Core Insights - Roche announced five-year efficacy, safety, and durability data for Susvimo® (ranibizumab injection) in treating neovascular age-related macular degeneration (nAMD), showing sustained treatment effects with approximately 95% of patients requiring no supplemental treatment before each refill [1][2][7] Group 1: Study Results - The Phase III Portal study demonstrated that Susvimo maintained vision and retinal drying over five years, with best-corrected visual acuity (BCVA) showing a decline from 74.4 letters at baseline to 67.6 letters at five years in the Susvimo cohort, and from 76.3 letters to 68.6 letters in the IVT-Susvimo cohort [3][4] - Average central subfield thickness (CST) remained stable, with a reduction of 1.0 µm in the Susvimo cohort and 10.3 µm in the IVT-Susvimo cohort [3] Group 2: Treatment Comparison - Susvimo provides continuous delivery of ranibizumab via a refillable eye implant, contrasting with other treatments that may require monthly injections [5][10] - The Portal study cohort is the largest group of nAMD patients followed prospectively for five years, enhancing the reliability of the results [4][6] Group 3: Clinical Implications - The long-term results support Susvimo's potential to preserve vision in nAMD patients, addressing the challenges of frequent injections associated with traditional anti-VEGF treatments [2][7] - The study's findings may lead to improved real-world clinical outcomes for patients with nAMD, as continuous delivery could offer better vision preservation compared to standard treatments [2][6]

Core Viewpoint - Roche's Susvimo® has received FDA approval for the treatment of diabetic retinopathy, marking it as the first and only continuous delivery treatment that requires just one refill every nine months, potentially benefiting millions affected by this condition [1][2][7]. Group 1: Product Details - Susvimo is a refillable eye implant that delivers a customized formulation of ranibizumab, designed to maintain vision in diabetic retinopathy patients with only one treatment every nine months [3][9]. - The FDA's approval was based on positive results from the phase III Pavilion study, which demonstrated significant improvements in the Diabetic Retinopathy Severity Scale for patients using Susvimo compared to those receiving monthly anti-VEGF injections [2][6]. - The Port Delivery Platform allows for continuous delivery of medication directly into the eye, addressing retinal conditions that can lead to vision loss [3][9]. Group 2: Market Impact - The approval of Susvimo expands treatment options for diabetic retinopathy patients, providing a more durable solution compared to traditional monthly injections [2][7]. - Diabetic retinopathy affects nearly 10 million people in the US and over 100 million globally, highlighting a significant market opportunity for Roche [1][5]. - Susvimo is the third FDA-approved indication for the product, which is also approved for treating neovascular age-related macular degeneration and diabetic macular edema [7][13]. Group 3: Clinical Study Insights - The Pavilion study involved 174 participants with non-proliferative diabetic retinopathy, comparing the efficacy and safety of Susvimo with monthly clinical observation [6][8]. - Participants receiving Susvimo showed a reduction in the severity of eye damage without requiring supplemental treatment at one year [2][6]. - The primary endpoint of the study was a two-step improvement on the Early Treatment Diabetic Retinopathy Study-Diabetic Retinopathy Severity Scale at week 52 [6][8].