The US Food and Drug Administration (FDA) has approved Genentech's Susvimo ocular implant as a treatment for diabetic macular edema (DME), the company said in a press release. According to the company, Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections.

Susvimo provides continuous delivery of a customized formulation of anti-VEGF agent ranibizumab via the port delivery platform. The implant was originally approved by the FDA for treatment of neovascular ("wet") age-related macular degeneration in 2021. 

One-year results from the phase 3 Pagoda study showed that patients with DME who received Susvimo refilled every 6 months achieved noninferior improvements in vision with Susvimo, gaining 9.6 eye chart letters, compared to patients receiving monthly 0.5 mg ranibizumab intravitreal injections, who gained 9.4 letters. 

Genentech said it will offer patient assistant programs for people prescribed Susvimo to help minimize barriers to access and reimbursement. More information is available at Genentech Access Solutions.