Ocular Therapeutix completes enrollment for phase 1 clinical trial of OTX-TKI

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Ocular Therapeutix, Inc. has completed 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.¹

“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 in the company’s press release. “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.

Reference:

1. Ocular Therapeutix™ Completes Enrollment of the HELIOS Clinical Trial of OTX-TKI for the Treatment of Diabetic Retinopathy Press release. Ocular Therapeutix, June 7, 2023. Accessed June 8, 2023. https://www.globenewswire.com/news-release/2023/06/07/2683695/0/en/Ocular-Therapeutix-Completes-Enrollment-of-the-HELIOS-Clinical-Trial-of-OTX-TKI-for-the-Treatment-of-Diabetic-Retinopathy.html