Ocular Therapeutix, Inc. 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 (DR), wet AMD and other retinal diseases.
DR 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. DR 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, CMO 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 potential pivotal design that is consistent with guidance from the FDA.
Subject to favorable interim data from the ongoing clinical trial and obtaining the necessary financing to fund the trial, the company plans to be prepared to initiate a Phase 3 pivotal trial for diabetic retinopathy as early as Q1 2024.
This is in addition to the company’s plan to be prepared for initiation of a pivotal program in wet AMD as early as Q3 of 2023, subject to obtaining the necessary financing.
About OTX-TKI
OTX-TKI is an investigational bioresorbable, hydrogel implant incorporating axitinib, a small molecule, multi-target, tyrosine kinase inhibitor with anti-angiogenic properties, being evaluated for the treatment of wet AMD, diabetic retinopathy and other retinal diseases.