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Ocular Therapeutix™ Announces FDA Feedback That SOL-R Trial is Appropriate as a Registrational Study in Wet AMD
Clear Regulatory Path for AXPAXLI™ in Wet AMD Through Ongoing SOL-1 and SOL-R Registration-Enabling Trials Ocular to Host a Q2 2024 Conference Call and
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"Clear Regulatory Path for AXPAXLI™ in Wet AMD Through Ongoing SOL-1 and SOL-R Registration-Enabling Trials Ocular to Host a Q2 2024 Conference Call and Webcast Today, August 7th, at 8:00 AM ET BEDFORD, Mass., Aug. 07, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to improving vision in the real world through the development and commercialization of innovative therapies for retinal diseases and other eye conditions, today announced that the Company has received a written response from the U.S. Food and Drug Administration (FDA) that the Phase 3 SOL-R clinical trial is appropriate for use as the Company’s second adequate and well controlled study of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet age-related macular degeneration (wet AMD). In a Type C written response, the FDA agreed that the SOL-R repeat dosing wet AMD study is appropriate as an adequate and well-controlled study in support of a potential New Drug Application (NDA) and product label. The FDA also noted that the use of one superiority study and one non-inferiority study is generally acceptable as the basis of an eventual NDA in wet AMD. Together, the Company intends the ongoing SOL-1 and SOL-R Phase 3 clinical trials to form the basis for the regulatory filing of AXPAXLI for wet AMD, assuming successful completion. Ocular recently announced that the first subjects have been enrolled in the SOL-R non-inferiority study evaluating repeat dosing of AXPAXLI. Enrollment in the SOL-1 superiority study evaluating a single AXPAXLI implant continues to accelerate, with subjects who do not meet randomization criteria having an opportunity to be enrolled into SOL-R. “We are very pleased that the FDA has found the SOL-R repeat dosing study to be acceptable as a registrational trial of AXPAXLI in wet AMD. This is an outstanding achievement for Ocular that clarifies the regulatory path for the two complementary Phase 3 studies in the AXPAXLI wet AMD program, SOL-1 and SOL-R,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “Our Phase 3 program is designed to align with the FDA’s guidance and provide commercially meaningful data. Thanks to the efforts of our clinical team, we have accel...