Phase 3 REVEAL-2 data show that subcutaneous elegrobart significantly improved proptosis and diplopia outcomes versus placebo in chronic thyroid eye disease, meeting its primary endpoint at 24 weeks with both Q4W and Q8W dosing.
Positive topline results from the phase 3 REVEAL-2 trial suggest that elegrobart, an insulin-like growth factor-1 receptor (IGF-1R)-targeting monoclonal antibody developed by Viridian Therapeutics, met its primary endpoint in patients with chronic thyroid eye disease (TED), with both every-four-week (Q4W) and every-eight-week (Q8W) dosing regimens demonstrating statistically significant improvements versus placebo at 24 weeks.1
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Thyroid Eye Disease is a chronic autoimmune condition that can lead to proptosis, diplopia and long-term functional and quality-of-life impairment. While targeted therapies have expanded treatment options in recent years, chronic TED remains an area of ongoing unmet need, particularly for patients requiring effective treatment approaches that are practical over the longer term.2
The REVEAL-2 phase 3 trial enrolled 204 patients with chronic TED, randomized 1:1:1 to subcutaneous elegrobart Q4W (n=70), Q8W (n=68) or placebo (n=66). The study met its primary endpoint for both FDA and EMA criteria, with proptosis responder rates at week 24 of 50% in the Q4W arm and 54% in the Q8W arm, compared with 15% for placebo (both p<0.0001). Overall responder rates were 47% and 54% in the Q4W and Q8W groups, respectively, versus 15% with placebo.
Mean change in proptosis from baseline was −1.9 mm in the Q4W group and −2.1 mm in the Q8W group, compared with −0.5 mm in the placebo arm (both p<0.0001). Diplopia responder rates at week 24 were 61% with Q4W and 55% with Q8W, versus 38% with placebo, while complete diplopia resolution was observed in 44%, 36% and 25% of patients, respectively.
Elegrobart was generally well tolerated, with adverse events reported as consistent with the anti-IGF-1R class and predominantly mild. Ninety-one percent of treated patients completed the full treatment course, and no treatment-related serious adverse events were reported.
REVEAL-2 follows the previously positive phase 3 REVEAL-1 study in active TED. Viridian Therapeutics has indicated that a Biologics License Application for elegrobart remains on track for submission to the FDAÂ in Q1 2027. As development progresses, upcoming regulatory milestones and longer-term clinical experience will help clarify how subcutaneous anti-IGF-1R therapies may fit into the evolving management of both active and chronic TED.
References:
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Viridian Therapeutics Announces Positive Topline Results from Elegrobart Phase 3 REVEAL‑2 Clinical Trial in Chronic Thyroid Eye Disease. News. Vidian Therapeutics. Available at: https://investors.viridiantherapeutics.com/news/news-details/2026/Viridian-Therapeutics-Announces-Positive-Topline-Results-from-Elegrobart-Phase-3-REVEAL2-Clinical-Trial-in-Chronic-Thyroid-Eye-Disease/default.aspx (Accessed 6 May 2026).
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Tamhankar MA, Raza S, Brutsaert E, et al. The burden of illness in thyroid eye disease: current state of the evidence. Front Ophthalmol (Lausanne). 2025 Apr 17;5:1565762. doi: 10.3389/fopht.2025.1565762.
Cite: REVEAL-2 reports clinically meaningful responses across key TED endpoints. touchOPHTHALMOLOGY.com. 5 May 2026.
Editor: Nicola Cartridge, Head of Content
Disclosure: This article was created by the touchOPHTHALMOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-5.4) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
