EYLEA® HD (aflibercept) Injection 8 mg. |
| 2024-03-08 | Bayer | Results Aflibercept 8 mg clinical study data now published in The Lancet bayer.com ↗
In the 12-week dosing group, 79% of nAMD patients and 91% of DME patients maintained this dosing interval with Eylea 8 mg with an average of 6 injections through week 48. |
| 2024-03-08 | Regeneron Pharmaceuticals | Results EYLEA® HD (aflibercept) Injection 8 mg Pivotal Data in Wet Age-related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME) Published in The Lancet regeneron.com ↗
today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for EYLEA® HD (aflibercept) Injection 8 mg. |
| 2024-02-26 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 아시아 안과 학회에서 SB15(아일리아 바이오시밀러) 임상 후속 연구 결과 발표 samsungbioepis.com ↗
그 결과 환자들의 56주에서 0주 대비 최대교정시력은 SB15 투여군에서 8.3글자, 오리지널 의약품 투여군에서 7.0글자, 교체 투여군에서 6.8 글자로 세 군에서 유사하게 향상됐다. |
| 2024-01-24 | Bayer | Regulatory Application for regulatory approval of Aflibercept 8 mg accepted in China bayer.com ↗
Bayer today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted the submission of an application for regulatory approval of aflibercept 8 mg for the treatment of neovascular (wet) age-related macular degeneration (nAMD). |
| 2024-01-18 | Santen Gmbh | Regulatory Japan Approval Obtained for Ophthalmic VEGF inhibitor Eylea®8mg Solution for Intravitreal Injection 114.3 mg/mL santen.com ↗
they had obtained regulatory approval from the Ministry of Health, Labour, and Welfare (MHLW) |
| 2024-01-18 | Bayer | Regulatory New Eylea™ 8 mg approved in Japan bayer.com ↗
The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted market authorization for Eylea™ 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). |
| 2024-01-08 | Bayer | Regulatory New Eylea™ 8 mg approved in EU bayer.com ↗
The European Commission has granted marketing authorization in the European Union (EU) for new Eylea™ 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) |
| 2024-01-03 | Alvotech Swiss AG | Results Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT06 and Reference Product Eylea® (aflibercept) alvotech.com ↗
The study met its primary endpoint, with results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea. |
| 2023-12-27 | Formycon AG | Regulatory Formycon announces EMA acceptance of the MAA for FYB203, a biosimilar candidate to Eylea® (Aflibercept) formycon.com ↗
Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (“Klinge”) announce that the European Medicines Agency (“EMA”) has accepted the marketing authorization application (“MAA”) for FYB203, a biosimilar candidate to Eylea® 1 (Active Ingredient: Aflibercept), for review. |
| 2023-11-27 | Formycon AG | Regulatory Formycon announces EMA submission for FYB203, a biosimilar candidate to Eylea® (Aflibercept) formycon.com ↗
Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Klinge Biopharma GmbH (Klinge) announce that the marketing authorization application (MAA) for FYB203, a biosimilar candidate for Eylea® 1 (Active ingredient: Aflibercept) has been submitted to the European Medicines Agency (EMA). |
| 2023-11-20 | ThromboGenics | Results Oxurion Discloses Topline Data from KALAHARI Phase 2, Part B Trial of Novel PKal Inhibitor THR-149 in Diabetic Macular Edema oxurion.com ↗
The mean change in best corrected visual acuity (BCVA) from baseline at Month 3 was -0.2 letters for the THR-149 arm and +3.5 letters for the aflibercept arm. |
| 2023-11-10 | Bayer | Regulatory Bayer’s aflibercept 8 mg recommended for approval in EU bayer.com ↗ |
| 2023-11-06 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Presents Clinical Data of Two Ophthalmic Bispecific Antibodies IBI302 (anti-VEGF/complement) and IBI324 (anti-VEGF-A/Ang-2) at American Academy of Ophthalmology (AAO) Annual Meeting 2023 innoventbio.com ↗
The mean change from baseline in BCVA at week 36 was +10.6 letters in the IBI302 2 mg group, +11.4 letters in the IBI302 4 mg group, and +12.0 letters in the aflibercept 2 mg group. |
| 2023-10-05 | Regeneron Pharmaceuticals | Results EYLEA® HD (aflibercept) Injection 8 mg Two-year Results from Pivotal PULSAR Trial in Wet Age-related Macular Degeneration Presented at EURETINA regeneron.com ↗
First presentation of long-term results demonstrated sustained visual and anatomic improvements among EYLEA HD patients through two years |
| 2023-09-26 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Positive Aflibercept Protein Level Data from the LUNA Phase 2 Trial adverum.com ↗
New data announced today include aflibercept protein levels for both the 2E11 and 6E10 vg/eye doses, suggesting that both doses are within the therapeutically active range. |
| 2023-08-29 | Formycon AG | Regulatory Formycon announces File Acceptance for FYB203, a biosimilar candidate to Eylea® (aflibercept), by the U.S. Food and Drug Administration (FDA) formycon.com ↗
