Press Release

Phase 1 HELIOS study evaluates AXPAXLI™ for non-proliferative diabetic retinopathy (NPDR)

BEDFORD, Mass., July 10, 2024 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”, the “Company”), a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy, and other diseases and conditions of the eye, today announced that a late-breaking abstract related to the Phase 1 HELIOS study of AXPAXLI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy (NPDR) was accepted for presentation at the 42^nd American Society of Retina Specialists (ASRS) Annual Scientific Meeting being held July 17-20 in Stockholm, Sweden.

Presentation at ASRS Annual Scientific Meeting:

• Title: Interim Safety and Efficacy Results From the Phase 1 HELIOS Trial of Sustained-release Axitinib Implant (OTX-TKI) for NPDR
  

Session Title: Diabetic Retinopathy Symposium 2        
Session Date/Time: Thursday, July 18th 10:47 – 10:51 AM CEST
Presenter: Dilsher S. Dhoot, MD

About the HELIOS study
The Phase 1 HELIOS trial is a multi-center, double-masked, randomized (2:1), parallel group study conducted in the U.S. The study was designed to evaluate the safety, tolerability, and efficacy of AXPAXLI compared to a sham control in subjects with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME). The primary endpoint of the study is frequency of treatment emergent adverse events (TEAEs). Secondary study endpoints include changes in the diabetic retinopathy severity score (DRSS), changes in best corrected visual acuity (BCVA) compared to baseline, changes in central subfield thickness (CSFT) compared to baseline, and the portion of subjects receiving rescue therapy.

About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR), and other diseases and conditions of the eye. AXPAXLI™ (axitinib intravitreal implant, also known as OTX-TKI), Ocular’s product candidate for retinal disease, is based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in a Phase 3 clinical trial for wet AMD. The clinical portfolio also includes PAXTRAVA™ (travoprost intracameral implant, also known as OTX-TIC), currently in a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension.

Ocular’s expertise in the formulation, development, and commercialization of innovative therapies of the eye and the ELUTYX platform supported the development and launch of its first commercial drug product, DEXTENZA^®, an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery and ocular itching associated with allergic conjunctivitis.

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The Ocular Therapeutix logo and DEXTENZA^® are registered trademarks of Ocular Therapeutix, Inc.  AXPAXLI™, PAXTRAVA™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc.

Investors & Media
Ocular Therapeutix, Inc.
Bill Slattery
Vice President, Investor Relations
bslattery@ocutx.com