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

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Ocular Therapeutix announced the acceptance of a late-breaking abstract related to their Phase 1 HELIOS study for presentation at the 42nd ASRS Annual Scientific Meeting. The study evaluates AXPAXLI, an axitinib intravitreal implant, for non-proliferative diabetic retinopathy (NPDR). The presentation, titled 'Interim Safety and Efficacy Results From the Phase 1 HELIOS Trial of Sustained-release Axitinib Implant (OTX-TKI) for NPDR', is scheduled for July 18, 2024, during the Diabetic Retinopathy Symposium 2 at 10:47 – 10:51 AM CEST. Dr. Dilsher S. Dhoot will present the interim findings emphasizing the potential of AXPAXLI in treating NPDR.

Positive
  • Acceptance of the HELIOS study abstract for presentation at a prestigious conference.
  • Focus on a promising treatment (AXPAXLI) for non-proliferative diabetic retinopathy.
  • Opportunity for increased visibility and validation at the ASRS Annual Scientific Meeting.
Negative
  • Only interim safety and efficacy results are available, indicating ongoing uncertainties.
  • Phase 1 status implies the treatment is still in early stages of clinical development.

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 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.

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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


FAQ

What is the HELIOS study by Ocular Therapeutix?

The HELIOS study is a Phase 1 clinical trial evaluating AXPAXLI, an axitinib intravitreal implant, for non-proliferative diabetic retinopathy (NPDR).

When and where will the HELIOS study results be presented?

The interim safety and efficacy results will be presented at the 42nd ASRS Annual Scientific Meeting on July 18, 2024, in Stockholm, Sweden.

Who will present the HELIOS study results?

Dr. Dilsher S. Dhoot will present the interim findings of the HELIOS study.

What is AXPAXLI?

AXPAXLI is an axitinib intravitreal implant being studied for the treatment of non-proliferative diabetic retinopathy (NPDR).

What company is behind the HELIOS study?

Ocular Therapeutix is the biopharmaceutical company conducting the HELIOS study.

Ocular Therapeutix, Inc.

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