The file acceptance by the FDA is another important milestone to bring our second biosimilar candidate in ophthalmology on track for approval in the U.S. |
| 2023-08-18 | Regeneron Pharmaceuticals | Regulatory EYLEA HD (aflibercept) Injection 8 mg Approved by FDA for Treatment of Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR). |
| 2023-08-15 | Sandoz | Results Sandoz announces positive results from Mylight Phase lll study for biosimilar aflibercept sandoz.com ↗
The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea®. |
| 2023-08-15 | Novartis Pharmaceuticals | Results Sandoz announces positive results from Mylight Phase lll study for biosimilar aflibercept novartis.com ↗
The Mylight Phase III confirmatory efficacy and safety study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and the reference biologic, Eylea®. |
| 2023-08-10 | Bayer | Results Aflibercept 8 mg first to achieve sustained vision gains with more than 70% of patients extended to intervals between 16 and 24 weeks in wet age-related macular degeneration at two years bayer.com ↗
Bayer today announced two-year (96 weeks) topline results of the pivotal clinical trial PULSAR in patients with neovascular (wet) age-related macular degeneration (nAMD). |
| 2023-08-10 | Regeneron Pharmaceuticals | Results Two-year PULSAR Trial Results for Aflibercept 8 mg Demonstrate Durable Vision Gains at Extended Dosing Intervals in Wet Age-related Macular Degeneration regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive, two-year (96 weeks), topline data from the pivotal PULSAR trial investigating aflibercept 8 mg in patients with wet age-related macular degeneration (wAMD). |
| 2023-08-03 | Regeneron Pharmaceuticals | Results Regeneron Reports Second Quarter 2023 Financial and Operating Results regeneron.com ↗
Two-year results reported for aflibercept 8 mg from pivotal PHOTON trial demonstrated durable vision gains at extended dosing intervals in diabetic macular edema (DME) |
| 2023-07-29 | Regeneron Pharmaceuticals | Results Aflibercept 8 mg Two-Year Results from Pivotal PHOTON Trial in Diabetic Macular Edema Presented at ASRS regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of positive two-year (96 weeks) results from the pivotal PHOTON trial investigating aflibercept 8 mg with 12- and 16-week dosing regimens, compared to EYLEA® (aflibercept) Injection, in patients with diabetic macular edema (DME). |
| 2023-07-20 | Hoffmann-La Roche | Results New clinical and real-world data for Roche’s Vabysmo at ASRS reveal improved outcomes for people with two leading causes of vision loss roche.com ↗
Late-breaking post-hoc data indicate Vabysmo leads to less fibrosis, which may negatively impact vision, than aflibercept in people with diabetic macular edema (DME) |
| 2023-07-19 | Genentech, Inc. | Results New Clinical and Real-World Data for Genentech’s Vabysmo at ASRS Reveal Improved Outcomes for People With Two Leading Causes of Vision Loss gene.com ↗
Late-breaking post-hoc data indicate Vabysmo leads to less fibrosis, which may negatively impact vision, than aflibercept in people with diabetic macular edema (DME) |
| 2023-06-29 | Formycon AG | Regulatory Formycon announces submission of the biologics license application (BLA) for FYB203, an aflibercept biosimilar candidate to the U.S. Food and Drug Administration (FDA) formycon.com ↗
the biologics license application (BLA) for FYB203, a biosimilar candidate for Eylea® 1 (Active ingredient: Aflibercept) has been submitted to the U.S. Food and Drug Administration („FDA“) in line with the initial schedule. |
| 2023-06-29 | Bayer | Results Aflibercept 8 mg in diabetic macular edema first to achieve sustained vision gains with up to 83% of patients extended to 16-24 weeks at two years bayer.com ↗
At two years (96 weeks), the aflibercept 8 mg groups demonstrated that 89% of patients maintained a ≥12-week dosing interval, compared to 93% through one year (48 weeks). |
| 2023-06-27 | Regeneron Pharmaceuticals | Results Two-year Results for Aflibercept 8 mg from Pivotal PHOTON Trial Demonstrate Durable Vision Gains at Extended Dosing Intervals in Diabetic Macular Edema regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced top-line, two-year (96 weeks) data for aflibercept 8 mg from the pivotal PHOTON trial in patients with diabetic macular edema (DME). |
| 2023-06-27 | Regeneron Pharmaceuticals | Regulatory FDA Issues Complete Response Letter (CRL) for Aflibercept 8 mg Biologics License Application Solely Due to an Ongoing Review of Inspection Findings at a Third-party Filler regeneron.com ↗
The CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested. |
