Drugs / Faricimab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed angioid streaks 1 milestone | |||||
| Filed | Japan (PMDA) | Vabysmo | angioid streaks | 2024-09-06 | “Chugai Files in Japan for Additional Indication of Vabysmo for Angioid Streaks, a Leading Cause of Vision Loss (Press release by Chugai issued on September 6, 2024)” chugai-pharm.co.jp ↗ |
| Filed central retinal vein occlusion with macular edema 1 milestone | |||||
| Filed | US (FDA) | Vabysmo | central retinal vein occlusion with macular edema | 2023-05-08 | “FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein...” gene.com ↗ “has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO).” roche.com ↗ |
| Filed diabetic macular edema 3 milestones | |||||
| Filed | US (FDA) | — | diabetic macular edema | 2021-07-28 | “FDA has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of wet, or neovascular, age-related macular degeneration (AMD)” gene.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab” gene.com ↗ |
| Filed | EU (EMA) | — | diabetic macular edema | 2021-07-28 | “The European Medicines Agency has also validated the faricimab Marketing Authorization Application for the treatment of wet AMD and DME.” gene.com ↗ “The European Medicines Agency has also validated the faricimab Marketing Authorisation Application submission in nAMD and DME.” roche.com ↗ |
| Filed | Japan (PMDA) | — | diabetic macular edema | 2021-06-10 | “New Drug Application in Japan for Faricimab, the First Bispecific Antibody in Ophthalmology for Diabetic Macular Edema and Neovascular Age-related Macular Degeneration” chugai-pharm.co.jp ↗ “filed a new drug application with the Ministry of Health, Labour and Welfare (MHLW) for faricimab” chugai-pharm.co.jp ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Vabysmo | — | 2022-09-15 | europa.eu ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07425522 | Apr 2026 → Nov 2028 expected | diabetic macular edema | Genentech, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT01941082 | Dec 2013 → Feb 2015 | macular degeneration | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06850922 | Jun 2022 → May 2026 | diabetic macular edema | Genentech, Inc. | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07093385 | Sep 2024 → Jun 2025 | age-related macular degeneration | University of Baghdad | Completed | No outcome recorded |
| Phase 2 | NCT05681884 | May 2023 → Feb 2026 | diabetic retinopathy | Greater Houston Retina Research | Completed | No outcome recorded |
| Phase 2 | NCT04597918 | Nov 2020 → Dec 2022 | diabetic macular edema | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT03038880 | Jan 2017 → Jan 2018 | age-related macular degeneration, choroidal neovascularization | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 2 | NCT02699450 | Apr 2016 → Sep 2017 | diabetic macular edema | Hoffmann-La Roche | Completed | Met primary |
| Phase 2 | NCT02484690 | Aug 2015 → Sep 2017 | choroidal neovascularization | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06572553 | Mar → Aug 2024 | age-related macular degeneration, diabetic macular edema, retinal vein occlusion | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 313 trials · 7 met primary · 1 missed | ||||||
| Phase 3 | NCT07461441 | Mar 2026 → Nov 2028 expected | age-related macular degeneration, choroidal neovascularization | Yeungnam University College of Medicine | Recruiting | No outcome recorded |
| Phase 3 | NCT06790784 | Aug 2025 → Aug 2031 expected | proliferative diabetic retinopathy | Jaeb Center for Health Research | Recruiting | No outcome recorded |
| Phase 3 | NCT06176352 | Mar 2024 → Sep 2025 | choroidal neovascularization | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT05904028 | Nov 2023 → Jul 2027 expected | wet macular degeneration | Jaeb Center for Health Research | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05569148 | Oct → Nov 2022 | diabetic macular edema, wet macular degeneration | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT04777201 | Apr 2021 → Sep 2024 | wet macular degeneration | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT04740905 | Mar 2021 → Jul 2022 | macular retinal edema, occlusion of tributary of retinal vein | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT04740931 | Mar 2021 → Aug 2022 | central retinal vein occlusion, macular retinal edema, partial retinal vein occlusion | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT04432831 | Aug 2020 → Oct 2023 | diabetic macular edema | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT03823300 | Mar 2019 → Oct 2020 | wet macular degeneration | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT03823287 | Feb 2019 → Oct 2020 | wet macular degeneration | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT03622593 | Oct 2018 → Oct 2020 | diabetic macular edema | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT03622580 | Sep 2018 → Oct 2020 | diabetic macular edema | Hoffmann-La Roche | Completed | Met primary |
