Backbone Therapy for Retinal Vascular Diseases
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4DMT Announces Positive Long-Term Data from Phase 1/2 PRISM Clinical Trial in Wet AMD Supporting 4D-150's Potential as a Backbone Therapy with Consistent and Durable Benefit over Multiple Years
Globenewswireยท 2025-11-06 11:00
Core Insights - 4D Molecular Therapeutics announced positive interim data from the Phase 1/2 PRISM clinical trial for 4D-150, targeting wet age-related macular degeneration (wet AMD) with potential to transform treatment paradigms [1][8] Patient Cohort Overview - All patient cohorts maintained visual acuity and sustained control of retinal anatomy [2] - Significant reduction in treatment burden with fewer anti-VEGF injections over a period of up to 2 years [2][6] Treatment Burden Reduction - Phase 2b subgroup (recently diagnosed) showed a 94% reduction in supplemental injections through Year 1 and 92% through Year 1.5 [3] - Phase 2b cohort demonstrated an 83% reduction through Year 1 and 82% through Year 1.5 [3] - Phase 1/2a cohort exhibited an 83% reduction through Year 1 and 79% through Year 2 [3] Durability and Safety - 4D-150 showed consistent and durable benefits across all cohorts, maintaining visual acuity and reducing treatment burden for up to 2 years [4] - No new safety concerns or intraocular inflammation findings reported, with 99% of patients remaining off steroids after treatment [9] Clinical Trial Progress - Enrollment for the Phase 3 4FRONT-1 trial exceeded expectations, with over 200 patients randomized [4] - The global Phase 4FRONT-2 trial is on track for expected completion in the second half of 2026 [4] Product Overview - 4D-150 is designed for multi-year sustained delivery of anti-VEGF therapies with a single intravitreal injection, aiming to alleviate the burden of frequent injections for wet AMD patients [11][13] - The product is currently in Phase 3 development for wet AMD and diabetic macular edema [13] Market Context - Wet AMD is expected to affect over 4 million individuals in major markets within the next five years, with 200,000 new diagnoses annually in the U.S. [12]