| 2023-05-02 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Upcoming Data Presentations at ASGCT 2023 including Data on a New Intravitreal (IVT) Program for Geographic Atrophy Secondary to Dry AMD adverum.com ↗
Intravitreal Delivery of Ixo-vec for Neovascular Age-Related Macular Degeneration Results in Widespread Expression of Aflibercept in Cynomolgus Monkey Eyes as Confirmed Using In-Situ Hybridization |
| 2023-04-25 | Genentech, Inc. | Results New Vabysmo Data Suggest Greater Retinal Drying Versus Aflibercept in Wet Age-Related Macular Degeneration and Diabetic Macular Edema gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that post-hoc data indicate treatment with Vabysmo® (faricimab-svoa) led to greater and faster drying of retinal fluid with fewer injections compared to aflibercept in wet, or neovascular, age-related macular degeneration (AMD). |
| 2023-04-12 | Genentech, Inc. | Results Genentech Data Highlights Strength of Ophthalmology Portfolio and Commitment to Advancing Eye Care at ARVO 2023 gene.com ↗
A post-hoc analysis from the head-to-head dosing period of the Phase III TENAYA and LUCERNE studies suggests Vabysmo results in greater drying of retinal fluid compared to aflibercept in people with wet AMD. |
| 2023-03-01 | Bayer | Regulatory Bayer submits aflibercept 8 mg for marketing authorization in Japan bayer.com ↗
Bayer has submitted an application to the Japanese Ministry of Health, Labor, and Welfare (MHLW) seeking approval of aflibercept 8 mg for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). |
| 2023-02-23 | Regeneron Pharmaceuticals | Regulatory Aflibercept 8 mg BLA for Treatment of Wet Age-Related Macular Degeneration and Diabetic Macular Edema Accepted for FDA Priority Review regeneron.com ↗ |
| 2023-02-11 | Ocular Therapeutix, Inc. | Results Ocular Therapeutix™ Announces Interim 10-month Data from the Ongoing U.S. Phase 1 Clinical Trial Evaluating OTX-TKI for the Treatment of Wet AMD ocutx.com ↗
CSFT and BCVA measurements at 10 months were comparable between OTX-TKI treated subjects and aflibercept treated subjects |
| 2023-02-08 | Regeneron Pharmaceuticals | Regulatory EYLEA® (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat preterm infants with retinopathy of prematurity (ROP). |
| 2023-02-06 | Formycon AG | Results Aflibercept Biosimilar Candidate FYB203 shows comparable efficacy to the reference product Eylea®1 in Phase III Study formycon.com ↗
The FDA-specific interim analysis of the randomized, double-blind, multi-center phase III study met the primary efficacy endpoint, demonstrating comparable efficacy between FYB203 and the reference medicine Eylea ® in patients with neovascular age-related macular degeneration (nAMD). |
| 2023-02-06 | Bayer | Regulatory Bayer submits aflibercept 8 mg for regulatory approval in two major retinal eye diseases in the EU bayer.com ↗
Bayer has submitted an application for market authorization to the European Medicines Agency (EMA) for aflibercept 8 mg in two major retinal eye diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). |
| 2022-11-11 | Bayer | Regulatory Bayer receives positive CHMP opinion for Eylea™ in the EU for treatment of preterm infants with retinopathy of prematurity bayer.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for a label extension for Eylea™ (aflibercept) for intravitreal injection 40 mg/mL in a prefilled syringe (PFS) for the treatment of preterm infants with retinopathy of prematurity (ROP). |
| 2022-11-05 | Bayer | Results Detailed data from pivotal studies with aflibercept 8 mg demonstrate sustained improvements in visual acuity and anatomic measures with large majority of patients maintaining treatment intervals of 16 bayer.com ↗
Aflibercept 8 mg maintained 16-week dosing intervals in up to 89% of patients with as few as 5 injections until week 48 |
| 2022-11-04 | Regeneron Pharmaceuticals | Results Aflibercept 8 mg Late-breaking Data Presented at Retina Society in Diabetic Macular Edema and Wet Age-related Macular Degeneration regeneron.com ↗
Presentations reinforce that aflibercept 8 mg demonstrated non-inferior vision gains to EYLEA at 48 weeks, with 93% and 83% of patients in PHOTON and PULSAR, respectively, maintaining dosing intervals of 12 weeks or longer after initial monthly doses |
| 2022-10-21 | Regeneron Pharmaceuticals | Regulatory Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA® (aflibercept) Injection regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for EYLEA® (aflibercept) Injection. |
| 2022-10-12 | Regeneron Pharmaceuticals | Regulatory EYLEA® (aflibercept) Injection sBLA for Treatment of Retinopathy of Prematurity (ROP) Accepted for FDA Priority Review regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection to treat Retinopathy of Prematurity (ROP) in preterm infants. |
