Ranibizumab
Monoclonal antibody targets VEGFA via inhibition
Regulatory milestones approvals, filings & regulatory actions · 24 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed choroidal neovascularization 1 milestone | |||||
| Filed | US (FDA) | Lucentis | choroidal neovascularization | 2016-10-10 | “FDA has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis® (ranibizumab injection) for the treatment of myopic choroidal...” gene.com ↗ |
| Filed diabetic macular edema 1 milestone | |||||
| Filed | US (FDA) | Susvimo | diabetic macular edema | 2024-07-18 | “Additionally, the FDA has accepted the filing application for Susvimo in DME and DR based on one-year Pagoda and Pavilion study data” gene.com ↗ |
| Filed perifoveal exudative vascular anomalous complex 1 milestone | |||||
| Filed | EU (EMA) | Susvimo | perifoveal exudative vascular anomalous complex | — | “Susvimo® (ranibizumab injection) 100 mg/mL is currently under review with the European Medicines Agency (EMA) for the treatment of nAMD.” roche.com ↗ |
| Filed wet macular degeneration 3 milestones | |||||
| Filed | EU (EMA) | — | wet macular degeneration | 2021-09-09 | “a Marketing Authorization Application (MAA) for biosimilar ranibizumab submitted by its co-development and commercialization partner, STADA Arzneimittel AG, has been validated...” xbrane.com ↗ |
| Filed | US (FDA) | — | wet macular degeneration | 2021-06-23 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System...” gene.com ↗ “submitted a biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) for their biosimilar candidate of the ophthalmological drug Ranibizumab” polpharmabiologics.com ↗ “FDA has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS)” gene.com ↗ “Xbrane submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA in April 2023” xbrane.com ↗ |
| Filed | EU (EMA) | — | wet macular degeneration | 2021-06-23 | “The European Medicines Agency has also validated the PDS Marketing Authorization Application in wet AMD” gene.com ↗ “The European Medicines Agency has also validated the PDS Marketing Authorisation Application in nAMD” roche.com ↗ |
| Rejected retinal disorder 2 milestones | |||||
| Rejected (CRL) | US (FDA) | — | retinal disorder | 2025-10-19 | “FDA has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate” xbrane.com ↗ |
| Rejected (CRL) | US (FDA) | — | retinal disorder | 2024-04-21 | “U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate” xbrane.com ↗ |
| Approved Indication not stated 7 milestones | |||||
| Label expansions (2) | US (FDA) | SUSVIMO | — | 2025-02-03 – 2025-05-21 | fda.gov ↗ |
| Filed | US (FDA) | — | age-related macular degeneration, retinal vein occlusion, myopic choroidal neovascularization | 2024-12-31 | “has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to FDA” xbrane.com ↗ |
| Filed | US (FDA) | Ximluci | age-related macular degeneration, retinal vein occlusion, myopic choroidal neovascularization | 2023-04-24 | “Xbrane has submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA.” xbrane.com ↗ |
| Filed | US (FDA) | CIMERLI | — | 2022-02-17 | “FDA accepted for review the BLA for CIMERLI™ (ranibizumab-ranq), a Lucentis® biosimilar, and assigned a target action date in August 2022.” coherus.com ↗ |
| Label expansions (9) | US (FDA) | LUCENTIS | — | 2008-04-23 – 2017-04-15 | fda.gov ↗ |
| Approved | EU (EMA) | Lucentis | — | 2007-01-22 | europa.eu ↗ |
| Approved | US (FDA) | LUCENTIS | — | 2006-06-30 | fda.gov ↗ |
Trials 306 · started per year
News releases announcing trial results or a regulatory action · 100
| Date | Issuer | Release |
|---|---|---|
| 2026-09-21 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Susvimo® for the treatment of neovascular age-related macular degeneration (nAMD) roche.com ↗ |
| 2026-07-24 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Susvimo, the first continuous delivery treatment for neovascular age-related macular degeneration (nAMD) roche.com ↗
Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of neovascular age-related macular degeneration (nAMD). |
| 2026-06-05 | Lupin Limited | Regulatory Lupin Receives Approval from U.S. FDA for RanluspecTM (ranibizumab) Injection lupin.com ↗
Mumbai, India, Naples, Fla., June 5, 2026: Global pharma major Lupin Limited (Lupin) today announced that the United States Food and Drug Administration (U.S. FDA) has approved its ranibizumab, Ranluspec™ (ranibizumab-hkdz), as an interchangeable biosimilar referencing Lucentis® (Genentech). |
| 2026-06-03 | Xbrane Biopharma AB | Regulatory Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) receives FDA BsUFA date of October 29, 2026 for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) xbrane.com ↗
Xbrane Biopharma AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for the Company's investigational biosimilar candidate to LUCENTIS® (ranibizumab) and set a BsUFA (Biosimilar User Fee Act) action date of October 29, 2026. |
| 2026-04-30 | Xbrane Biopharma AB | Regulatory XBRANE SUBMITS RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA xbrane.com ↗
Xbrane has therefore resubmitted the BLA. |
| 2026-04-29 | Genentech, Inc. | Results Genentech to Present Extensive Data Showcasing Its Industry-Leading Ophthalmology Portfolio at ARVO 2026 gene.com ↗
Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden |
