Business
Ocular Therapeutix™ Reports Second Quarter 2024 Results
SOL-R AXPAXLI™ Repeat Dosing Study in Wet AMD Acceptable to FDA as Registrational Trial Enrollment in SOL-1 Continues to Accelerate and SOL-R Actively
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"SOL-R AXPAXLI™ Repeat Dosing Study in Wet AMD Acceptable to FDA as Registrational Trial Enrollment in SOL-1 Continues to Accelerate and SOL-R Actively Enrolling Patients Cash Balance of $459.7M as of June 30, 2024, Expected to Fund Operations into 2028 Ocular Will 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 reported financial results for the second quarter ended June 30, 2024 and provided recent business highlights, including an update on the Phase 3 AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI) wet age-related macular degeneration (wet AMD) program. “I am pleased to report that Ocular is making outstanding progress in 2024. Over the last six months, we have clarified our mission of becoming a leader in the treatment of retinal disease and thoughtfully assembled the team to deliver this mission. The exemplary work of our clinical team has allowed Ocular to accelerate enrollment in the SOL-1 superiority study of AXPAXLI in wet AMD and to swiftly design and initiate the SOL-R non-inferiority repeat dosing study. We are also pleased to report that the FDA has now confirmed that SOL-R is appropriate for use as our second registrational study,” said Pravin U. Dugel, MD, Executive Chairman, President and Chief Executive Officer of Ocular Therapeutix. “In June, we held a successful Investor Day that allowed us to put SOL-1 and SOL-R into context as complementary studies, addressing questions on durability and repeat dosing. We believe this could put us in a strong position to target a favorable label for AXPAXLI in wet AMD, potentially providing desired flexibility for physicians. The Investor Day also provided us with an opportunity to review the durable and consistent data from the HELIOS study in non-proliferative diabetic retinopathy (NPDR). With these HELIOS data, plus data from our two prior clinical trials in wet AMD, we remain extremely enthusiastic about our SOL-1 and SOL-R registrational studies.” Dr. Dugel concluded, “We believe this is just the beginning of a new ag...