| 2022-09-30 | Regeneron Pharmaceuticals | Results Aflibercept 8 mg Positive Pivotal Results in Diabetic Macular Edema and Wet Age-Related Macular Degeneration Presented at AAO regeneron.com ↗
PHOTON and PULSAR data presentations demonstrate aflibercept 8 mg led to sustained improvements in vision and anatomic measures of retinal fluid across the 48-week treatment period in both 12- and 16-week dosing regimens |
| 2022-09-28 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 美 학회에서 SB15(아일리아 바이오시밀러) 임상 중간 결과 공개 samsungbioepis.com ↗
환자들의 최대 교정시력(BCVA)은 기준 시력 대비 SB15가 6.7글자, 오리지널 의약품이 6.6글자 향상되었으며 두 군 간의 차이는 사전에 정의한 동등성 기준을 만족했다. |
| 2022-09-26 | Santen Gmbh | Regulatory Ophthalmic VEGF inhibitor Eylea® Solution for Intravitreal Injection 40 mg/mL obtains approval for ROP as sixth indication santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter, “Santen”) and Bayer Yakuhin, Ltd. (head office: Osaka, Japan; hereafter "Bayer Yakuhin") announced today that, following an application by Bayer Yakuhin, they had obtained regulatory approval for an additional indication for ophthalmic Vascular endothelial growth factor (VEGF) inhibitor "Eylea® Intravitreal Injection 40 mg/mL" (aflibercept [recombinant] intravitreal injection; hereafter "Eylea®") for retinopathy of prematurity (ROP). |
| 2022-09-26 | Bayer | Regulatory Eylea® approved in Japan for treatment of preterm infants with retinopathy of prematurity bayer.com ↗
Bayer announced today that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Eylea® (aflibercept) intravitreal injection 40 mg/mL for the treatment of preterm infants with retinopathy of prematurity (ROP).* |
| 2022-09-08 | Bayer | Results Aflibercept 8 mg first to achieve extended injection intervals of 16 weeks in up to 89% of patients bayer.com ↗
Aflibercept 8 mg meets primary endpoints in two global pivotal studies in neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) achieving non-inferior improvements in best corrected visual acuity to Eylea® (aflibercept 2 mg) at week 48 |
| 2022-09-08 | Regeneron Pharmaceuticals | Results Aflibercept 8 mg Meets Primary Endpoints in Two Global Pivotal Trials for DME and wAMD, with a Vast Majority of Patients Maintained on 12- and 16-week Dosing Intervals regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the primary endpoints were met in two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). |
| 2022-06-29 | Regeneron Pharmaceuticals | Regulatory EYLEA® (aflibercept) Injection sBLA for Every 16-week Dosing Regimen in Patients with Diabetic Retinopathy Accepted for FDA Review regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the EYLEA® (aflibercept) Injection supplemental Biologics License Application (sBLA) for an every 16-week 2 mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy (DR). |
| 2022-05-17 | Adverum Biotechnologies, Inc. | Results Adverum Presents Data at ASGCT Further Supporting Phase 2 Development Plans for ADVM-022 adverum.com ↗
The human equivalent dose of 6E10 (3 X 10^10 vg/eye dose in NHP) demonstrated potential therapeutic levels in both aqueous humor and vitreous humor. |
| 2022-02-11 | Regeneron Pharmaceuticals | Results Regeneron Presents Encouraging Phase 2 Results for High-dose Aflibercept 8 mg in Wet Age-related Macular Degeneration at Angiogenesis Meeting regeneron.com ↗
In new results presented for the first time, aflibercept 8 mg continued to show numeric improvements in anatomical and vision outcomes compared to EYLEA through 44 weeks. |
| 2022-01-24 | Hoffmann-La Roche | Results The Lancet publishes studies showing Roche’s faricimab improved and maintained vision in two leading causes of vision loss, extending time between treatments up to four months roche.com ↗
All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that people treated with faricimab up to every four months achieved non-inferior vision gains compared to aflibercept given every two months. |
| 2021-11-10 | Bayer | Regulatory Bayer Submits Aflibercept for regulatory approval in the EU and Japan for Retinopathy of Prematurity in premature babies bayer.com ↗
Bayer has filed applications for a new therapeutic indication for aflibercept (solution for injection) in premature babies with treatment-requiring retinopathy of prematurity (ROP) in the EU and Japan. |
| 2021-08-24 | Regeneron Pharmaceuticals | Results Regeneron Announces Encouraging Topline Phase 2 Data of High-dose aflibercept in Wet Age-related Macular Degeneration regeneron.com ↗ |
| 2021-08-17 | Novartis Pharmaceuticals | Results Novartis announces positive results from Phase III trials of Beovu® in diabetic macular edema, including dosing intervals up to 16 weeks novartis.com ↗
Novartis today announced positive results from two Phase III clinical trials assessing Beovu ® (brolucizumab) 6 mg versus aflibercept 2 mg in patients with diabetic macular edema (DME). |
