Viridian Therapeutics announced that it has completed enrollment for the Phase III REVEAL-1 (NCT06812325) and REVEAL-2 (NCT06625398) trials evaluating VRDN-003 in patients with active and chronic thyroid eye disease (TED), respectively.

According to the company, the completion of enrollment marks a major milestone for VRDN-003, highlighting strong patient demand and setting up topline data in the first half of 2026 and a potential year-end Biologics License Application (BLA) submission.¹

Why are the REVEAL Trials Significant for the Future of TED Treatment?

“We are very pleased to continue Viridian’s track record of strong enrollment in TED clinical trials with over 330 TED patients in these two studies, bringing the total number of TED patients participating in Viridian’s clinical trials this year to nearly 500,” said Steve Mahoney, president, CEO, Viridian, in a press release. “Both REVEAL-1 and REVEAL-2 are larger than their veligrotug counterparts, and REVEAL-2 is the largest global Phase III clinical trial conducted in TED to date.”

REVEAL-1 Trial Enrollment and Benchmarks

• The randomized, double-masked, controlled REVEAL-1 trial is evaluating the safety and tolerability for VRDN-003 in 284 patients with TED.
• Patients will be randomly assigned to receive VRDN-003 every four weeks or every eight weeks in addition to placebo.
• The primary endpoint of the trial is incidence rate of treatment-emergent adverse events (TEAEs) through week 24.
• Key secondary endpoints include change from baseline in proptosis in the study eye at week 24 as measured by exophthalmometer and TEAE incidence rate through week 52.

REVEAL-2 Trial Enrollment and Benchmarks

• The randomized, double-masked, placebo-controlled REVEAL-2 trial is evaluating the efficacy, safety, and tolerability of VRDN-003 in 195 patients with TED.
• Patients will be randomly assigned to receive either VRDN-003 every four weeks, every eight weeks in addition to placebo, or placebo every four weeks.
• The primary endpoint of the trial is proptosis responder rate in the study eye.
• Key secondary endpoints include change from baseline in proptosis in the study eye, overall responder rate, Diplopia Responder Rate for participants with baseline Diplopia Score greater than 0, and Diplopia Resolution Rate for participants with baseline Diplopia Score greater than zero.^2,3

Trial Enrollment and Data Timelines

• Around 67% of patients in the REVEAL-1 trial were enrolled in the United States compared to 56% in REVEAL-2.
• Initial results from both trials are expected in the first half of 2026, with a BLA filing targeted for the end of that year.

VRDN-003 Profile

1. VRDN-003 is a subcutaneously administered, half-life extended anti-insulin-like growth factor-1 receptor antibody that shares its binding domain with veligrotug but was designed for greater durability.
2. Early findings showed a half-life of 40 to 50 days, four to five times longer than veligrotug.
3. Pharmacokinetic modeling indicates that dosing every four or eight weeks could maintain therapeutic exposure levels comparable to those tied to robust clinical activity.
4. Based on this profile, Viridian views VRDN-003 as a potential best-in-class therapy for TED.¹

“Taken together with the majority of patients in each study enrolling from the US, we believe these to be strong signals of patient demand for VRDN-003,” continued Mahoney, in the press release. “With veligrotug marching toward a BLA submission, and Breakthrough Therapy Designation supporting eligibility for Priority Review, we believe veligrotug and VRDN-003 have the potential to establish a new standard of care for patients. We would like to thank all the patients, caregivers, and clinical trial sites who are participating in our clinical studies.”

References

1. Viridian Therapeutics Announces Completion of Enrollment in both REVEAL Clinical Trials and Positive Portfolio Updates. Business Wire. September 15, 2025. Accessed September 15, 2025. https://www.businesswire.com/news/home/20250915997744/en/Viridian-Therapeutics-Announces-Completion-of-Enrollment-in-both-REVEAL-Clinical-Trials-and-Positive-Portfolio-Updates
2. A Safety and Tolerability Study of VRDN-003 in Participants With Thyroid Eye Disease (TED). Clinicaltrials.gov. Accessed September 15, 2025. https://clinicaltrials.gov/study/NCT06812325
3. An Efficacy, Safety, and Tolerability Study of VRDN-003 in Participants With Chronic Thyroid Eye Disease (TED) (REVEAL-2). Clinicaltrials.gov. Accessed September 15, 2025. https://clinicaltrials.gov/study/NCT06625398