Shidlovski
Shares of Ocular Therapeutix (NASDAQ:OCUL) climbed on Friday after the eyecare specialist held its Investor Day yesterday, highlighting advances in its SOL-1 Phase 3 trial for its wet AMD candidate Axpaxli, among other updates.
With 60 trial sites and 151 subjects involved as of June 7, 2024, the Bedford, Massachusetts-based biotech said there is a “strong investigator engagement” for the pivotal study, which is expected to enroll about 300 treatment-naive Wet AMD patients.
The study conducted under a Special Protocol Assessment (SPA) with the FDA is designed to evaluate the Axpaxli eye implant against aflibercept, a wet AMD therapy marketed as Eylea by Regeneron (REGN) and Bayer (OTCPK:BAYZF) (OTCPK:BAYRY).
Citing the enrollment update, Piper Sandler analyst Biren Amin, who has an Overweight rating on OCUL, argued that SOL-1 “appears to be tracking ahead of its projected timelines of 1H ’25.” The analyst expects SOL-1 enrollments to be completed by Q4 2024.
However, SOL-1’s rapid pace of enrollment is not a surprise, said Dilsher Dhoot, MD, of California Retina Consultants. “We are recruiting treatment-naïve wet AMD patients with good vision, the largest de novo patient population we see, and there is no competing clinical trial for these patients,” he added.
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