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Ocular Therapeutix™ To Close Enrollment This Week for SOL-R, its Second Registrational Trial Evaluating AXPAXLI™ in Wet Age-Related Macular Degeneration
Enrollment for SOL-R, the largest retinal TKI trial to date, supports randomization of at least 555 subjects SOL-1, Ocular’s first registrational trial in wet
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"Enrollment for SOL-R, the largest retinal TKI trial to date, supports randomization of at least 555 subjects SOL-1, Ocular’s first registrational trial in wet AMD, completed randomization in December 2024 and retention remains exceptional as the trial continues on track for top-line readout in 1Q 2026 These two complementary trials are intended to form the basis of an NDA submission of AXPAXLI in wet AMD BEDFORD, Mass., May 28, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), a fully-integrated biopharmaceutical company committed to redefining the retina experience, today announced that enrollment in the SOL-R registrational trial of its product candidate AXPAXLI™ in wet age-related macular degeneration (wet AMD) will close this week. “Completing enrollment in SOL-R – the largest retinal TKI trial to date – one year after the study was conceptualized reflects an extraordinary pace of execution and underscores our commitment to advancing innovation for patients with wet AMD,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer. “Together with SOL-1, these two complementary, FDA-aligned registrational trials have the potential to form a robust clinical foundation to support an AXPAXLI label with a distinct superiority claim and unprecedented 6- to 12-month dosing. With recruitment ending, we are focused on disciplined trial execution, and we are encouraged by the remarkable retention and adherence to protocol we’ve observed to date in both SOL-1 and SOL-R. We’re immensely grateful to the patients, investigators, and study sites whose partnership brings us one step closer to introducing a potential new standard of care in retinal disease.” Based on current and projected screening, loading, and randomization failure rates observed in SOL-R to date, Ocular believes it has enrolled enough subjects to ensure the Company’s target randomization of at least 555 subjects in SOL-R. Subjects for SOL-R are enrolled across approximately 100 sites in the U.S., Argentina, India, and Australia. SOL-R is Ocular’s second registrational study for AXPAXLI in wet AMD. The trial is evaluating the safety and efficacy of AXPAXLI dosed every 6 months versus aflibercept (2 mg) every 8 weeks. Subjects who have been screened and enrolled will now be treated with standard of care anti-VEGF treatment a...