Viridian Therapeutics updates VRDN-003 Phase 3 program in thyroid eye disease

Viridian Therapeutics reported details of its plans to initiate a phase 3 clinical trial program for its SC VRDN-003 product candidate for patients with moderate-to-severe thyroid eye disease, or TED. Viridian is planning to initiate two phase 3 clinical trials designed to evaluate the efficacy and safety of subcutaneously administered VRDN-003 in patients with active and chronic TED, named REVEAL-1 and REVEAL-2, respectively. These clinical trials are expected to initiate in August. The primary endpoint in each clinical trial will be proptosis responder rate, based on the achievement of at least 2mm improvement in proptosis from baseline at week 24, versus placebo. Viridian anticipates topline data for both clinical trials to be available in the first half of 2026 and to file a BLA by the end of 2026. The company plans to launch VRDN-003 with a commercially available autoinjector pen.