| 2025-12-23 | Zydus Lifesciences Limited | Regulatory Zydus Partners with Bioeq for U.S. Commercialisation rights for NUFYMCO®, an Interchangeable Biosimilar to Lucentis®. NUFYMCO® BLA has been approved by the USFDA zyduslife.com ↗
The Biologics License Application (BLA) for NUFYMCO® has been approved by U.S. Food and Drug Administration (USFDA) on December 18, 2025. |
| 2025-12-23 | Formycon AG | Regulatory FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner formycon.com ↗ |
| 2025-12-23 | Polpharma Biologics S.A. | Regulatory Bioeq and Zydus partners for U.S. Commercialisation rights for NUFYMCO®, an Interchangeable Biosimilar to Lucentis®. NUFYMCO® BLA has been approved by the USFDA polpharmabiologics.com ↗
The Biologics License Application (BLA) for NUFYMCO® has been approved by the U.S. Food and Drug Administration (USFDA), representing a significant milestone in expanding access to high-quality, affordable ophthalmology treatments in the United States. |
| 2025-10-19 | Xbrane Biopharma AB | Regulatory Xbrane provides Regulatory update on FDA review of its ranibizumab biosimilar candidate xbrane.com ↗
Xbrane has during the weekend received a CRL from FDA stating unresolved observations following the inspection at one of the production sites without further specification. |
| 2025-09-04 | Hoffmann-La Roche | Regulatory Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD) roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the EU CE mark for its Port Delivery Platform containing Susvimo, which will now be known as Contivue® in the EU. |
| 2025-08-01 | Hoffmann-La Roche | Results Roche’s Susvimo maintains vision over five years with two refills per year in people with neovascular age-related macular degeneration (nAMD) roche.com ↗
Results show that Susvimo’s immediate and predictable durability was sustained over five years, with approximately 95% of people receiving treatment every six months requiring no supplemental treatment before each refill. |
| 2025-08-01 | Genentech, Inc. | Results Genentech’s Susvimo Maintains Vision Over Five Years With Two Refills Per Year in People With Wet Age-Related Macular Degeneration (AMD) gene.com ↗
Results show that Susvimo’s immediate and predictable durability was sustained over five years, with approximately 95% of people receiving treatment every six months requiring no supplemental treatment before each refill. |
| 2025-06-05 | Formycon AG | Regulatory Lucentis® biosimilar FYB201/Ranivisio® (ranibizumab) approved in Brazil formycon.com ↗
Formycon AG (FSE: FYB, “Formycon”) today announces that the Brazilian regulatory authority ANVISA has granted marketing authorization for Ranivisio ®1 , a biosimilar to Lucentis ®2 (ranibizumab). |
| 2025-06-04 | Polpharma Biologics S.A. | Regulatory Lucentis® biosimiliar Ranivisio® (ranibizumab) approved as a new treatment for debilitating retinopathies in Brazil polpharmabiologics.com ↗
Amsterdam, Munich – Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce that the Brazilian Health Regulatory Agency (ANVISA) has approved Ranivisio ® * (ranibizumab) as a biosimilar to Lucentis ®** for the treatment of debilitating retinopathies in Brazil. |
| 2025-05-23 | Xbrane Biopharma AB | Regulatory Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) updates on US FDA BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) xbrane.com ↗
FDA has now communicated October 21 st 2025 as the BsUFA date (decision date). |
| 2025-05-22 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Susvimo for diabetic retinopathy roche.com ↗ |
| 2025-05-22 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Susvimo for Diabetic Retinopathy gene.com ↗
FDA Approves Genentech’s Susvimo for Diabetic Retinopathy |
| 2025-02-04 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness roche.com ↗ |
| 2025-02-04 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness gene.com ↗
FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness |
| 2024-12-31 | Xbrane Biopharma AB | Regulatory XBRANE RE-SUBMITS BLA FOR RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA xbrane.com ↗
Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to FDA (US Food and Drug Administration). |
| 2024-08-05 | Lupin Limited | Results Lupin Announces Successful Completion of Phase 3 Trials for Lucentis® Biosimilar lupin.com ↗
The study has achieved its primary endpoint of therapeutic equivalence in visual acuity improvement for wet AMD patients, showcasing comparable safety and immunogenicity between LUBT010 and Lucentis. |
| 2024-07-18 | Hoffmann-La Roche | Results New data for Roche’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions roche.com ↗
The results build on the primary one-year analyses of the Pagoda and Pavilion studies, with Susvimo demonstrating sustained efficacy over two years and safety consistent with the known safety profile for Susvimo in people with DME and DR. |
| 2024-07-18 | Genentech, Inc. | Results New Data for Genentech’s Susvimo Demonstrates Sustained Efficacy in Two Serious Diabetic Eye Conditions gene.com ↗
The results build on the primary one-year analyses of the Pagoda and Pavilion studies, with Susvimo demonstrating sustained efficacy over two years and safety consistent with the known safety profile for Susvimo in people with DME and DR. |