| Phase 411 trials | ||||||
| Phase 4 | NCT07403825 | May 2026 → Oct 2028 expected | age-related macular degeneration | Biobizkaia Health Research Institute | Recruiting | No outcome recorded |
| Phase 4 | NCT07367282 | Apr 2026 → Apr 2028 expected | macular degeneration | Junyeop Lee | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07187804 | Sep 2025 → Sep 2028 expected | age-related macular degeneration, choroidal neovascularization, perifoveal exudative vascular anomalous complex | Kim's Eye Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06709339 | Aug 2025 → Aug 2028 expected | perifoveal exudative vascular anomalous complex | Association for Innovation and Biomedical Research on Light and Image | Recruiting | No outcome recorded |
| Phase 4 | NCT06795048 | Mar 2025 → Oct 2026 expected | wet macular degeneration | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06191094 | Jul 2024 → Dec 2026 expected | proliferative diabetic retinopathy | University of Colorado, Denver | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT05941715 | Jul 2023 → Sep 2024 | wet macular degeneration | Medical University of Graz | Completed | No outcome recorded |
| Phase 4 | NCT05610319 | May 2023 → Dec 2026 expected | diabetic macular edema | McMaster University | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06875245 | Mar 2023 → Apr 2025 overdue | wet macular degeneration | Faculty Hospital Kralovske Vinohrady | Recruiting | No outcome recorded |
| Phase 4 | NCT05610488 | Nov 2022 → Dec 2023 | diabetic macular edema | Vista Klinik | Unknown | No outcome recorded |
| Phase 4 | NCT05224102 | Feb 2022 → Jan 2027 expected | diabetic macular edema | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07520045 | Mar 2026 → Jun 2027 expected | diabetic macular edema | Osijek University Hospital | Recruiting | No outcome recorded |
| — | NCT07249216 | Jul 2025 → Jun 2029 expected | age-related macular degeneration | Singapore National Eye Centre | Recruiting | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT07484074 Comparator | Feb → Oct 2025 | diabetic macular edema, wet macular degeneration | Ollin Biosciences, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT07681167 Comparator | Dec 2026 → Aug 2029 expected | central serous chorioretinopathy | Singapore National Eye Centre | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06908876 Comparator | Apr 2025 → Dec 2026 expected | diabetic macular edema | Innovent Biologics Technology Limited (Shanghai R&D Center) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06985706 Comparator | May 2025 → Nov 2028 expected | diabetic macular edema | Belfast Health and Social Care Trust | Recruiting | No outcome recorded |
| Phase 3 | NCT05844982 Comparator | Nov 2023 → Dec 2029 expected | retinal vascular disorder, vision disorder | Jaeb Center for Health Research | Recruiting | No outcome recorded |
| Phase 4 | NCT07695298 Comparator | Jul 2026 → May 2028 expected | histoplasmosis retinitis | Cincinnati Eye Institute, Southwest Ohio | Recruiting | No outcome recorded |
| Phase 4 | NCT06742307 Comparator | Aug 2025 → Oct 2026 expected | choroidal neovascularization | Hospital Authority, Hong Kong | Recruiting | No outcome recorded |
| — | NCT06929507 Comparator | Mar 2025 → Mar 2026 overdue | diabetic macular edema, impaired renal function disease, wet macular degeneration | University Hospital, Alexandroupolis | Recruiting | No outcome recorded |
| — | NCT07144865 Comparator | Dec 2024 → Apr 2025 | proliferative diabetic retinopathy | Bojie Hu | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 69
| Date | Issuer | Release |
|---|---|---|
