Ocular Therapeutix, Inc. (NASDAQ: OCUL) shares cleared breakeven Monday, as the Bedford, Mass.-based biopharmaceutical announced that more than 300 patients have been randomized in the SOL-1 Phase 3 trial for AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), and the trial is expected to close randomization this week. This is the first registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD), which remains on track to report topline data in the fourth quarter of 2025.
“SOL-1 reaching target randomization in 2024 is a landmark event for Ocular. SOL-1 is an important trial for patients and the retina community as there is an urgent unmet need for durable therapies capable of maintaining visual acuity and improving long-term outcomes. Today’s milestone brings us one step closer to our goal of delivering the first wet AMD therapy potentially capable of being dosed as infrequently as every six to nine months. Achieving this progress reflects our positive engagement with the retina community, the dedication of our clinical sites, and the demand for a durable treatment option for wet AMD,” said CEO Pravin U. Dugel.
Ocular’s second registrational clinical trial, the SOL-R repeat dosing trial, has benefited from the recruitment momentum of SOL-1. Earlier this quarter, Ocular allowed investigators to enroll their patients directly into SOL-R, whereas patients were previously required to be a SOL-1 loading or randomization failure.
OCUL shares eked up 4.5 cents to $9.94.
