Genentech: One-year Phase III data for vamikibart in uveitic macular edema
- MEERKAT and SANDCAT reported sustained improvements in best corrected visual acuity and reductions in central subfield thickness at 52 weeks with vamikibart.
- The FDA accepted Genentech’s BLA for vamikibart with an approval decision expected by July 2027; filings were also accepted in the EU, China and Japan.
- Dosing: intravitreal vamikibart 0.25 mg or 1 mg every four weeks up to 16 weeks, then PRN through week 52; about two‑thirds of eligible patients required no retreatment after 16 weeks.
- Vamikibart is an intravitreal anti‑IL‑6 monoclonal antibody being developed as a non‑steroid targeted therapy for UME and has orphan drug designation in the US and EU.
Phase III one-year findings
In the MEERKAT and SANDCAT trials, intravitreal vamikibart produced numerically higher proportions of patients with vision gains versus sham at 52 weeks and showed sustained improvements in average change from baseline in best corrected visual acuity (BCVA) and central subfield thickness (CST), a key measure of macular edema. The 16-week primary analysis was previously presented at AAO 2025.
Regulatory status
The U.S. Food and Drug Administration has accepted Genentech’s Biologics License Application for vamikibart in uveitic macular edema, with an approval decision expected by July 2027. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.
Trial design, dosing and durability
MEERKAT and SANDCAT are identical Phase III, global, randomized, double‑masked, sham‑controlled 52‑week trials. Patients received intravitreal vamikibart 0.25 mg or 1 mg or sham every four weeks for up to 16 weeks, followed by pro re nata treatment through week 52. Approximately two‑thirds of eligible patients required no retreatment after 16 weeks, and the majority of those who did required only one additional injection.
Safety and clinical context
Vamikibart maintained a favorable safety profile with a low incidence of treatment‑related ocular adverse events and intraocular inflammation. As an anti‑IL‑6 monoclonal antibody designed for intravitreal administration, it is being developed as a potential non‑steroid alternative to corticosteroids, which carry long‑term risks such as cataracts and elevated intraocular pressure.
Source: Genentech