India Pharma Outlook Team | Thursday, 23 October 2025
Roche revealed promising results from two pivotal Phase III trials, MEERKAT and SANDCAT, assessing vamikibart, an investigational non-steroidal medication for uveitic macular edema (UME).
UME is attributable to inflammation and an accumulation of fluid in the macula and is a primary cause of vision loss and blindness among working-age adults.
According to Roche, vamikibart is the first targeted, non-steroidal treatment intended to target the inflammation that causes UME.
In both studies, participants taking vamikibart had rapid and clinically meaningful improvement in vision and macular thickness relative to those who received a sham treatment that mimicked the procedure for intravitreal injections. The results were presented at the 2025 Annual Meeting of the American Academy of Ophthalmology (AAO) in Orlando, Florida, USA.
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Dr. Levi Garraway, Roche Chief Medical Officer and Head of Global Product Development said that: “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.” Garraway also stated that Roche looks forward to discussing data with regulatory authors as it prepares to progress vamikibart forward for possible approval for potential first-in-class treatment.
Presently, UME treatments most often include corticosteroids which may carry side effects like glaucoma, cataract, and elevation of intraocular pressure. Study investigator Dr. Eric Suhler said that vamikibart might provide a significant, locally delivered, non-steroidal alternative with a robust efficacy and safety profile.
In both parts of the study, vamikibart was well tolerated in patients with low rates of ocular adverse events and no cases of retinal occlusive vasculitis. Most adverse events were conjunctival hemorrhage and increased intraocular pressure.
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