| 2026-10-01 | Hoffmann-La Roche | Results Roche presents new data at EURETINA, highlighting Vabysmo’s real-world effectiveness and safety across major retinal conditions roche.com ↗
In the nAMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment. |
| 2026-09-30 | Genentech, Inc. | Results Genentech Presents New Data at EURETINA, Highlighting Vabysmo’s Real-World Effectiveness and Safety Across Major Retinal Conditions gene.com ↗
In the wet AMD and DME cohorts of the study, vision and central subfield thickness (CST) improved in previously untreated eyes, while vision remained stable and CST improved in previously treated eyes, after 12 months of Vabysmo treatment. |
| 2026-09-24 | Ollin Biosciences, Inc. | Results Ollin Biosciences Announces Presentations and Symposium at EURETINA 2026 ollin.bio ↗
In the recently completed head-to-head Phase 1b JADE clinical study comparing OLN324 to faricimab (Vabysmo®), OLN324 demonstrated meaningfully faster and greater anatomic outcomes in both DME and wAMD versus faricimab as well as numerically greater vision gains. |
| 2026-09-08 | Quantum Biopharma | Results A Micro-Cap Biotech Just Cleared a Milestone Most Never Reach issuerdirect.com ↗
Roche Holding AG (OTCQX: RHHBY) released new two-year data from the phase IIIb/IV SALWEEN study of Vabysmo(R) (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society (“APVRS”) Congress in Australia. |
| 2026-08-28 | Hoffmann-La Roche | Results Roche’s Vabysmo demonstrates sustained two-year results in a difficult-to-treat form of neovascular age-related macular degeneration (nAMD) roche.com ↗
The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a severe sub-type of neovascular age-related macular degeneration (nAMD), the leading cause of vision loss in people over the age of 60. |
| 2026-04-30 | Hoffmann-La Roche | Results Roche to present extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 roche.com ↗
New data from the global VOYAGER study (NCT05476926) demonstrate that six months of treatment with Vabysmo dried the retina and improved retinal anatomy in real-world clinical practice. |
| 2026-04-29 | Genentech, Inc. | Results Genentech to Present Extensive Data Showcasing Its Industry-Leading Ophthalmology Portfolio at ARVO 2026 gene.com ↗
An important example is real-world data for wet AMD and DME showing that Vabysmo dries the retina and improves retinal anatomy in both treatment-naïve and previously treated settings. |
| 2026-03-31 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent's Partner Ollin Biosciences Announces Final Data from Randomized Head-to-Head Study of IBI324 Compared to Faricimab (Vabysmo) in Wet Age-Related Macular Degeneration and Diabetic Macular Edema innoventbio.com ↗
Final results released include favorable durability data for OLN324 compared to faricimab and new anatomic data showing faster, greater, and more durable control of wAMD pigment epithelial detachments (PEDs) with OLN324. |
| 2026-03-30 | Ollin Biosciences, Inc. | Results Ollin Biosciences Announces Final Data From Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo®) in Wet Age-Related Macular Degeneration and Diabetic Macular Edema ollin.bio ↗
Final results released today include favorable durability data for OLN324 compared to faricimab and new anatomic data showing faster, greater, and more durable control of wAMD pigment epithelial detachments (PEDs). |
| 2026-01-09 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent's Partner Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of IBI324 Compared to Faricimab (Vabysmo®) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration innoventbio.com ↗
Additionally, nearly 90% of OLN324 4mg treated patients achieved absence of DME at Week 12, defined as CST < 325 µm, as compared to 57% of faricimab patients. |
| 2026-01-08 | Ollin Biosciences, Inc. | Results Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of OLN324 Compared to Faricimab (Vabysmo®) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration ollin.bio ↗ |
| 2025-12-08 | Chugai Pharmaceutical | Results 48-Week Phase III Results Presented at Japanese Retina and Vitreous Society Meeting Show that Vabysmo Sustained Vision Improvements in Japanese Patients with Angioid Streaks chugai-pharm.co.jp ↗
These results showed that the improvement in visual acuity and drying of exudate obtained by 12 weeks was maintained until 48 weeks. |