| 2021-05-28 | Novartis Pharmaceuticals | Results Novartis reports one year results of Phase III MERLIN study evaluating Beovu® every four week dosing and provides update on Beovu clinical program novartis.com ↗ |
| 2021-05-01 | Novartis Pharmaceuticals | Results Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept novartis.com ↗
In KESTREL, patients on Beovu 6 mg gained a mean of 9.2 letters versus 10.5 letters for patients on aflibercept 2 mg 1 . |
| 2021-03-30 | Regeneron Pharmaceuticals | Results NIH-sponsored Trial Finds EYLEA® (aflibercept) Injection Reduced Vision-threatening Complications by 68% after Two Years in Diabetic Retinopathy Patients regeneron.com ↗
At two years, the primary outcome of the trial showed a 68% reduced risk of developing vision-threatening complications (either proliferative diabetic retinopathy [PDR] or CI-DME with vision loss) in patients who received the EYLEA every-16-weeks dosing regimen. |
| 2020-12-21 | Hoffmann-La Roche | Results Roche’s faricimab meets primary endpoint and shows strong durability across two global phase III studies for diabetic macular edema, a leading cause of blindness roche.com ↗
Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalised dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. |
| 2020-10-05 | Novartis Pharmaceuticals | Results New Phase III analysis demonstrates Novartis Beovu® showed improvement in best-corrected visual acuity in wet AMD patients with early persistent fluid novartis.com ↗ |
| 2020-09-14 | Novartis Pharmaceuticals | Results Novartis reports positive topline results from the first Phase III trial of Beovu® versus aflibercept in patients with diabetic macular edema (DME) novartis.com ↗
The trial met its primary and key secondary endpoints, demonstrating non-inferiority for Beovu versus aflibercept 2 mg in mean change in best-corrected visual acuity (BCVA) at year one (week 52) 1 . |
| 2020-07-27 | Novartis Pharmaceuticals | Results New Novartis analysis shows wet AMD patients achieved sustained fluid control faster with Beovu® versus aflibercept novartis.com ↗
In both trials, >=50% of patients achieved sustained dryness faster with Beovu (by weeks 8 and 4 in HAWK and HARRIER, respectively, and by weeks 12 and 8 with aflibercept) 1 . |
| 2020-02-08 | Regeneron Pharmaceuticals | Results EYLEA® (aflibercept) Injection Reduced Risk of Developing Vision-Threatening Events by 75% After Two Years in Patients with Diabetic Retinopathy regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced positive two-year results from the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) Injection 2 mg (0.05 mL) in patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR). |
| 2019-08-13 | Regeneron Pharmaceuticals | Regulatory FDA Approves EYLEA® (aflibercept) Injection Prefilled Syringe regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the EYLEA® (aflibercept) Injection prefilled syringe. |
| 2019-05-13 | Regeneron Pharmaceuticals | Regulatory FDA Approves EYLEA® (aflibercept) Injection for Diabetic Retinopathy regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness. |
| 2019-02-09 | Regeneron Pharmaceuticals | Results One-Year Results from Positive Phase 3 EYLEA Trial in Diabetic Retinopathy Presented at Angiogenesis Symposium regeneron.com ↗
Most importantly, EYLEA treatment prevented approximately 74% of these complications. |
| 2018-10-27 | Novartis Pharmaceuticals | Results Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD novartis.com ↗
Superior reductions in central subfield thickness demonstrated at year one were reaffirmed at year two with brolucizumab 6 mg versus aflibercept |
| 2018-10-25 | Regeneron Pharmaceuticals | Results EYLEA® (aflibercept) Injection Improves Diabetic Retinopathy and Reduces Vision-Threatening Complications in Phase 3 Trial regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) Injection in patients with moderately severe and severe non-proliferative diabetic retinopathy (NPDR) met its one-year (52-week) primary endpoint and key secondary endpoints. |
| 2018-10-17 | Adverum Biotechnologies, Inc. | Results Adverum Biotechnologies Announces Data Presented at the European Society of Gene and Cell Therapy (ESGCT) adverum.com ↗
A single intravitreal injection of ADVM-022 in non-human primates (NHP) demonstrated durable expression of aflibercept sustained out to 22 months |
| 2018-09-22 | Novartis Pharmaceuticals | Results New analysis of Novartis Phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD novartis.com ↗
The data show that brolucizumab 6 mg had superior fluid resolution versus aflibercept over four visits during weeks 36 to 48. |
| 2018-09-13 | Regeneron Pharmaceuticals | Regulatory FDA to Review EYLEA® (aflibercept) Injection for the Treatment of Diabetic Retinopathy regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. |
