Viridian Therapeutics (NASDAQ:VRDN) announced details of its plans to initiate two Phase 3 clinical trials of its subcutaneous VRDN-003 product candidate for patients with active and chronic moderate-to-severe thyroid eye disease (TED), commencing in August.
Plans include two randomized, double-masked, placebo-controlled Phase 3 clinical trials, dubbed REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of subcutaneously administered VRDN-003 in patients with active and chronic TED.
In a statement, Tom Ciulla, CMO of Viridian, said that the current standard of care in TED requires eight intravenous doses which is a significant burden on patients. “Subcutaneous VRDN-003 could transform the treatment experience for patients with TED.”
The company expects topline data from both clinical trials to be available in the first half of 2026, with plans to file a BLA by the end of the year. Viridian aims to launch VRDN-003 with a commercially available injector pen.
