Vamikibart shows sustained one-year vision improvements in Phase III uveitic macular edema studies

Roche has reported new one-year Phase III data showing that investigational vamikibart maintained improvements in vision and reductions in macular swelling in adults with uveitic macular edema.

The findings come from the MEERKAT and SANDCAT studies and were presented at the 2026 American Academy of Ophthalmology Annual Meeting in New Orleans.

Vamikibart is an anti-IL-6 monoclonal antibody being developed as a targeted, non-steroid treatment for uveitic macular edema.

At week 52, both studies continued to show sustained clinical benefit compared with a sham procedure designed to mimic intravitreal injections.

A numerically higher proportion of patients receiving vamikibart achieved vision gains compared with sham treatment on the primary endpoint.

Improvements were also maintained across key secondary measures, including best corrected visual acuity and central subfield thickness.

Central subfield thickness is used to assess the degree of macular swelling caused by retinal fluid.

Roche said the treatment also showed a relatively low retreatment burden.

Around two-thirds of eligible patients did not require any additional treatment after week 16.

Among those who did need retreatment, most required only one additional injection.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, said the one-year findings confirm that the visual and anatomical improvements observed earlier in treatment were maintained through 52 weeks.

He added that the acceptance of regulatory submissions in several markets moves the company closer to potentially making a targeted non-steroid treatment available for the condition.

The U.S. Food and Drug Administration has accepted Roche’s Biologics License Application for vamikibart in uveitic macular edema.

A regulatory decision is expected by July 2027.

Applications have also been filed and accepted in the European Union, China and Japan.

If approved, Roche said vamikibart would become the first targeted non-steroid treatment for uveitic macular edema.

Nisha Acharya, MD, MS, Distinguished Professor of Ophthalmology at the University of California San Francisco, said current treatment often relies on off-label therapies or corticosteroids.

She noted that longer-term steroid use can be associated with complications including cataracts and increased intraocular pressure that may lead to glaucoma.

Vamikibart was generally well tolerated in the Phase III studies.

Roche reported a low incidence of treatment-related ocular adverse events and intraocular inflammation events.

Uveitic macular edema is a major cause of moderate to severe vision loss in people with uveitis and predominantly affects working-age adults.

Roche said approximately 20% of patients with the condition can progress to sustained blindness within three years of diagnosis.

The company is developing vamikibart to target the inflammatory pathway underlying the disease while potentially reducing reliance on corticosteroids.

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