| 2024-07-08 | Hoffmann-La Roche | Regulatory Roche to reintroduce Susvimo in the US for people with neovascular age-related macular degeneration (nAMD) roche.com ↗
The US Food and Drug Administration (FDA) has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting component-level updates made to the ocular implant and refill needle. |
| 2024-07-08 | Genentech, Inc. | Regulatory Genentech to Reintroduce Susvimo for People With Wet Age-Related Macular Degeneration (AMD) gene.com ↗
The U.S. Food and Drug Administration (FDA) has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting component-level updates made to the ocular implant and refill needle. |
| 2024-04-21 | Xbrane Biopharma AB | Regulatory Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate xbrane.com ↗
FDA requested a tighter specification on one analytical method. |
| 2024-03-11 | Formycon AG | Regulatory FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region formycon.com ↗
Formycon AG (FSE: FYB) and MS Pharma announced today that FYB201, a biosimilar to Lucentis ® (Ranibizumab), has received marketing authorization from the Saudi Food & Drug Authority. |
| 2023-12-07 | Formycon AG | Regulatory Health Canada approves FYB201/Ranopto® (Ranibizumab), a biosimilar to Lucentis® formycon.com ↗
Formycon AG, Polpharma Biologics Group BV, Bioeq AG and Teva Canada Ltd. jointly announce that Health Canada has granted the “Notice of Compliance” (NOC) for Ranopto ®1 (Ranibizumab), a biosimilar to Lucentis ®2 , for the treatment of several serious retinal diseases in Canada. |
| 2023-06-21 | Xbrane Biopharma AB | Regulatory Xbrane announce U.S. FDA filing acceptance for a Lucentis® (ranibizumab) biosimilar candidate xbrane.com ↗
Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) today announced the acceptance of the supplemental Biologics License Application (sBLA) for a Lucentis® (ranibizumab) biosimilar candidate by the US Food and Drug Administration (FDA). |
| 2023-04-24 | Xbrane Biopharma AB | Regulatory XBRANE submits BLA for ranibizumab biosimilar candidate to FDA xbrane.com ↗
Xbrane has submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA. |
| 2023-02-13 | Coherus Oncology, Inc. | Regulatory Coherus Granted Permanent, Product-Specific Q-Code for CIMERLI® (ranibizumab-eqrn) from the Centers for Medicare and Medicaid Services coherus.com ↗
The HCPCS Q-code assigned to CIMERLI® will be effective for patients administered CIMERLI® on or after April 1, 2023. |
| 2023-01-17 | Xbrane Biopharma AB | Regulatory STADA and Xbrane obtain British approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis® xbrane.com ↗
STADA Arzneimittel AG and Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE) announce that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci® (ranibizumab), a biosimilar referencing Lucentis®. |
| 2022-11-11 | Xbrane Biopharma AB | Regulatory STADA and Xbrane secure EU approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis® xbrane.com ↗
STADA Arzneimittel AG and Xbrane Biopharma AB (Nasdaq Stockholm: XBRANE) announce that the European Commission has granted a marketing authorization for Ximluci® (ranibizumab), a biosimilar candidate referencing Lucentis®. |
| 2022-09-16 | Xbrane Biopharma AB | Regulatory STADA and Xbrane welcome EMA positive opinion for ranibizumab biosimilar candidate Ximluci xbrane.com ↗ |
| 2022-09-02 | Polpharma Biologics S.A. | Regulatory European Commission approves FYB201/Ranivisio®1 (Ranivisio – Ranibizumab), a biosimilar to Lucentis®2 polpharmabiologics.com ↗ |
| 2022-08-29 | Formycon AG | Regulatory European Commission approves FYB201/Ranivisio®1 (Ranivisio - Ranibizumab), a biosimilar to Lucentis®2 formycon.com ↗ |
| 2022-08-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory European Commission grants marketing authorization for Ranivisio▼®* (ranibizumab), a biosimilar to Lucentis®**, for age-related macular degeneration (AMD) the most common cause of blindness in developed countries tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. announces that the European Commission (EC) has granted a Marketing Authorization for Ranivisio (ranibizumab), a biosimilar of the ophthalmology treatment Lucentis across all five indications in adults for which Lucentisis authorized. |
| 2022-08-26 | Formycon AG | Regulatory Formycon announces EU-Approval of FYB201/Ranivisio®1 a biosimilar to Lucentis®2 formycon.com ↗
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the European Commission (“EC”) today has granted marketing authorization (“MA”) for Ranivisio ® , a biosimilar to Lucentis ® (ranibizumab-injection) for medical use in the European Union (“EU”). |
| 2022-08-05 | Polpharma Biologics S.A. | Regulatory U.S. Food and Drug Administration (FDA) approves FYB201/CIMERLI™* (ranibizumab-eqrn), the first and only biosimilar interchangeable with Lucentis®** polpharmabiologics.com ↗
jointly announce that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis ® (ranibizumab injection). |
| 2022-08-04 | Coherus Oncology, Inc. | Regulatory Coherus BioSciences Reports Second Quarter 2022 Results and Provides Business Update coherus.com ↗
The U.S. Food and Drug Administration (FDA) has approved CIMERLI™ (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all five indications, with 12 months of interchangeability exclusivity. |
