FDA approves Susvimo for age-related macular degeneration.- Genentech/Roche

Wet AMD is a potentially blinding condition that requires treatment with eye injections as often as once a month. Susvimo, previously called Port Delivery System with ranibizumab, is the first and only FDA-approved treatment for wet AMD that offers as few as two treatments per year.

The approval is based on positive results from the Phase III Archway study primary analysis, which showed wet AMD patients treated with Susvimo achieved and maintained vision gains equivalent to monthly ranibizumab injections – +0.2 and +0.5 eye chart letters from baseline, respectively – at weeks 36 and 40 of treatment. In addition, only 1.6% of Susvimo patients received supplemental ranibizumab treatment before their first refill, and more than 98% could go six months before their first refill.

In the Archway study, Susvimo was generally well-tolerated, with a favorable benefit-risk profile. However, the Susvimo implant has been associated with a three-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. In clinical trials, 2.0% of patients receiving a ranibizumab implant experienced at least one episode of endophthalmitis.