| 2018-08-17 | Regeneron Pharmaceuticals | Regulatory FDA Approves EYLEA® (aflibercept) Injection sBLA in Wet Age-related Macular Degeneration regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). |
| 2018-08-13 | Regeneron Pharmaceuticals | Regulatory Regeneron Provides Regulatory Update on EYLEA® (aflibercept) Injection sBLA in Wet Age-Related Macular Degeneration regeneron.com ↗
the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). |
| 2018-08-01 | Bayer | Regulatory Bayer receives approval of new treatment regimen for Eylea® in the EU bayer.com ↗
Bayer announced today that the European Commission has approved a new treatment approach for Eylea® to enable clinicians to combine proactive treatment with early extension of the injection interval for patients with neovascular age-related macular degeneration (nAMD). |
| 2018-05-11 | Bayer | Regulatory Bayer receives approval for Eylea® in China bayer.com ↗
Bayer announced today that Eylea® (aflibercept solution for injection into the eye) has been approved by the Chinese regulatory authorities for the treatment of visual impairment due to neovascular (wet) age-related macular degeneration (wAMD). |
| 2018-03-19 | Regeneron Pharmaceuticals | Results EYLEA® (aflibercept) Injection Demonstrates Positive Topline Results in Phase 3 Non-Proliferative Diabetic Retinopathy Trial regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the Phase 3 PANORAMA trial evaluating EYLEA® (aflibercept) Injection in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) met its 24-week primary endpoint. |
| 2018-02-13 | Bayer | Regulatory Bayer receives first approval for Eylea® in China bayer.com ↗
Bayer announced today that Eylea® (aflibercept solution for injection into the eye) has been approved by the Chinese State Food and Drug Administration (CFDA) for the treatment of visual impairment due to diabetic macular edema (DME). |
| 2018-02-12 | Bayer | Results New data for aflibercept show prolonged injection intervals bayer.com ↗
The proposed label change is based on data from the recently presented ALTAIR trial, where at the end of the first year approximately 60% of patients on Eylea had their next scheduled appointment at an interval of 12 weeks or more. |
| 2017-12-11 | Regeneron Pharmaceuticals | Regulatory Regeneron Announces FDA Acceptance of sBLA Filing for 12-Week Dosing of EYLEA® (aflibercept) Injection for Patients with Wet AMD regeneron.com ↗
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's supplemental Biologics License Application (sBLA) for a 12-week dosing interval of EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD) based on physician's assessment. |
| 2017-11-27 | Regeneron Pharmaceuticals | Results Regeneron Provides Update on EYLEA® (aflibercept) Injection and Nesvacumab (Ang2 Antibody) Combination Program regeneron.com ↗
EYLEA results were consistent with findings in previous clinical studies. |
| 2017-11-10 | Novartis Pharmaceuticals | Results Novartis brolucizumab (RTH258) demonstrates superiority versus aflibercept in key secondary endpoint measures of disease activity in nAMD, a leading cause of blindness novartis.com ↗
Novartis, a global leader in ophthalmology, announced further positive results from two Phase III studies of brolucizumab versus aflibercept. |
| 2017-06-20 | Novartis Pharmaceuticals | Results Novartis RTH258 (brolucizumab) demonstrates robust visual gains in nAMD patients with a majority on a 12-week injection interval novartis.com ↗ |
All press releases naming this drug 164 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 164 releases opens the full record — a long page | ||
Evidence & citations 25 cited values
Every value below carries the sentence it was read from. 454 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aflibercept | “Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used...” NCT02457975 ↗386“PURPOSE: To determine the maximum tolerated dose or maximal administered dose and pharmacokinetic and safety profiles of s.c. administered vascular endothelial growth factor...” PMID 20028764 ↗ Dec 2009 “Vascular endothelial growth factor (VEGF) Trap (aflibercept) is an angiogenesis inhibitor comprising portions of the extracellular domains of human VEGF receptors 1 and 2 fused...” PMID 19949018 ↗ Nov 2009 “Randomised, double-masked trial to compare the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular...” PMID 41494750 ↗ Jan 2026 “COLLIDE is a multi-center, open-label, 1:1 randomized study looking at the effects of aflibercept (AFL; 2.0mg) plus OZURDEX (DEX; 0.7mg) implant combination therapy versus DEX...” NCT03629210 ↗ “Efficacy of Intravitreal Aflibercept Monotherapy for Submacular Hemorrhage Secondary to Neovascular