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Ocular Therapeutix™ Announces Late-Breaking Abstract of HELIOS Study to be Presented at 42nd ASRS Annual Scientific Meeting

Key Takeaway: Ocular Therapeutix announced that a late-breaking abstract from its Phase 1 HELIOS study of AXPAXLI, an intravitreal implant for non-proliferative diabetic retinopathy, will be presented at the 42nd ASRS Annual Scientific Meeting. The study aims to evaluate the safety and efficacy of AXPAXLI compared to a sham control. The presentation occurs on July 18th in Stockholm, Sweden. This development signals Ocular's ongoing commitment to advancing innovative therapies for eye diseases.

Market Sentiment Analysis

POSITIVE FACTORS

  • The acceptance of the late-breaking abstract at the ASRS Annual Scientific Meeting highlights the significance of the HELIOS study.
  • AXPAXLI's potential effectiveness for treating non-proliferative diabetic retinopathy is being explored in a clinical setting.
  • Ocular Therapeutix continues to innovate with its proprietary bioresorbable hydrogel technology.

Full Press Release Details

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 42nd 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.
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.
Ocular Therapeutix, Inc.
Vice President, Investor Relations

Frequently Asked Questions

What is the focus of Ocular Therapeutix, Inc.?

Ocular Therapeutix is dedicated to improving vision and quality of life through innovative eye therapies.

What is AXPAXLI used for?

AXPAXLI is an axitinib intravitreal implant aimed at treating non-proliferative diabetic retinopathy.

When will the HELIOS study results be presented?

The HELIOS study results will be presented on July 18th at the ASRS Annual Scientific Meeting.

What are the study's primary endpoints?

The primary endpoint is the frequency of treatment emergent adverse events (TEAEs).

What other products does Ocular have in development?

Ocular is developing PAXTRAVA for open-angle glaucoma and is in Phase 3 for wet AMD.

Last updated: Jul 10, 2024