Core Viewpoint - Roche's Susvimo® has received FDA approval for the treatment of diabetic macular edema (DME), providing a new option for patients that requires fewer treatments compared to standard eye injections [1][2]. Group 1: Product Information - Susvimo is the first FDA-approved treatment for DME that maintains vision with fewer treatments, specifically with as few as two treatments per year [6][7]. - The FDA's approval was based on positive results from the phase III Pagoda study, which demonstrated that Susvimo provided sustained vision improvements compared to monthly injections of ranibizumab [2][5]. - In the Pagoda study, patients receiving Susvimo every six months achieved a vision improvement of 9.6 letters on the eye chart, comparable to 9.4 letters for those receiving monthly injections [2][5]. Group 2: Market Context - DME affects over 29 million adults globally and is a leading cause of vision loss in people with diabetes [1][4]. - The prevalence of DME is expected to rise as diabetes rates increase, highlighting the growing need for effective treatment options [4]. Group 3: Company Strategy - Roche is committed to innovation in ophthalmology, focusing on therapies that address leading causes of vision loss [3][8]. - The company has the broadest retina pipeline in ophthalmology, which includes various innovative treatments targeting multiple vision-threatening conditions [9][10].
FDA approves Roche's Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness