Core Viewpoint - Roche has received the EU CE mark for its Port Delivery Platform containing Susvimo, now known as Contivue® in the EU, which allows for continuous delivery of ranibizumab directly to the eye for the treatment of neovascular age-related macular degeneration (nAMD) [1][7]. Company Overview - Roche is focused on developing innovative therapies to combat vision loss, particularly through its advancements in continuous drug delivery systems [10][12]. - The company has a broad pipeline in ophthalmology, including treatments for various retinal diseases [11]. Product Details - Contivue is a refillable eye implant that allows for the delivery of a customized formulation of ranibizumab, with the potential for up to two treatments per year [6][7]. - The device includes four ancillary devices for filling, inserting, refilling, and removing the implant if necessary [1][6]. Clinical Data - Long-term data from the LADDER study indicates that patients treated with Contivue with Susvimo maintained good visual outcomes over seven years, with an average decline of only six letters in best-corrected visual acuity (BCVA) [3][4]. - Approximately 95% of patients maintained the durability of Contivue with Susvimo over the study period [3]. Market Impact - Susvimo is under review with the European Medicines Agency (EMA) and, once approved, will be the first continuous delivery treatment for nAMD, potentially impacting 1.7 million people in the European Union [7]. - The product is already approved in the US for nAMD, diabetic macular edema (DME), and diabetic retinopathy (DR) [9].

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].