Viridian’s Phase 3 TED Trial Shows 54% Proptosis and 71% Diplopia Response
Viridian Therapeutics’ REVEAL-1 trial in thyroid eye disease reported 54% proptosis responder rate at Q4W versus 18% placebo (p<0.0001) and −2.33 mm exophthalmometry change versus −0.81 mm (p<0.0001). Diplopia responders reached 71% versus 32% placebo (p=0.0009) with 51% resolution, and BLA submission is set for Q1 2027 before Q2 2026 results.
1. REVEAL-1 Efficacy Findings
Viridian’s REVEAL-1 trial enrolled 132 thyroid eye disease patients randomized 1:1:1 to subcutaneous elegrobart every four weeks, every eight weeks or placebo. The Q4W arm achieved a 54% proptosis responder rate versus 18% placebo (p<0.0001) and a −2.33 mm mean exophthalmometry reduction versus −0.81 mm (p<0.0001); diplopia responder rate was 71% versus 32% placebo (p=0.0009) with 51% complete resolution.
2. Safety and Tolerability
Elegrobart was generally well tolerated, with most adverse events mild and consistent with the anti-IGF-1R class profile. Hearing impairment rates were low, with an 11.3% placebo-adjusted incidence in Q4W and 2.3% in Q8W; all events were tinnitus without associated hearing loss.
3. Regulatory Pathway and Next Steps
Viridian plans a BLA submission for elegrobart in Q1 2027 and anticipates a pivotal REVEAL-2 readout for chronic TED in Q2 2026. Separately, the veligrotug BLA under Priority Review carries a PDUFA date of June 30, 2026, positioning commercial infrastructure for a potential launch with limited incremental investment.