Ocular Therapeutix Progresses Phase 3 OTX-TKI Trial

Ocular Therapeutix has announced that over 300 patients have been randomized in the SOL-1 Phase 3 trial for OTX-TKI (AXPAXLI, axitinib intravitreal implant). This marks a critical milestone in the development of the first registrational trial for OTX-TKI as a treatment for wet age-related macular degeneration (wet AMD). Patient randomization is expected to close in early December 2024, with topline data anticipated in Q4 2025.

Addressing the Need for Durable Wet AMD Therapies

Dr. Pravin U. Dugel, Executive Chairman, President, and CEO of Ocular Therapeutix, emphasized the significance of this milestone:

“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,” Dugel said.

He added: “This milestone brings us one step closer to delivering the first wet AMD therapy potentially dosed as infrequently as every six to nine months. It reflects the positive engagement of the retina community, the dedication of clinical sites, and the demand for a long-lasting treatment option for wet AMD.”

Accelerating Progress with SOL-R

The momentum of the SOL-1 trial has positively impacted Ocular Therapeutix's second registrational trial, SOL-R, which focuses on repeat dosing. Earlier in Q4 2024, Ocular initiated direct enrollment for SOL-R, allowing investigators to enroll patients without requiring prior participation in SOL-1.

Dr. Dugel noted:
“With the enthusiasm from investigators and study site teams, we are accelerating the pace of SOL-R enrollment while staying focused on our mission to improve vision for patients.”

Ocular continues to activate new clinical trial sites globally to further expedite recruitment for SOL-R.

Overview of SOL-1 and SOL-R Studies

Ocular’s wet AMD registrational program for OTX-TKI comprises two complementary studies, SOL-1 and SOL-R, designed to:

• De-risk clinical outcomes.

• Align with regulatory standards.

• Provide a comprehensive evaluation of durability, repeatability, and dosing flexibility.

SOL-1 Trial:

• A superiority study conducted under a Special Protocol Agreement (SPA) with the FDA.

SOL-R Trial:

• A non-inferiority study to complement SOL-1 and support a New Drug Application (NDA).

• Approved by the FDA in a Type C response as the second adequate and well-controlled study for NDA submission.

Transforming Wet AMD Treatment

Ocular Therapeutix’s commitment to advancing OTX-TKI aims to address the challenges of current wet AMD therapies, offering a long-lasting solution with fewer treatments. As the trials progress, Ocular is positioned to deliver innovative therapies that could revolutionize the management of VEGF-mediated retinal diseases.