Ocular Therapeutix™ Announces FDA Agreement to Amend Special Protocol Assessment (SPA) for Pivotal Clinical Trial of AXPAXLI™ in Wet AMD
Retrieved on:
Thursday, January 25, 2024
BEDFORD, Mass., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food and Drug Administration (FDA) has agreed to a Special Protocol Assessment (SPA) Agreement Modification for the Company’s pivotal Phase 3 SOL clinical trial of AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD).
Key Points:
- The SPA Agreement Modification enables the trial to include treatment-naïve wet AMD subjects with visual acuity of approximately 20/80 or better at the initial screening visit.
- The SPA Agreement Modification also allows the pivotal trial to move forward, evaluating AXPAXLI with a single optimized implant with a drug load of 450 µg of a more soluble form of axitinib.
- “With the changes reflected in the SPA Agreement Modification agreed to by the FDA, we believe we can accelerate the enrollment process for the SOL trial,” said Antony Mattessich, CEO of Ocular Therapeutix.
- “We have worked closely with the FDA to ensure that the SOL trial meets the agency’s updated guidance for wet AMD clinical trials, and we are eager to advance our engagement with clinical sites to enroll this trial under these new criteria."