Genentech, a member of the Roche Group, announced 2-year data from the Phase 3 Pagoda and Pavilion studies evaluating Susvimo (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), respectively. The results build on the primary one-year analyses of the Pagoda and Pavilion studies, with Susvimo demonstrating sustained efficacy over 2 years and safety consistent with the known safety profile for Susvimo in people with DME and DR, Genentech said in a press release. Detailed results were presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm.
 
Additionally, the FDA has accepted Genentech’s supplemental Biologics License Application (sBLA) for Susvimo for the treatment of DME and DR. The filing acceptance is based on the one-year results from the Phase 3 Pagoda and Pavilion studies, which showed that both studies met their primary endpoint. To date, Susvimo is approved in the Unites States for the treatment of wet, or neovascular, AMD.
 
According to the company, in the one-year primary data supporting the US sBLA in DME and DR, in Pagoda, people with DME who received Susvimo refilled every 6 months achieved non-inferior visual acuity gains compared with those receiving monthly 0.5-mg ranibizumab intravitreal injections. Approximately 95% of patients treated with Susvimo did not need additional treatment with supplemental injections during the primary analyses study period (64 weeks). 

In Pavilion, people with DR who received Susvimo refilled every 9 months achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared with participants under monthly clinical observation. No individuals treated with Susvimo needed additional treatment with supplemental injections during the primary analyses study period (52 weeks), compared to 60% in the control arm. 
 
In the 2-year Pagoda results presented at ASRS, people with DME receiving Susvimo refilled every 6 months through approximately 2 years continued to maintain improvements in vision gains seen at one year (9.8 eye chart letters), the company said. Approximately 95% of individuals did not need additional treatment with supplemental injections. Anatomically, Susvimo showed sustained improvements in central subfield thickness through week 112. The safety data were consistent with the known safety profile for Susvimo in people with DME, with no new safety signals observed. 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.
 
In the 2-year Pavilion results presented at ASRS, people with DR receiving Susvimo refilled every 9 months through approximately 2 years maintained DRSS improvements seen at one year, the company said. Specifically, at week 100, 80% of Susvimo participants achieved a two-step or greater improvement on the DRSS from pre-implant baseline, and participants who received Susvimo from week 64 either maintained or improved their DRSS score from pre-implant baseline.

According to the company, 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. In people treated with Susvimo, no cases of endophthalmitis were reported up to one year and the rate of endophthalmitis through week 100 was 0.8%. One participant with DR developed endophthalmitis and continued receiving treatment with Susvimo refills after successful resolution.