| 2025-09-05 | Hoffmann-La Roche | Results New data for Roche's Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD) roche.com ↗
Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss. |
| 2025-09-04 | Genentech, Inc. | Results New Data for Genentech’s Vabysmo Reinforce Its Efficacy, Safety and Durability in Wet Age-Related Macular Degeneration (AMD) gene.com ↗
Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in wet age-related macular degeneration (AMD), a leading cause of vision loss. |
| 2025-05-19 | Chugai Pharmaceutical | Regulatory Chugai Obtains First Regulatory Approval in Japan for Vabysmo for Additional Indication of Angioid Streaks, a Cause of Vision Loss chugai-pharm.co.jp ↗
Vabysmo is the first approved drug in Japan for the treatment of this disease. |
| 2025-04-17 | Chugai Pharmaceutical | Results First Positive Phase III Results Presented at Japanese Ophthalmological Society Meeting Demonstrated that Vabysmo Sufficiently Improved Vision in Japanese Patients with Angioid Streaks chugai-pharm.co.jp ↗
The NIHONBASHI study results presented statistically significant and clinically meaningful vision improvement in angioid streaks associated with neovascularization |
| 2024-12-13 | Hoffmann-La Roche | Regulatory Roche’s Vabysmo prefilled syringe (PFS) approved in the EU for three retinal conditions that can cause blindness roche.com ↗ |
| 2024-10-18 | Hoffmann-La Roche | Results Roche’s Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study roche.com ↗
The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in people with diabetic macular edema (DME) treated with Vabysmo who identify as African American, Black, Hispanic and Latino1 |
| 2024-10-18 | Genentech, Inc. | Results Genentech’s Vabysmo Improved Vision in Underrepresented Populations With Diabetic Macular Edema (DME) in a First-Of-Its-Kind Study gene.com ↗ |
| 2024-09-06 | Chugai Pharmaceutical | Regulatory Chugai Files in Japan for Additional Indication of Vabysmo for Angioid Streaks, a Leading Cause of Vision Loss chugai-pharm.co.jp ↗ |
| 2024-07-30 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion (RVO) roche.com ↗ |
| 2024-07-17 | Hoffmann-La Roche | Results Roche’s Vabysmo showed extended durability, continued efficacy and a consistent safety profile in long-term diabetic macular edema (DME) study roche.com ↗
The study met all primary endpoints, showing that Vabysmo® (faricimab) was well tolerated in people with diabetic macular edema (DME) who received treatment for up to four years. |
| 2024-07-17 | Genentech, Inc. | Results Genentech’s Vabysmo Showed Extended Durability, Continued Efficacy and a Consistent Safety Profile in Long-Term Diabetic Macular Edema (DME) Study gene.com ↗
The study met all primary endpoints, showing that Vabysmo® (faricimab-svoa) was well tolerated in people with diabetic macular edema (DME) who received treatment for up to four years. |
| 2024-07-05 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss roche.com ↗ |
| 2024-07-04 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). |
| 2024-06-28 | Hoffmann-La Roche | Regulatory Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion (RVO) roche.com ↗ |
| 2024-04-15 | Chugai Pharmaceutical | Results Positive Phase III Results Showed Vabysmo Improved Vision for the First Time in Japanese in Angioid Streaks chugai-pharm.co.jp ↗
Vabysmo showed statistically significant and clinically meaningful vision improvement in angioid streaks associated with neovascularization |
| 2024-03-26 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Vabysmo, the Only Bispecific Antibody in the Ophthalmology Field, for Additional Indication of Macular Edema Associated with Retinal Vein Occlusion chugai-pharm.co.jp ↗ |
| 2024-02-01 | Hoffmann-La Roche | Results New long-term data for Roche’s Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO) roche.com ↗
Overall, results showed the vision improvements and reductions in retinal fluid achieved in the first 24 weeks of the studies were maintained up to 72 weeks. |
| 2024-01-31 | Genentech, Inc. | Results New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO) gene.com ↗
In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year. |
| 2023-10-27 | Hoffmann-La Roche | Regulatory [Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) roche.com ↗
