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Ocular Therapeutix™ Completes Enrollment of the HELIOS Clinical Trial of OTX-TKI for the Treatment of Diabetic Retinopathy
Interim 6-month Data Expected in the First Quarter of 2024 BEDFORD, Mass., June 07, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a
About this update from Ocular Therapeutix, Inc.
[{"type":"text","content":"Interim 6-month Data Expected in the First Quarter of 2024\nBEDFORD, Mass., June 07, 2023 (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 completion of enrollment in the HELIOS clinical trial of OTX-TKI. Using Elutyx™ technology, OTX-TKI is the Company’s axitinib intravitreal implant that is being developed for the treatment of diabetic retinopathy, wet AMD and other retinal diseases. Diabetic retinopathy is a leading cause of vision loss in working-age adults, affecting approximately 140 million individuals around the world, including 8.4 million people in the United States alone. Diabetic retinopathy can lead to vision loss and even blindness due to high levels of blood sugar in the eyes that damage the blood vessels in the retina, the light-sensitive tissue at the back of the eye. “Millions of people suffer from diabetic retinopathy. Today, the current standard of care in non-proliferative stages is primarily ‘watchful waiting’, as frequent anti-VEGF injections and office visits pose a significant treatment burden primarily for the working-age population. Many patients frequently progress to more severe vision-destroying disease before they seek treatment, making diabetic retinopathy one of the leading causes of blindness among working-age adults in the U.S.,” said Rabia Gurses Ozden, MD, Chief Medical Officer of Ocular Therapeutix. “We believe the same attributes that make OTX-TKI a compelling product candidate for the treatment of wet AMD – the ease of use of an office-based injection and the potential for long-term durability that reduces the treatment burden and need for frequent, invasive injections – could establish OTX-TKI as the standard of care in the treatment of diabetic retinopathy.” The HELIOS Phase 1 trial is a multi-center, prospective, masked, 2:1 randomized, controlled U.S.-based trial in 21 subjects evaluating 600 µg OTX-TKI dosed in a single implant containing axitinib compared to a sham injection procedure. Interim 6-month data from the trial are expected in the first quarter of 2024. The Company has been in discussions with the FDA for the clinical development of OTX-TKI for the treatment of diabetic retinopathy and has a pot...