| 2022-08-03 | Formycon AG | Regulatory U.S. Food and Drug Administration (FDA) approved FYB201/CIMERLITM1 (ranibizumab-eqrn), the first and only biosimilar interchangeable with Lucentis®2 formycon.com ↗
Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce, that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection). |
| 2022-08-03 | Formycon AG | Regulatory Formycon announces FDA approval of FYB201/CIMERLITM1 (ranibizumab-eqrn) as a Biosimilar interchangeable with Lucentis®2 formycon.com ↗
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) announces that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection). |
| 2022-08-02 | Coherus Oncology, Inc. | Regulatory FDA Approves Coherus’ CIMERLI™ (ranibizumab-eqrn) as the First and Only Interchangeable Biosimilar to Lucentis® for All Five Indications, with 12 Months of Interchangeability Exclusivity coherus.com ↗ |
| 2022-07-06 | Polpharma Biologics S.A. | Regulatory MHRA’s authorization for BIOEQ’s biosimilar in the United Kingdom. polpharmabiologics.com ↗
Mamy przyjemność poinformować, że Brytyjska Agencja do Spraw Regulacji Leków i Produktów Ochrony Zdrowia (Medicines and Healthcare Products Regulatory Agency, MHRA) wydała pozwolenie dopuszczające do sprzedaży w Wielkiej Brytanii lek biologiczny ranibizumab (FYB201), biopodobny do Lucentis ®1 . |
| 2022-07-04 | Xbrane Biopharma AB | Regulatory Xbrane provides update on ranibizumab biosimilar candidate FDA filing xbrane.com ↗
Xbrane has now received a General Advice letter with comments and recommendations for the resubmission. |
| 2022-06-24 | Formycon AG | Regulatory FYB201, Formycon's biosimilar for Lucentis® (ranibizumab), receives CHMP recommendation from EMA formycon.com ↗
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its licensing partner Bioeq AG (“Bioeq”) announce that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) today issued a positive opinion for FYB201, a biosimilar to Lucentis®1. |
| 2022-05-30 | Xbrane Biopharma AB | Regulatory Xbrane provides update on ranibizumab biosimilar candidate FDA filing xbrane.com ↗
Xbrane Biopharma AB (publ) ("Xbrane" or "the Company") (Nasdaq Stockholm: XBRANE) has withdrawn the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® after receiving feedback from the FDA (U.S. Food and Drug Administration) that complementary information is required for the FDA to take the decision to accept the BLA and initiate the review. |
| 2022-05-17 | Formycon AG | Regulatory United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) grants Marketing Authorization for FYB201, Formycon's Biosimilar for Lucentis®¹, to be Commercialized by Teva as ONGAVIA® formycon.com ↗ |
| 2022-05-17 | Formycon AG | Regulatory FYB201, Formycon's Biosimilar for Lucentis®¹, achieves Marketing Authorization in United Kingdom formycon.com ↗
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce, that today the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization (MA) in the United Kingdom (“UK”) for FYB201, a biosimilar to Lucentis® (ranibizumab). |
| 2022-05-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory United Kingdom first to grant licence for Teva’s ophthalmology biosimilar Ongavia (ranibizumab)▼ tevapharm.com ↗
Teva Pharmaceutical Industries Ltd welcomes the UK Medicines & Healthcare Regulatory Agency (MHRA) decision to grant a licence for Ongavia®, a biosimilar to Lucentis® (ranibizumab ), an eye injection. |
| 2022-02-15 | Xbrane Biopharma AB | Results Xbrane announces positive top-line results from the pivotal phase III equivalence trial for Xlucane™ – a biosimilar candidate to Lucentis® xbrane.com ↗
Further, the full 12-months data, as per Xbrane´s assessment, reveals no clinically meaningful differences between Xlucane™ and Lucentis®. |
| 2022-02-11 | Hoffmann-La Roche | Results New two-year data for Roche’s Vabysmo and Susvimo reinforce potential to maintain vision with fewer treatments for people with two leading causes of vision loss roche.com ↗
In the Archway study, Susvimo allowed 95% of people to go six months between treatments at two years – the fourth complete refill-exchange interval – while maintaining vision outcomes that were non-inferior to monthly ranibizumab injections. |
| 2022-02-10 | Genentech, Inc. | Results New Two-Year Data for Genentech’s Vabysmo and Susvimo Reinforce Potential to Maintain Vision With Fewer Treatments for People With Two Leading Causes of Vision Loss gene.com ↗
In the Archway study, Susvimo allowed 95% of people to go six months between treatments at two years – the fourth complete refill-exchange interval – while maintaining vision outcomes that were non-inferior to monthly ranibizumab injections. |
| 2021-10-22 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Susvimo, a first-of-its-kind therapeutic approach for neovascular or “wet” age-related macular degeneration (nAMD) roche.com ↗ |
| 2021-10-22 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD) gene.com ↗ |
| 2021-10-04 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics Group announces that the Biologics License Application (BLA) submitted by its joint venture Bioeq for its biosimilar Ranibizumab has been accepted for review by the U.S. Food and Drug Administration (FDA) polpharmabiologics.com ↗
