By: IPP Bureau
Last updated : October 22, 2025 7:25 pm
Vamikibart is the first targeted, non-steroid treatment designed to address the underlying inflammation driving UME
Roche announced positive results from two pivotal Phase III studies, MEERKAT and SANDCAT, evaluating the efficacy and safety of vamikibart, an investigational non-steroidal therapy for uveitic macular edema (UME). UME is characterized by the buildup of fluid in the macula due to uveitis—an inflammatory condition of the eye—and is a major cause of vision loss in people of working age.
Vamikibart is the first targeted, non-steroid treatment designed to address the underlying inflammation driving UME. Across both Phase III trials, treatment with vamikibart demonstrated rapid and clinically meaningful improvements in vision and macular thickness compared with a sham procedure that mimics intravitreal injections. The data were presented at the American Academy of Ophthalmology (AAO) Annual Meeting 2025 in Orlando, Florida, USA.
“The totality of data from these pivotal studies represents an important step toward addressing a clear unmet medical need for people living with uveitic macular edema,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche. “UME is a leading cause of vision loss and blindness in working-age adults. We look forward to discussing these promising data for vamikibart, a potential first-in-class treatment, with global regulatory authorities.”
Current UME treatments primarily rely on corticosteroids, which can cause serious side effects such as increased intraocular pressure, glaucoma, and cataract formation. “These new data suggest that vamikibart could offer a clinically meaningful, locally administered, non-steroid option for people with UME,” said Eric Suhler, MD, MPH, Professor of Ophthalmology at the Casey Eye Institute, Oregon Health & Science University, and study investigator.
“Across both studies, vamikibart showed robust improvements in visual and anatomical outcomes, with a low rate of treatment-related ocular adverse events.”
Vamikibart was generally well tolerated across both studies, with low rates of treatment-related ocular adverse events (AEs) and intraocular inflammation (IOI). No cases of retinal occlusive vasculitis were reported. The most common AEs (≥5 per cent) were conjunctival hemorrhage and increased intraocular pressure.