Ocular Therapeutix randomizes more than 300 patients in SOL-1 Phase 3 trial for OTX-TKI

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More than 300 patients have been randomized in the SOL-1 Phase 3 trial for OTX-TKI (AXPAXLI, axitinib intravitreal implant). The trial is expected to close randomization in early December 2024. This is the first registrational clinical trial of OTX-TKI in wet age-related macular degeneration (wet AMD) and is on track to report topline data in the fourth quarter of 2025.¹

Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix shared his thoughts on this milestone in the company’s press release1, saying, “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.”

Dugel continued, “Thanks to the excellent momentum from SOL-1, we recently ‘flipped the switch’, allowing active clinical sites to enroll patients directly into our second registrational study in wet AMD, SOL-R, further accelerating its pace of enrollment. Thanks to the palpable enthusiasm from the investigators and study site teams, we continue to make excellent progress with the enrollment of SOL-R, with a steady focus on our overall mission of improving vision for patients.”¹

The momentum of SOL-1 has benefitted Ocular’s second registrational clinical trial, the SOL-R repeat dosing trial. Earlier in Q4 of 2024, Ocular allowed investigators to enroll their patients directly into SOL-R. Previously, patients were required to be a SOL-1 loading or randomization failure. The SOL-R trial has seen an acceleration in recruitment and expected to be amplified by subjects enrolled but not ultimately randomized into SOL-1 because randomization targets are met. Ocular continues to activate additional clinical trial sites worldwide to further the speed of SOL-R enrollment.¹

About the SOL-1 and SOL-R studies

Ocular’s wet AMD registrational program for OTX-TKI is comprised of 2 complementary studies, designed with the intent of de-risking clinical outcomes, aligning with regulatory standards, enhancing each other’s enrollment, and providing a broad evaluation of durability, repeatability, and flexibility. SOL-1 is a superiority study being conducted under a Special Protocol Agreement (SPA) with the US Food and Drug Administration (FDA). In a written Type C response, the FDA agreed that the SOL-R non-inferiority study should be appropriate as a second adequate and well-controlled study to support a potential New Drug Application (NDA).¹

Reference:

1. Ocular Therapeutix™ Announces More Than 300 Subjects Randomized in SOL-1. Ocular Therapeutix, Inc. December 2, 2024. December 3, 2024. https://www.globenewswire.com/news-release/2024/12/02/2989687/0/en/Ocular-Therapeutix-Announces-More-Than-300-Subjects-Randomized-in-SOL-1.html