This file acceptance represents the most recent milestone for Bioeq`s ranibizumab biosimilar program and compliments marketing authorization applications submitted to EMA in June and UK MHRA in July this year. |
| 2021-10-04 | Coherus Oncology, Inc. | Results Positive Results of Clinical Trial Comparing Coherus’ Ranibizumab Biosimilar Candidate CHS-201 to Reference Product Lucentis® (Ranibizumab) in the Treatment of Neovascular (Wet) Age-Related Macular Degeneration (nAMD) Presented at Retina Society Annual Scientific Meeting coherus.com ↗
The COLUMBUS-AMD study demonstrated the similarity of CHS-201 and reference product Lucentis in terms of clinical efficacy, safety, and immunogenicity in patients with newly diagnosed subfoveal nAMD. |
| 2021-10-01 | Formycon AG | Regulatory Formycon and Bioeq announce File Acceptance for FYB201, a biosimilar candidate to Lucentis® (ranibizumab) by the U.S. Food and Drug Administration (FDA) formycon.com ↗
the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for FYB201 |
| 2021-10-01 | Coherus Oncology, Inc. | Regulatory Coherus Announces BLA Filing for Lucentis® (ranibizumab) Biosimilar Candidate Accepted by FDA for Review coherus.com ↗
Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced the United States Food and Drug Administration (FDA) has accepted for review the 351(k) Biologics License Application (BLA) for CHS-201, a biosimilar candidate of reference product Lucentis® (ranibizumab). |
| 2021-09-30 | Xbrane Biopharma AB | Regulatory Xbrane Biopharma AB announces that partner STADA’s Marketing Authorization Application for ranibizumab is submitted and validated by European Medicines Agency xbrane.com ↗
Submission took place on September 9th and validation by EMA was communicated today. |
| 2021-09-20 | Biogen | Regulatory FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna) biogen.com ↗
BYOOVIZ™ is the first ophthalmology biosimilar approved in the United States. |
| 2021-08-06 | Polpharma Biologics S.A. | Regulatory Polpharma Biologics Group announces that its joint venture Bioeq has submitted a biologics license application (BLA) for biosimilar Ranibizumab to the U.S. Food and Drug Administration (FDA) polpharmabiologics.com ↗
Said submission represents the most recent milestone for Bioeq`s ranibizumab biosimilar program and compliments marketing authorization applications submitted to EMA and UK MHRA already in July this year. |
| 2021-08-05 | Formycon AG | Regulatory Formycon and Bioeq announce submission of the biologics license application (BLA) for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the U.S. Food and Drug Administration (FDA) formycon.com ↗ |
| 2021-06-29 | Formycon AG | Regulatory Formycon and Bioeq announce submission of the marketing authorization application for FYB201, a biosimilar candidate to Lucentis(R)1 (ranibizumab) to the European Medicines Agency (EMA) formycon.com ↗
Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG announce that the marketing authorization application (MAA) for FYB201, Formycon’s biosimilar candidate to Lucentis(R) (ranibizumab), has been submitted to the European Medicines Agency (EMA). |
| 2021-06-27 | Xbrane Biopharma AB | Results Xlucane™ meets the primary endpoint in the pivotal Phase III trial with Xlucane™ – regulatory submission in EU and US planned for second half of 2021 xbrane.com ↗
Xlucane™ met the primary endpoint demonstrating equivalent efficacy in change of BCVA (Best Corrected Visual Acuity) at week 8 of treatment compared to Lucentis®. |
| 2021-06-25 | Biogen | Regulatory Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Ranibizumab Biosimilar, BYOOVIZ™ biogen.com ↗
today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ™, a biosimilar candidate referencing Lucentis® 1 (ranibizumab), also known as SB11. |
| 2021-06-24 | Hoffmann-La Roche | Regulatory FDA accepts application for Roche’s Port Delivery System with ranibizumab (PDS) for treatment of neovascular or “wet” age-related macular degeneration (nAMD) roche.com ↗ |
| 2021-06-23 | Genentech, Inc. | Regulatory FDA Accepts Application for Genentech’s Port Delivery System With Ranibizumab (PDS) for Treatment of Wet Age-Related Macular Degeneration (AMD) gene.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for Port Delivery System with ranibizumab (PDS) for the treatment of wet, or neovascular, age-related macular degeneration (AMD). |
| 2020-11-18 | Biogen | Regulatory Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab) biogen.com ↗
the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Lucentis® 1 (ranibizumab). |
| 2020-10-06 | Biogen | Regulatory Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11, a Proposed Biosimilar Referencing Lucentis® (ranibizumab) biogen.com ↗
the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis ® (ranibizumab). |
| 2020-07-22 | Hoffmann-La Roche | Results Phase III data show Roche’s Port Delivery System with ranibizumab enabled over 98% of patients to go six months between treatments for neovascular age-related macular degeneration roche.com ↗
In Archway, 98.4% of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, a current standard of care. |
| 2020-07-22 | Genentech, Inc. | Results Phase III Data Show Port Delivery System With Ranibizumab Enabled Over 98% of Patients to Go Six Months Between Treatments for Neovascular Age-Related Macular Degeneration gene.com ↗