Basel, 27 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (U.S. FDA) has approved Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). |
| 2023-10-26 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO) gene.com ↗ |
| 2023-10-10 | Hoffmann-La Roche | Results Roche’s Vabysmo maintained vision improvements with extended treatment intervals up to four months for people with retinal vein occlusion (RVO) in phase III studies roche.com ↗
Data showed that people treated with Vabysmo extended their treatment intervals up to every four months while maintaining the vision gains achieved in the first 24 weeks of the studies. |
| 2023-10-10 | Chugai Pharmaceutical | Results Roche Announces Updates on Retinal Vein Occlusion (RVO) for Vabysmo chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche issued a press release regarding long-term results of its two phase III clinical trials (BALATON study and COMINO study) for Vabysmo ® (faricimab) for retinal vein occlusion (RVO). |
| 2023-10-09 | Genentech, Inc. | Results Genentech’s Vabysmo Maintained Vision Improvements With Extended Treatment Intervals Up to Four Months for People With Retinal Vein Occlusion (RVO) in Phase III Trials gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline long-term results from the global Phase III BALATON and COMINO studies evaluating extended treatment intervals with Vabysmo® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO). |
| 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 ↗
Real-world data reinforce that first-line Vabysmo use improves outcomes and extends treatment intervals rapidly during the first four months for people with wet age-related macular degeneration (AMD) and DME |
| 2023-05-09 | Hoffmann-La Roche | Regulatory FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). |
| 2023-05-08 | Genentech, Inc. | Regulatory FDA Accepts Application for Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO) 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) has accepted the company’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). |
| 2023-04-27 | Chugai Pharmaceutical | Regulatory Chugai Files for Additional Indication of Vabysmo for Macular Edema Associated with Retinal Vein Occlusion in Japan chugai-pharm.co.jp ↗
“I’m very pleased that we have filed an additional indication for Vabysmo, the first bispecific antibody in the ophthalmology field for macular edema associated with RVO,” said Chugai’s President and CEO, Dr. Osamu Okuda. |
| 2023-04-25 | Hoffmann-La Roche | Results New Vabysmo data suggest greater retinal drying versus aflibercept in nAMD and DME roche.com ↗
Basel, 25 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that post-hoc data indicate treatment with Vabysmo® (faricimab) led to greater and faster drying of retinal fluid with fewer injections compared to aflibercept in neovascular or ‘wet’ age-related macular degeneration (nAMD). |
| 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). |
| 2023-04-13 | Hoffmann-La Roche | Results Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023 roche.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 nAMD. |
| 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. |
| 2023-02-10 | Hoffmann-La Roche | Results New phase III data show Roche’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO) roche.com ↗
The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. |
| 2023-02-09 | Genentech, Inc. | Results New Phase III Data Show Genentech’s Vabysmo Rapidly Improved Vision and Reduced Retinal Fluid in People With Retinal Vein Occlusion (RVO) gene.com ↗
The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. |
| 2022-10-27 | Hoffmann-La Roche | Results Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO) roche.com ↗
Vabysmo achieved its primary endpoint of non-inferiority to aflibercept in RVO in the BALATON and COMINO clinical trials |
| 2022-10-26 | Genentech, Inc. | Results Positive Topline Phase III Results Show Genentech’s Vabysmo Improved Vision for People Living With Retinal Vein Occlusion (RVO) gene.com ↗
Vabysmo achieved its primary endpoint of non-inferiority compared to aflibercept in RVO in the BALATON and COMINO clinical trials |