Age-Related Macular Degeneration: A Prospective Clinical Trial” NCT03169660 ↗ “Anti-VEGFs including ranibizumab and biosimilars, aflibercept, faricimab, and brolucizumab will be used, as per the standard of care at participating sites.” NCT06985706 ↗ “Objective: To compare efficacy and safety of MYL-1701P, an aflibercept biosimilar, with reference aflibercept (Eylea [Regeneron]) in DME.” PMID 39264599 ↗ Oct 2024 “Outcome of Brolucizumab-dbll and Aflibercept Intravitreal Injection in the Treatment of Age-related Macular Neovascular Degeneration” NCT04882956 ↗ “Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).” NCT01331681 ↗ “Aflibercept 2 mg (0.05 ml) will be administered by intravitreal injection every month for three consecutive months.” NCT06845163 ↗ |
| Known as | AFL | “EYLEA® (AFL 2.0 mg intravitreal injections) is an anti-VEGF treatment.” NCT03629210 ↗ |
| Known as | AFLB | “Aflibercept (AFLB) 2 mg IVT” NCT07064759 ↗1“Aflibercept (AFLB) 2 mg IVT” NCT06864988 ↗ |
| Known as | Aflibercept (Eylea) | “Aflibercept (Eylea)” NCT06845163 ↗ |
| Known as | aflibercept HD | “Eylea HD (aflibercept HD)” NCT07489131 ↗ |
| Known as | AVE0005 | “To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants...” NCT00284141 ↗15“A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients...” NCT00644124 ↗ “Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00532155 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00561470 ↗ “aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00327444 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00396591 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00327171 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00574275 ↗ “Drug: aflibercept (AVE0005)” NCT00545246 ↗ “Aflibercept (AVE0005)” NCT01148615 ↗ “aflibercept (AVE0005)” NCT00876044 ↗ |
| Known as | BAY86-5321 | “The study treatment Aflibercept (also called BAY 86-5321) is a drug that blocks a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and...” NCT06591598 ↗25“Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).” NCT01331681 ↗ “Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)” NCT01363440 ↗ “Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)” NCT02581891 ↗ “Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)” NCT01521559 ↗ “Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose” NCT05850520 ↗ “Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)” NCT00637377 ↗ “Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)” NCT01012973 ↗ “Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)” NCT02540954 ↗ “Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)” NCT05511038 ↗ “Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)” NCT01482910 ↗ |
| Known as | Eylea | “Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used...” NCT02457975 ↗90“A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the...” NCT02214628 ↗ “InCNV is treated at the moment with off-label anti-VEGF (Vascular Endothelial Growth Factor) therapy and could also benefit from aflibercept (EYLEA), a new anti-VEGF currently...” NCT02556229 ↗ “Each eye will receive three to five q4week loading anti-VEGF injections of aflibercept (2-mg, EYLEA®) after enrollment to complete the initial loading phase of 5 doses.” NCT06610747 ↗ “The purpose of this study is to compare the safety and efficacy of intravitreal Eylea injections at a set interval, versus a variable dosing schedule” NCT02392364 ↗ “The included patients received 5 loading doses of intravitreal Aflibercept (2.0 mg/0.05 mL) (Eylea; Bayer, Berlin, Germany) given monthly.” NCT03974425 ↗ “Subjects will receive monthly intravitreous injections of Avacincaptad Pegol in combination with Lucentis, Avastin or Eylea.” NCT02397954 ↗ “Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).” NCT01331681 ↗ “Effect of Aflibercept (Eylea®) in the Management of Bevacizumab (Avastin®) Resistant Diabetic Macular Edema” NCT02924987 ↗ “Biological: Aflibercept IVT * Commercially available Active Comparator * Other Names: Eylea” NCT06942520 ↗ “intravitreal injection of Anti-VEGF Aflibercept (Eylea®; manufactured in the United States)” NCT05282420 ↗ |
| Known as | EYLEA (aflibercept) Injection | “EYLEA® (aflibercept) Injection” NCT02712008 ↗ |
| Known as | Eylea HD | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07489131 ↗ |
| Known as | Eylea is the brand name. | “Eylea is the brand name.” NCT02142296 ↗ |
| Known as | FYB203 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06708637 ↗ |
| Known as | IAI | “The purpose of this study is to evaluate the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with neovascular polypoidal choroidal vasculopathy.” NCT02092532 ↗3“Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)” NCT01521559 ↗ “Intravitreal Aflibercept Injection (IAI)” NCT01722045 ↗ “Intravitreal Aflibercept Injection (IAI)” NCT02713204 ↗ |