In Archway, 98.4% of PDS patients were able to go six months without needing additional treatment and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections, a current standard of care. |
| 2020-05-27 | Hoffmann-La Roche | Results Roche’s Port Delivery System with ranibizumab shows positive phase III results in neovascular age-related macular degeneration roche.com ↗
The Archway trial met its primary endpoint, demonstrating that patients with PDS who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab 0.5 mg injections. |
| 2020-05-26 | Genentech, Inc. | Results Port Delivery System With Ranibizumab Shows Positive Phase III Results in Neovascular Age-Related Macular Degeneration gene.com ↗
The Archway trial met its primary endpoint, demonstrating that patients with PDS who received refills every six months achieved visual acuity outcomes equivalent to those receiving monthly ranibizumab 0.5 mg injections. |
| 2020-02-04 | Formycon AG | Regulatory Formycon informs about the current Status of the BLA Review Process of the Lucentis®Biosimilar Candidate FYB201 formycon.com ↗
Therefore Bioeq has decided to withdraw its BLA application for the Lucentis® biosimilar candidate, provide the requested data and resubmit the application thereafter, which may delay the approval of the BLA. |
| 2019-08-20 | ThromboGenics | Results Oxurion NV Reports Topline Month 3 Results of Phase 2a Study Evaluating THR-317 (anti-PLGF), in Combination with Ranibizumab, for DME oxurion.com ↗
At Month 3, no improvement was observed in mean BCVA with the combination therapy when compared to ranibizumab monotherapy in the overall population. |
| 2019-07-26 | Novartis Pharmaceuticals | Regulatory Novartis receives positive CHMP opinion for Lucentis® treatment in preterm infants with retinopathy of prematurity (ROP), a disease causing visual impairment and blindness novartis.com ↗
Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Lucentis® (ranibizumab 10 mg/ml) for the treatment of preterm infants with retinopathy of prematurity (ROP). |
| 2019-01-18 | Xbrane Biopharma AB | Regulatory Xbrane Biopharma announces acceptance of initiation of Xlucane clinical trial in the US xbrane.com ↗
The Food and Drug Administration (FDA) and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab (Lucentis ® ) biosimilar candidate. |
| 2018-12-19 | Xbrane Biopharma AB | Regulatory Xbrane Biopharma has submitted the first application for start of Xlucane clinical trial xbrane.com ↗
Xbrane Biopharma has submitted its first national Clinical Trial Application (CTA) to the Food and Drug Administration (FDA) in the United States for the start of the Xplore trial for Xlucane, Xbrane Biopharma's lead candidate. |
| 2018-11-20 | Formycon AG | Results Formycon Releases Updates on Development Programs and Milestones formycon.com ↗
In addition to the achievement of the primary efficacy endpoint reported in May 2018, the study showed comparable results with regard to efficacy, safety and immunogenicity between the investigational medicinal product FYB201 and the reference medicinal product Lucentis®* (ranibizumab). |
| 2018-10-29 | Hoffmann-La Roche | Results New STAIRWAY study data shows potential for extended durability with Roche's faricimab in neovascular age-related macular degeneration (nAMD) roche.com ↗
Further phase II data for the Port Delivery System with ranibizumab (PDS), dosed every six months or longer, show vision and anatomical outcomes in nAMD that are comparable to ranibizumab dosed every four weeks |
| 2018-10-27 | Genentech, Inc. | Results New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD) gene.com ↗
Further Phase II data for the Port Delivery System with ranibizumab (PDS), dosed every six months or longer, show vision and anatomical outcomes in wet AMD are comparable to ranibizumab dosed every four weeks |
| 2018-10-04 | Xbrane Biopharma AB | Results Xbrane Biopharma announces results of in-vivo study showing equivalent tolerability and pharmacokinetic profile of Xlucane compared to Lucentis® xbrane.com ↗
An equivalent pharmacokinetic profile was observed in the Xlucane group compared to the Lucentis® group both measured in the serum as in the vitreous body. |
| 2018-09-22 | Novartis Pharmaceuticals | Results Novartis to file for new Lucentis® (ranibizumab) indication in retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness novartis.com ↗
In the Phase III RAINBOW study, despite marginally missing statistical significance for the primary endpoint of demonstrating superiority of Lucentis ® to laser surgery, Lucentis was shown to be an efficacious, safe and well-tolerated treatment for infants with ROP [1] |
| 2018-07-25 | Genentech, Inc. | Results Genentech Unveils Positive Phase II Results for the Port Delivery System with Ranibizumab (PDS), the First-Ever Eye Implant to Achieve Sustained Delivery of a Biologic Medicine to Treat People With Wet Age-Related Macular Degeneration (AMD) gene.com ↗
The majority of PDS patients went six months or longer between the implant of the device and the first required refill and patients in the high-dose PDS group achieved similar vision outcomes as monthly ranibizumab eye injections |
| 2018-07-19 | AbbVie | Results Allergan and Molecular Partners Announce Two Positive Phase 3 Clinical Trials for Abicipar pegol 8 and 12-week Regimens for the Treatment in Patients with Neovascular Age-Related Macular Degeneration abbvie.com ↗
