Viridian Therapeutics reported positive phase 3 REVEAL-2 topline results for elegrobart in chronic thyroid eye disease, with both Q4W and Q8W regimens meeting FDA and EMA primary endpoints and showing significant proptosis improvements versus placebo.
Written By: Farha Farheen, PharmD
Reviewed By: Pharmacally Editorial Team
Viridian Therapeutics announced positive topline results from the phase 3 REVEAL-2 trial (NCT06625398) on May 5, 2026, evaluating elegrobart a subcutaneously administered, half-life-extended monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R) in patients with chronic thyroid eye disease (TED).
The REVEAL-2 trial builds on previously announced positive results from the Phase 3 REVEAL-1 study, which evaluated elegrobart in patients with active thyroid eye disease and demonstrated significant improvements in key efficacy endpoints.
The study randomized 204 patients 1:1:1 to elegrobart every 4 weeks (Q4W; n=70), every 8 weeks (Q8W; n=68), or placebo (n=66). Both regimens met primary endpoints for U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) approval, showing statistically significant improvements over placebo at week 24 (p<0.0001).
For the FDA primary endpoint (proptosis responder rate), 50% of Q4W patients and 54% of Q8W patients responded, versus 15% on placebo. The EMA primary endpoint (overall responder rate) showed 47% and 54% responses in Q4W and Q8W arms, respectively, versus 15% on placebo. Mean proptosis reduction was -1.9 mm (Q4W) and -2.1 mm (Q8W), versus -0.5 mm with placebo.
Diplopia improvements included responder rates of 61% (Q4W; p=0.0118) and 55% (Q8W; p=0.0419) versus 38% on placebo. Complete diplopia resolution occurred in 44% (Q4W; p=0.0295) and 36% (Q8W; p=0.1304) versus 25% on placebo; p<0.025 was deemed statistically significant. Efficacy was consistent across baseline Clinical Activity Score (CAS) levels.
Elegrobart was well tolerated, with adverse events aligning with the anti-IGF-1R class profile and mostly mild. Placebo-adjusted hearing impairment rates were 4.1% (Q4W) and 8.8% (Q8W). No treatment-related serious adverse events occurred, and 91% of patients completed therapy.
REVEAL-2 is the second successful phase 3 trial for elegrobart after REVEAL-1 in active TED. Viridian remains on track for a Biologics License Application (BLA) submission to the FDA in Q1 2027.
Steve Mahoney, President and CEO of Viridian Therapeutics, stated, “These findings support elegrobart as a simplified at-home treatment option for chronic TED patients.”
John Mandeville, MD, PhD, oculoplastic surgeon at Ophthalmic Consultants of Boston and clinical associate at Massachusetts General Hospital, noted, “REVEAL-2 data suggest elegrobart may deliver clinically meaningful improvements with as few as three doses for chronic TED patients needing convenient options.”
Viridian confirmed its lead TED candidate, veligrotug, is under FDA Priority Review with a PDUFA date of June 30, 2026.
Reference
About the Writer
Farha Farheen, PharmD, is a pharmacy professional with a strong interest in pharmacovigilance and clinical research. She has completed her Doctor of Pharmacy (Pharm.D) along with her internship as a Clinical Pharmacist. She has hands-on experience in adverse drug reaction (ADR) reporting, safety data documentation, and pharmacovigilance workflows, and is proficient in using VigiFlow. She is also a patent holder for an antibacterial formulation enriched with bioactive substances, granted by the German Patent and Trademark Office.