4DMT Announces RMAT Designation Granted by FDA for 4D-150 for DME

Core Insights - 4D Molecular Therapeutics has received RMAT designation from the FDA for its product 4D-150, aimed at treating diabetic macular edema (DME) [1][2] - The RMAT designation highlights the potential of 4D-150 to meet significant unmet medical needs in DME, following a similar designation for wet age-related macular degeneration (wet AMD) [2] - 4D-150 is designed to provide multi-year sustained delivery of anti-VEGF therapies through a single intravitreal injection, reducing treatment burden for patients [3][5] Company Overview - 4D Molecular Therapeutics is a late-stage biotechnology company focused on developing durable and disease-targeted therapeutics [5] - The lead product candidate, 4D-150, targets blinding retinal vascular diseases, specifically wet AMD and DME, with ongoing Phase 3 clinical trials [5] - The company also has a second product candidate, 4D-710, aimed at cystic fibrosis treatment [5] Product Details - 4D-150 utilizes a customized intravitreal vector, R100, to deliver anti-VEGF therapies effectively [3] - The product aims to alleviate the treatment burden associated with frequent injections currently required for DME and wet AMD [3][4] - DME affects approximately one million individuals in the U.S., characterized by inflammation and swelling in the macula, leading to vision loss [4]