In both studies abicipar demonstrated similar efficacy after 6 or 8 injections, compared to 13 ranibizumab injections in the first year of this study. |
| 2018-05-01 | Formycon AG | Results Formycon and Bioeq Achieve Important Milestone: Biosimilar Ranibizumab Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study formycon.com ↗
According to this, the primary endpoint has been achieved in the COLUMBUS-AMD trial, thus confirming comparable efficacy between FYB201 and the reference medicinal product Lucentis® in patients with neovascular age-related macular degeneration (nAMD). |
| 2018-05-01 | Formycon AG | Results Biosimilar Candidate FYB201 Shows Efficacy Comparable to the Reference Product in Phase III Study formycon.com ↗
The confidence interval lies within the pre-defined equivalence limits and demonstrates the comparable efficacy of FYB201 and Lucentis®. |
| 2018-03-21 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Lucentis (Ranibizumab Injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy gene.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.3 mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy. |
| 2017-04-18 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) 0.3 mg for the monthly treatment of withal forms of diabetic retinopathy. |
| 2017-04-17 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Lucentis (Ranibizumab Injection) for Diabetic Retinopathy, the Leading Cause of Blindness Among Working Age Adults in the United States gene.com ↗
today announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. |
| 2017-01-05 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Myopic Choroidal Neovascularization gene.com ↗
FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Myopic Choroidal Neovascularization |
| 2016-12-12 | Novartis Pharmaceuticals | Results Novartis provides update on pegpleranib Phase III clinical trial program in patients with neovascular age-related macular degeneration (nAMD or wet AMD) novartis.com ↗
Studies OPH1002 and OPH1003, sponsored by Ophthotech Corporation, did not meet the primary endpoint of superiority for the pegpleranib and ranibizumab combination therapy, measured as best corrected visual acuity (BCVA) in terms of additional letter gains over ranibizumab monotherapy. |
| 2016-12-07 | Novartis Pharmaceuticals | Regulatory Novartis' Lucentis® received EU approval in new indication - Lucentis the only treatment available for a wide range of CNV conditions novartis.com ↗
The European Commission approved Lucentis to treat patients for visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD) or secondary to pathologic myopia (PM) |
| 2016-10-14 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) Prefilled Syringe gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis® (ranibizumab injection) 0.5 mg prefilled syringe (PFS) as a new method of administering the medicine. |
| 2016-10-10 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Lucentis® (Ranibizumab Injection) Supplemental Biologics License Application for Myopic Choroidal Neovascularization gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Lucentis® (ranibizumab injection) for the treatment of myopic choroidal neovascularization (mCNV), a complication of severe near-sightedness that can lead to blindness. |
| 2015-03-08 | Formycon AG | Regulatory Formycon AG announces successful GMP inspection and the start of US FDA scientific advice procedure for its out-licensed biosimilar FYB201 formycon.com ↗
Formycon has now submitted the clinical study protocol and other documents to the U.S. Food and Drug Administration (FDA) to obtain also FDA’s expert advice before starting the pivotal global phase III study. |
| 2015-02-06 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Treatment of Diabetic Retinopathy in People with Diabetic Macular Edema gene.com ↗ |
| 2014-06-09 | iCo Therapeutics Inc. | Results iCo Therapeutics Announces Top-Line Primary Endpoint Data from iCo-007 Phase 2 iDEAL Study in Diabetic Macular Edema icotherapeutics.com ↗
Using the LOCF method, mean change in VA at eight months was approximately minus 11 letters (350 µg monotherapy), minus 21 letters (700 µg monotherapy), minus 14 letters (350 ug + laser arm) and minus 14 letters (350 µg + Lucentis). |
All press releases naming this drug 151 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 151 releases opens the full record — a long page | ||
Evidence & citations 22 cited values
Every value below carries the sentence it was read from. 478 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ranibizumab | “Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used...” NCT02457975 ↗468“PURPOSE: To investigate safety and evidence of efficacy of IBI-20089, an intravitreal, liquid, sustained drug delivery system formulated with triamcinolone acetonide (TA) in...” PMID 25376617 ↗ Nov 2014 “Dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) and Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) as needed group:” NCT01581151 ↗ “Recently, it's reported that intravitreal high dose Lucentis®(Ranibizumab) could benefit to both regression of the polyps and the relief of macular edema in PCV patients.” NCT02769169 ↗ “Anti-VEGFs including ranibizumab and biosimilars, aflibercept, faricimab, and brolucizumab will be used, as per the standard of care at participating sites.” NCT06985706 ↗ “A total of 442 patients with diabetic macular edema will be randomized 1:1 to be treated with either PRO-169 (bevacizumab) or Lucentis® (ranibizumab).” NCT05217680 ↗ “0.5 mg/0.05 mL solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial.” NCT01580020 ↗ “Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)” NCT00538538 ↗ “Comparing the efficacy and safety of BAT5906 and Ranibizumab (Lucentis®) in Patients With Neovascular Age-related Macular Degeneration” NCT05439629 ↗ “Effects of Intravitreal Ranibizumab for Macular Edema With Nonproliferative Diabetic Retinopathy” NCT02834663 ↗ “Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2.” NCT02262260 ↗ |
