Key Takeaways Viridian’s Phase 3 REVEAL-1 trial met its primary endpoint, showing statistically significant and clinically meaningful reductions in proptosis with subcutaneous elegrobart in active thyroid eye disease The therapy demonstrated a favorable safety profile and the potential for convenient at-home administration Viridian plans to submit a BLA for elegrobart in Q1 2027 Viridian Therapeutics announced positive topline results from its phase 3 REVEAL-1 trial evaluating elegrobart, a subcutaneously delivered monoclonal antibody, in patients with active thyroid eye disease (TED). The study met its primary endpoint with high statistical significance, demonstrating strong efficacy in reducing proptosis, a hallmark symptom of TED. The results position elegrobart as a potential first-in-class, self-administered subcutaneous therapy for the disease, offering an alternative to the currently available intravenous treatment regimen. “REVEAL-1 represents the largest pivotal clinical trial conducted in active TED to date,” said Steve Mahoney, President and CEO of Viridian. “We observed robust proptosis responses with as few as three subcutaneous doses, along with clinically meaningful improvements in diplopia in the every-4-week dosing arm.” The REVEAL-1 trial enrolled 132 patients, randomized evenly into three groups: elegrobart administered every 4 weeks (Q4W), every 8 weeks (Q8W), and placebo. Key findings include: Primary endpoint met: Significant improvement in proptosis responder rate at 24 weeks in the Q4W group versus placebo Secondary endpoints achieved: Meaningful reductions in proptosis from baseline and improvements in diplopia, particularly in the Q4W cohort Flexible dosing: Efficacy observed across both Q4W and Q8W regimens, supporting multiple potential treatment schedules Elegrobart was generally well tolerated, with most adverse events classified as mild and consistent with the anti-IGF-1R drug class. Hearing-related events were infrequent and limited to tinnitus, with no associated hearing loss reported. Viridian plans to submit a Biologics License Application (BLA) for elegrobart to the FDA in the first quarter of 2027. Meanwhile, a second phase 3 trial, REVEAL-2, evaluating elegrobart in chronic TED is expected to report results in the second quarter of 2026. The company is also advancing veligrotug, another TED therapy candidate currently under FDA Priority Review. A decision is expected by June 30, 2026. Veligrotug has received both Breakthrough Therapy Designation and Priority Review status. Viridian indicated that its existing commercial infrastructure for veligrotug could support a future elegrobart launch with minimal additional investment, positioning the company to build a multi-therapy franchise in TED.