| 2022-07-14 | Hoffmann-La Roche | Results New two-year data confirm Roche’s Vabysmo improves vision with fewer treatments for people with neovascular age-related macular degeneration roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new two-year data from the TENAYA and LUCERNE studies that reinforce the long-term efficacy, safety and durability of Vabysmo® (faricimab) in neovascular or “wet” age-related macular degeneration (nAMD), a leading cause of vision loss. |
| 2022-07-14 | Genentech, Inc. | Results New Two-Year Data Confirm Genentech’s Vabysmo Improves Vision With Fewer Treatments for People With Wet-Age-Related Macular Degeneration gene.com ↗
Patients treated with Vabysmo received a median number of 10 injections over the two years versus 15 injections for those treated with aflibercept, potentially decreasing the number of injections |
| 2022-03-28 | Chugai Pharmaceutical | Regulatory Chugai Obtains Regulatory Approval for Vabysmo, the First Bispecific Antibody in Ophthalmology, for Neovascular Age-related Macular Degeneration and Diabetic Macular Edema chugai-pharm.co.jp ↗
Vabysmo, the first bispecific antibody in ophthalmology, has been approved for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) |
| 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 YOSEMITE and RHINE studies in diabetic macular edema, at least 60% of eligible Vabysmo patients could extend treatment to every four months at two years, compared to 50% at year one |
| 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 ↗
Furthermore, nearly 80% of people eligible for extended dosing with Vabysmo could be treated every three months or longer. |
| 2022-01-31 | Hoffmann-La Roche | Regulatory FDA approves Roche’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved Vabysmo™ (faricimab-svoa) for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). |
| 2022-01-28 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss 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) has approved Vabysmo ™ (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). |
| 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. |
| 2022-01-24 | Genentech, Inc. | Results The Lancet Publishes Studies Showing Genentech’s Faricimab Improved and Maintained Vision in Two Leading Causes of Vision Loss, Extending Time Between Treatments up to Four Months gene.com ↗
All four studies – which enrolled more than 3,000 people in total – met their primary endpoints, showing that patients treated with faricimab up to every four months achieved non-inferior vision gains compared to aflibercept, given every two months. |
| 2021-07-29 | Hoffmann-La Roche | Regulatory FDA accepts application for Roche’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA), under Priority Review, for faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). |
| 2021-07-28 | Genentech, Inc. | Regulatory FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) gene.com ↗
The FDA has also accepted the company’s submission for diabetic retinopathy. |
| 2021-06-11 | Chugai Pharmaceutical | Regulatory Chugai Files New Drug Application in Japan for Faricimab, the First Bispecific Antibody in Ophthalmology for Diabetic Macular Edema and Neovascular Age-related Macular Degeneration chugai-pharm.co.jp ↗
Chugai filed a regulatory application in Japan for faricimab as the first bispecific antibody in ophthalmology |
| 2021-02-12 | Hoffmann-La Roche | Results New phase III data show Roche’s faricimab is the first investigational injectable eye medicine to extend time between treatments up to four months in two leading causes of vision loss, potentially reducing treatment burden for patients roche.com ↗
The studies consistently showed that faricimab, given at intervals of up to four months, offered non-inferior vision gains compared to aflibercept, given every two months. |
| 2021-02-11 | Genentech, Inc. | Results New Phase III Data Show Genentech’s Faricimab Is the First Investigational Injectable Eye Medicine to Extend Time Between Treatments up to Four Months in Two Leading Causes of Vision Loss, Potentially Reducing Treatment Burden for Patients gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) today announced detailed results from four Phase III studies of its investigational bispecific antibody, faricimab, for the treatment of diabetic macular edema (DME) and neovascular or “wet” age-related macular degeneration (nAMD). |