| Known as | (Lucentis, Ranibizumab (Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA) | “(Lucentis®, Ranibizumab (Novartis Pharma AG, Basel, Switzerland, and Genentech Inc., South San Francisco, CA, USA)” NCT04089605 ↗ |
| Known as | FYB201 | “The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related...” NCT02611778 ↗ |
| Known as | IVR | “Intravitreal ranibizumab (IVR) injection in patients with retinal dystrophy and macular cysts who have not responded to treatment with carbonic anhydrase inhibitors” NCT03763227 ↗ |
| Known as | Lucenti | “Ranibizumab (Lucenti®)” NCT02646670 ↗ |
| Known as | Lucentis | “OBJECTIVE: To examine the effects of intravitreal ranibizumab (Lucentis; Genentech, Inc., South San Francisco, CA) treatment on patient-reported vision-related function, as...” PMID 25148789 ↗ Aug 201466“Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used...” NCT02457975 ↗ “PURPOSE: To investigate safety and evidence of efficacy of IBI-20089, an intravitreal, liquid, sustained drug delivery system formulated with triamcinolone acetonide (TA) in...” PMID 25376617 ↗ Nov 2014 “The purpose of this study is to evaluate the effects of intravitreal Lucentis® (Ranibizumab) and investigate the anatomical and functional improvement following this treatment...” NCT00942864 ↗ “PURPOSE: To investigate the comparative efficacy of bevacizumab (Avastin) and ranibizumab (Lucentis; both Genentech, Inc, South San Francisco, CA) for diabetic macular edema...” PMID 26875003 ↗ Feb 2016 “Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials...” NCT00590694 ↗ “An emerging treatment modality for CME in RP is the use of intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF) such as bevacizumab (Avastin®) and...” NCT03763227 ↗ “To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy.” NCT01824043 ↗ “Dexamethasone intravitreal implant (DEX implant; OZURDEX, Allergan, Inc., Irvine, CA) and Ranibizumab (Lucentis, Genentech, Inc., South San Francisco, CA) as needed group:” NCT01581151 ↗ “Recently, it's reported that intravitreal high dose Lucentis®(Ranibizumab) could benefit to both regression of the polyps and the relief of macular edema in PCV patients.” NCT02769169 ↗ “Genetic factors of an individual patient may have an impact on Ranibizumab (Lucentis) treatment outcome in patients with Wet Age-Related Macular Degeneration (AMD).” NCT01676506 ↗ |
| Known as | Lucentis = ranibizumab | “Lucentis = ranibizumab” NCT00570193 ↗1“Lucentis (ranibizumab)” NCT00618644 ↗ |
| Known as | Lucentis the brand name of Ranibizumab | “Lucentis the brand name of Ranibizumab” NCT00813891 ↗ |
| Known as | Lucentis(ranibizumab), 3mg/0.3ml | “Lucentis(ranibizumab), 3mg/0.3ml” NCT01795209 ↗ |
| Known as | NDC # 50242-0080-01, Brand Name is Lucentis | “NDC # 50242-0080-01, Brand Name is Lucentis” NCT00387582 ↗ |
| Known as | PF582 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02121353 ↗ |
| Known as | Ranibizumab (Lucentis) | “Ranibizumab (Lucentis)” NCT02348359 ↗1“Ranibizumab (Lucentis)” NCT03585556 ↗ |
| Known as | Ranibizumab Ophthalmic | “Drug: Ranibizumab Ophthalmic” NCT03148132 ↗ |
| Known as | Ranibizumabe | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02005432 ↗ |
| Known as | RBZ | “This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective” NCT00407381 ↗1“Ranibizumab, RBZ (group B)” NCT06952452 ↗ |
| Known as | RFB002 | “Ranibizumab (RFB002)” NCT02259088 ↗ |
| Known as | rhuFab V2 | “This open-label study will pilot the use of an anti-VEGF therapy, ranibizumab (rhuFab V2) in 5 participants to investigate the potential efficacy as a treatment for retinal...” NCT00089765 ↗6“Ranibizumab (rhuFab V2, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema.” NCT00406796 ↗ “rhuFab V2 [ranibizumab] ( Lucentis )” NCT00403325 ↗ “rhuFab V2 (ranibizumab)” NCT00061594 ↗ “rhuFab V2 (ranibizumab)” NCT00251459 ↗ “rhuFab V2 (ranibizumab)” NCT00095433 ↗ “rhuFab V2 (ranibizumab)” NCT00090623 ↗ |
| Known as | Xlucane | “Xlucane (0.05 mL of 10 mg/mL ranibizumab) in the study eye monthly for 52 weeks.” NCT03805100 ↗ |
| Action | Inhibit | “neutralizes all active forms of vascular endothelial growth factor A” PMID 17021319 ↗ Oct 2006 |
| Modality | Monoclonal antibody | “ranibizumab--a recombinant, humanized, monoclonal antibody Fab” PMID 17021319 ↗ Oct 2006 |
| Route | Intravitreal | “monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg)” PMID 17021319 ↗ Oct 2006 |
| Target | VEGFA | “neutralizes all active forms of vascular endothelial growth factor A” PMID 17021319 ↗ Oct 2006 |