Drugs / Vamikibart
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | diabetic macular edema | 2026-10-10 | “Regulatory submissions have also been filed and accepted in the European Union, China and Japan.” gene.com ↗ |
| Filed | EU (EMA) | — | diabetic macular edema | 2026-10-10 | “Regulatory submissions have also been filed and accepted in the European Union, China and Japan.” gene.com ↗ |
| Filed | US (FDA) | — | diabetic macular edema | 2026-10-10 | “the U.S. Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) for vamikibart for the treatment of UME.” roche.com ↗ |
| Filed | Japan (PMDA) | — | diabetic macular edema | 2026-08-25 | “it has filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for vamikibart” chugai-pharm.co.jp ↗ “Regulatory submissions have also been filed and accepted in the European Union, China and Japan.” gene.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06771271 | Jul 2019 → Nov 2023 | diabetic macular edema, macular retinal edema | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02842541 | Sep 2016 → Oct 2017 | diabetic macular edema | Eleven Biotherapeutics | Withdrawn | No outcome recorded |
| Phase 22 trials · 2 missed | ||||||
| Phase 2 | NCT05151731 | Dec 2021 → Nov 2024 | diabetic macular edema | Hoffmann-La Roche | Completed | Missed primary |
| Phase 2 | NCT05151744 | Dec 2021 → Apr 2024 | diabetic macular edema | Hoffmann-La Roche | Completed | Missed primary |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05642325 | Mar 2023 → May 2025 | macular retinal edema | Hoffmann-La Roche | Completed | Missed primary |
| Phase 3 | NCT05642312 | Jan 2023 → Dec 2024 | macular retinal edema | Hoffmann-La Roche | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-10-10 | Hoffmann-La Roche | Results Roche presents new Phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss roche.com ↗
In the MEERKAT and SANDCAT studies, vamikibart demonstrated sustained improvements in vision and reductions in macular thickness in patients with UME at 52 weeks1,2 |
| 2026-10-10 | Genentech, Inc. | Results Genentech Presents New Phase III One-Year Data for Vamikibart in Uveitic Macular Edema (UME), a Serious Cause of Vision Loss gene.com ↗
Across both studies, data continue to support the potential for rapid and sustained improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment. |
| 2026-08-25 | Chugai Pharmaceutical | Regulatory Vamikibart Filed for Regulatory Approval in Japan for Uveitic Macular Edema Associated with Non-Infectious Uveitis chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has filed a regulatory application with Japan’s Ministry of Health, Labour and Welfare for vamikibart, an anti-IL-6 monoclonal antibody, for the treatment of uveitic macular edema (UME) associated with non-infectious uveitis. |
| 2025-10-17 | Hoffmann-La Roche | Results Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss roche.com ↗
Across both studies, the primary and secondary endpoint data support the potential for rapid improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment. |
| 2025-10-17 | Genentech, Inc. | Results Genentech Presents New Phase III Pivotal Data for Vamikibart in Uveitic Macular Edema (UME), a Serious Cause of Vision Loss gene.com ↗
Across both studies, the primary and secondary endpoint data support the potential for rapid improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment. |
| 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 ↗
Additionally, phase I data for an investigational anti-interleukin-6 (IL-6) treatment in uveitic macular edema (UME), to be presented for the first time, suggest the monoclonal antibody may improve visual acuity in patients with UME. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-10-10 | Hoffmann-La Roche | Roche presents new Phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss roche.com ↗ |
| 2026-10-10 | Genentech, Inc. | Genentech Presents New Phase III One-Year Data for Vamikibart in Uveitic Macular Edema (UME), a Serious Cause of Vision Loss gene.com ↗ |
| 2026-08-25 | Chugai Pharmaceutical | Vamikibart Filed for Regulatory Approval in Japan for Uveitic Macular Edema Associated with Non-Infectious Uveitis chugai-pharm.co.jp ↗ |
| 2025-10-17 | Hoffmann-La Roche | Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss roche.com ↗ |
| 2025-10-17 | Genentech, Inc. | Genentech Presents New Phase III Pivotal Data for Vamikibart in Uveitic Macular Edema (UME), a Serious Cause of Vision Loss gene.com ↗ |
| 2023-04-13 | Hoffmann-La Roche | Roche data highlights strength of ophthalmology portfolio and commitment to advancing eye care at ARVO 2023 roche.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vamikibart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05642312 ↗ |
| Known as | EBI-031 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02842541 ↗ |
| Known as | RG-6179 | ChEMBL registry synonym — accepted as the source's own label CHEMBL5315020 ↗ |
| Known as | RO7200220 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06771271 ↗ |
| Action | Inhibit | “Interleukin-6 (IL-6) Inhibitor” NCT02842541 ↗ |
| Modality | Monoclonal antibody | — CHEMBL5315020 ↗ |
| Route | Intravitreal | “given as an intravitreal injection” NCT02842541 ↗ |
| Target | IL6 | “Interleukin-6 (IL-6) Inhibitor” NCT02842541 ↗ |