| 2021-01-25 | Hoffmann-La Roche | Results Roche’s faricimab meets primary endpoint in two global phase III studies and shows potential to extend time between treatments up to 16 weeks for people with neovascular age-related macular degeneration roche.com ↗
Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks. |
| 2021-01-24 | Genentech, Inc. | Results Genentech’s Faricimab Meets Primary Endpoint in Two Global Phase III Studies and Shows Potential to Extend Time Between Treatments up to 16 Weeks for People With Neovascular Age-Related Macular Degeneration gene.com ↗
Both studies met their primary endpoint and showed that people receiving faricimab injections at fixed intervals of up to every 16 weeks achieved visual acuity outcomes that were non-inferior to those receiving aflibercept injections every eight weeks. |
| 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. |
| 2020-12-20 | Genentech, Inc. | Results Genentech’s Faricimab Meets Primary Endpoint and Shows Strong Durability Across Two Global Phase III Studies for Diabetic Macular Edema, a Leading Cause of Blindness gene.com ↗
Both studies met their primary endpoint and showed that faricimab given every eight weeks and at personalized dosing intervals of up to 16 weeks demonstrated non-inferior visual acuity gains compared to aflibercept given every eight weeks. |
| 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 ↗
At 52 weeks, faricimab patients dosed either every 16 weeks or every 12 weeks demonstrated sustained vision outcomes 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 ↗
At 52 weeks, faricimab patients dosed either every 16 weeks or every 12 weeks demonstrated sustained vision outcomes comparable to ranibizumab dosed every four weeks. |
| 2018-02-11 | Genentech, Inc. | Results Phase II Data Support Potential for Novel Anti-VEGF/Anti-Angiopoietin-2 Bispecific Antibody, RG7716, for People With Diabetic Macular Edema gene.com ↗
In people with vision loss from diabetic macular edema (DME), treatment with intravitreal RG7716 resulted in clinically meaningful and statistically significant improvements in visual acuity gains compared with ranibizumab alone. |
All press releases naming this drug 74 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 47 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Faricimab | “Anti-VEGFs including ranibizumab and biosimilars, aflibercept, faricimab, and brolucizumab will be used, as per the standard of care at participating sites.” NCT06985706 ↗43“patients will be administered the marketed drug Vabysmo®, whose active ingredient is Faricimab.” NCT07403825 ↗ |
| Known as | faricimab-svoa | “Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech.” NCT06572553 ↗ |
| Known as | RG7716 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297750 ↗ |
| Known as | RG77161 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297750 ↗ |
| Known as | RO6867461 | “The investigational medicinal product (IMP) for this study is faricimab (RO6867461), as per clinical practice.” NCT06709339 ↗ |
| Known as | Vabysmo | “This open-label, single-arm study will evaluate the efficacy, safety, and durability of Faricimab Injection [Vabysmo] 6 mg anti-VEGF IVT in Caucasian patients with symptomatic...” NCT06709339 ↗6“Faricimab (faricimab-svoa; Vabysmo), a bispecific antibody that inhibits both VEGF-A and Ang-2, was developed by Roche/Genentech.” NCT06572553 ↗ “patients will be administered the marketed drug Vabysmo®, whose active ingredient is Faricimab.” NCT07403825 ↗ “Faricimab Injection [Vabysmo]” NCT07695298 ↗ “Faricimab Injection [Vabysmo]” NCT07461441 ↗ “Faricimab Injection [Vabysmo]” NCT06742307 ↗ “Faricimab Injection [Vabysmo]” NCT07367282 ↗ |
| Known as | Y8ha1i28d3 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297750 ↗ |
| Action | Inhibit | “simultaneously and independently binds and neutralizes angiopoietin 2 (Ang-2) and vascular endothelial growth factor A (VEGF-A)” PMID 32729888 ↗ Sep 20202“Vascular endothelial growth factor A inhibitor” CHEMBL4297750 ↗ “Angiopoietin-2 inhibitor” CHEMBL4297750 ↗ |
| Modality | Monoclonal antibody | “Faricimab is a novel humanized bispecific Immunoglobulin G1 (IgG1) monoclonal antibody” NCT06709339 ↗ |
| Route | Intravitreal | “Single or multiple ascending dose by intravitreal injection” NCT01941082 ↗ |
| Target | ANGPT2 | “Angiopoietin-2 inhibitor” CHEMBL4297750 ↗ |
| Target | VEGFA | “Vascular endothelial growth factor A inhibitor” CHEMBL4297750 ↗ |