Drugs / Faricimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Vabysmo | — | 2022-09-15 | europa.eu ↗ |
Trials 36 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 2 | NCT02484690 | Aug 2015 → Sep 2017 | choroidal neovascularization | Hoffmann-La Roche | Completed | No outcome recorded |
| 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 | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT04740931 | Mar 2021 → Aug 2022 | central retinal vein occlusion, macular retinal edema, partial retinal vein occlusion | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT04740905 | Mar 2021 → Jul 2022 | macular retinal edema, occlusion of tributary of retinal vein | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT04432831 | Aug 2020 → Oct 2023 | diabetic macular edema | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03823300 | Mar 2019 → Oct 2020 | wet macular degeneration | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03823287 | Feb 2019 → Oct 2020 | wet macular degeneration | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03622593 | Oct 2018 → Oct 2020 | diabetic macular edema | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03622580 | Sep 2018 → Oct 2020 | diabetic macular edema | Hoffmann-La Roche | Completed | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07484074 Comparator | Feb → Oct 2025 | diabetic macular edema, wet macular degeneration | Ollin Biosciences, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| 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 32 trials | ||||||
| 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 42 trials | ||||||
| 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 |
| Phase not applicable2 trials | ||||||
| — | 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 |
Press releases naming this drug 24 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-09-05 | Roche Global Development | New data for Roche's Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD) roche.com ↗ |
| 2024-12-13 | Roche Global Development | Roche’s Vabysmo prefilled syringe (PFS) approved in the EU for three retinal conditions that can cause blindness roche.com ↗ |
| 2024-10-18 | Roche Global Development | Roche’s Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study roche.com ↗ |
| 2024-07-30 | Roche Global Development | European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion (RVO) roche.com ↗ |
| 2024-07-17 | Roche Global Development | Roche’s Vabysmo showed extended durability, continued efficacy and a consistent safety profile in long-term diabetic macular edema (DME) study roche.com ↗ |
| 2024-07-05 | Roche Global Development | FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss roche.com ↗ |
| 2024-06-28 | Roche Global Development | Roche’s Vabysmo gets CHMP recommendation for third indication retinal vein occlusion (RVO) roche.com ↗ |
| 2024-02-01 | Roche Global Development | New long-term data for Roche’s Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO) roche.com ↗ |
| 2023-10-27 | Roche Global Development | [Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) roche.com ↗ |
| 2023-10-10 | Roche Global Development | 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 ↗ |
| 2023-07-20 | Roche Global Development | 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 ↗ |
| 2023-05-09 | Roche Global Development | FDA accepts application for Roche’s Vabysmo for the treatment of retinal vein occlusion (RVO) roche.com ↗ |
| 2023-04-25 | Roche Global Development | New Vabysmo data suggest greater retinal drying versus aflibercept in nAMD and DME roche.com ↗ |
| 2023-02-10 | Roche Global Development | New phase III data show Roche’s Vabysmo rapidly improved vision and reduced retinal fluid in people with retinal vein occlusion (RVO) roche.com ↗ |
| 2022-10-27 | Roche Global Development | Positive topline phase III results show Roche's Vabysmo improved vision for people living with retinal vein occlusion (RVO) roche.com ↗ |
| 2022-07-14 | Roche Global Development | New two-year data confirm Roche’s Vabysmo improves vision with fewer treatments for people with neovascular age-related macular degeneration roche.com ↗ |
| 2022-02-11 | Roche Global Development | 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 ↗ |
| 2022-01-31 | Roche Global Development | FDA approves Roche’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss roche.com ↗ |
| 2022-01-24 | Roche Global Development | 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 ↗ |
| 2021-07-29 | Roche Global Development | FDA accepts application for Roche’s faricimab for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) roche.com ↗ |
| 2021-02-12 | Roche Global Development | 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 ↗ |
| 2021-01-25 | Roche Global Development | 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 ↗ |
| 2020-12-21 | Roche Global Development | 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 ↗ |
| 2018-10-29 | Roche Global Development | New STAIRWAY study data shows potential for extended durability with Roche's faricimab in neovascular age-related macular degeneration (nAMD) roche.com ↗ |
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 ↗ “Drug: Faricimab” NCT07249216 ↗ |
| 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]” NCT06742307 ↗ “Faricimab Injection [Vabysmo]” NCT07367282 ↗ “Faricimab Injection [Vabysmo]” NCT07695298 ↗ “Faricimab Injection [Vabysmo]” NCT07461441 ↗ |
| 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 ↗ |