| Known as | IVT-AFL | “The VEGA trial assessed the efficacy and safety of intravitreal aflibercept (IVT-AFL) in patients with neovascular glaucoma in a 13-week, randomized, double-masked,...” PMID 33330958 ↗ Dec 20201“intravitreal aflibercept (IVT-AFL)” PMID 33556381 ↗ Feb 2021 |
| Known as | REGN3 | “Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)” NCT02712008 ↗ |
| Known as | vascular endothelial growth factor (VEGF) Trap | “Aflibercept, also known as vascular endothelial growth factor (VEGF) Trap, is an angiogenesis inhibitor with a unique mechanism of action.” NCT02624726 ↗ |
| Known as | VEGF Trap | “Vascular endothelial growth factor (VEGF) Trap (aflibercept) is an angiogenesis inhibitor comprising portions of the extracellular domains of human VEGF receptors 1 and 2 fused...” PMID 19949018 ↗ Nov 20095“A Phase I Open-label Dose-escalation Study of Intravenous Aflibercept (AVE0005, VEGF Trap) in Combination With R-CHOP Administered Every 2 Weeks or Every 3 Weeks in Patients...” NCT00644124 ↗ “An Exploratory Study of the Safety, Tolerability and Biological Effect of a Single Intravitreal Administration of VEGF Trap in Patients With Diabetic Macular Edema” NCT00320814 ↗ “Aflibercept (VEGF Trap) Recombinant human protein, at 25 mg/ml Dose : 4 mg/Kg -Day 1, q2w Route of administration: Intravenous (60 min infusion)” NCT01802684 ↗ |
| Known as | VEGF Trap-Eye | “Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).” NCT01331681 ↗21“intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany)” PMID 23084240 ↗ Oct 2012 “Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)” NCT02581891 ↗ “Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)” NCT00527423 ↗ “Aflibercept, VEGF Trap-Eye(Eylea, BAY86-5321)_higher dose” NCT05850520 ↗ “Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)” NCT00637377 ↗ “Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)” NCT01012973 ↗ “VEGF Trap-Eye (Intravitreal Aflibercept Injection [IAI])” NCT01521559 ↗ “VEGF Trap-Eye (Intravitreal Aflibercept Injection)” NCT01722045 ↗ “Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)” NCT05511038 ↗ “Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)” NCT02540954 ↗ |
| Known as | Zaltrap | “To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants...” NCT00284141 ↗9“Ziv-aflibercept (Zaltrap, Regeneron) is a recombinant fusion protein that acts as a soluble decoy receptor” NCT02590094 ↗ “aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus)” NCT04810585 ↗ “Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00532155 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00396591 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00561470 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00327171 ↗ “aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00327444 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00574275 ↗ “Drug: Ziv-Aflibercept 25 MG/ML [Zaltrap]” NCT03423823 ↗ |
| Known as | Zhuochuming | “Aflibercept Intravitreal Injection (Zhuochuming®)” NCT07612904 ↗ |
| Known as | ziv-aflibercept | “To determine the overall objective response rate (ORR) of AVE0005 (ziv-aflibercept, aflibercept, VEGF trap, ZALTRAP®) 4.0 mg/kg intravenously (IV) every 2 weeks in participants...” NCT00284141 ↗48“The MTD and RPTD were: capecitabine 850 mg/m2, P.O. bid, days 1-14, and ziv-aflibercept 6 mg/kg I.V., day 1, of each 21-day cycle.” PMID 31675952 ↗ Nov 2019 “* Ziv-aflibercept: will be administered 4 mg/kg IV on Day 1 of each cycle, repeating every 14 days.” NCT02079220 ↗ “Patients receive a higher dose of ziv-aflibercept (VEGF Trap) IV over 1 hour on day 1.” NCT00357760 ↗ “Drug: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00532155 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00561470 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00396591 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00327171 ↗ “Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00574275 ↗ “aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)” NCT00327444 ↗ “In the US, the US proper name is "ziv-aflibercept".” NCT02085005 ↗ |
| Action | Inhibit | “Evaluate the ability of this drug to bind and inactivate circulating vascular endothelial growth factor (VEGF) in these patients.” NCT00036946 ↗ |
| Modality | Protein / enzyme biologic | “comprising portions of the extracellular domains of human VEGF receptors 1 and 2 fused to the Fc portion of human immunoglobulin G” PMID 19949018 ↗ Nov 2009 |
| Route | Subcutaneous | “aflibercept administered subcutaneously to patients with advanced solid tumors.” PMID 20028764 ↗ Dec 2009 |
| Target | VEGFA | “By binding to VEGF-A, aflibercept prevents activation of the native VEGF receptors, VEGFR-1 and VEGFR-2.” NCT02432547 ↗ |