Roche reports positive 52-week data for eye disease drug vamikibart

Roche has released 52-week data from two Phase III clinical trials regarding its experimental drug, vamikibart, intended to treat uveitic macular edema (UME). The results, presented at the American Academy of Ophthalmology annual meeting, indicate that the treatment provides sustained improvements in vision and reduces retinal swelling.

Data from the MEERKAT and SANDCAT studies show that approximately two-thirds of eligible patients required no further injections following the initial treatment phase. While the MEERKAT study previously demonstrated statistical significance in visual acuity gains, the SANDCAT study's primary endpoint analysis showed a different result regarding statistical significance at week 16.

The U.S. Food and Drug Administration (FDA) has accepted Roche’s biologics application for the investigational eye injection, with a decision expected by July 2027. Regulatory applications for the drug have also been submitted in the European Union, China, and Japan.