Genentech’s Susvimo demonstrated sustained efficacy and safety over 2 years in patients with diabetic macular edema (DME) and diabetic retinopathy (DR), according to data from a pair of phase 3 studies unveiled at the American Society of Retina Specialists (ASRS) annual meeting in Stockholm, Sweden.
Susvimo is the first and only refillable eye implant that provides continuous delivery of a customized formulation of anti-VEGF agent ranibizumab via the Port Delivery Platform. The implant received US Food and Drug Administration (FDA) approval in 2021 to treat neovascular (“wet”) age-related macular degeneration (nAMD); however, Genentech voluntarily recalled the product in October 2022 due to quality-control problems with some implants. Earlier this month, Genentech announced that it would reintroduce Susvimo for nAMD patients, following FDA approval of component-level updates made to the ocular implant and refill needle.
The company reported that the FDA has accepted a supplemental Biologics License Application (sBLA) for Susvimo for the treatment of DME and DR, based on the 1-year results from the phase 3 Pagoda and Pavilion trials. Two-year data from Pagoda, reported at ASRS, showed that DME patients treated with Susvimo (refilled every 6 months) continued to maintain the improvement in vision gains seen at 1 year (9.8 eye chart letters). Approximately 95% of individuals did not need additional treatment with supplemental injections. In people treated with Susvimo, no cases of endophthalmitis were reported up to one year and the rate of endophthalmitis through week 112 was 0.7%, compared to 0.8% in the control arm. Refills of Susvimo were resumed in affected participants after successful resolution of endophthalmitis.
Two-year data from Pavilion reported at ASRS showed that patients with DR receiving Susvimo refilled every 9 months maintained improvements on Diabetic Retinopathy Severity Scale (DRSS) seen at 1 year. Specifically, at week 100, 80% of Susvimo participants achieved a 2-step or greater improvement on DRSS from preimplant baseline, and participants who received Susvimo from week 64 either maintained or improved their DRSS score from preimplant baseline. Approximately 98% of participants treated with Susvimo did not need additional treatment with supplemental injections. The safety data were consistent with the known safety profile for Susvimo in people with DR, with no new safety signals observed.
“These efficacy and safety results demonstrate that Susvimo can deliver robust vision outcomes over 2 years for people with diabetic eye diseases that can cause vision loss,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of global product development, said in a press release. “If approved by the FDA, Susvimo could bring a new treatment paradigm for diabetic eye diseases.”
