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Opthea completes enrollment for sozinibercept (OPT-302) trials in pivotal Phase 3 program


The COAST and ShORe trials have a total of 1984 patients enrolled for the treatment of wet age-related macular degeneration.

Older person holding eye Image Credit: AdobeStock/Satjawat

Image Credit: AdobeStock/Satjawat

Clinical stage biopharmaceutical company Opthea Limited has announced enrollment completion for the COAST and ShORe trials in the pivotal Phase 3 program for treatment of patients with wet age-related macular degeneration (AMD).1 The announcement follows the enrollment completion of the COAST trial from earlier this year.2

“Today marks the achievement of a key milestone for the sozinibercept global Phase 3 clinical trial program that brings us closer to our goal of improving visual outcomes for patients with wet AMD,” said Arshad M Khanani, MD, MA, FASRS, chief medical advisor of Opthea, in a news release. “In a large Phase 2b clinical trial of 366 treatment-naïve wet AMD patients, sozinibercept demonstrated strong clinical evidence of superior visual outcomes in combination with ranibizumab. These data formed the basis for this large, global Phase 3 clinical program.”

The trials are designed to assess the safety and superior efficacy of sozinibercept (OPT-302) along with standard-of-care anti-VEGF-A therapies in the treatment of patients with wet AMD.1 Superiority in visual outcomes were demonstrated in Phase 2b of the program, according to the release.

Between the 2 multicenter, double-masked, randomized, sham controlled trials, 1984 patients were enrolled, with 998 patients in COAST and 986 in ShORe. Over the course of 2 years, COAST will assess the safety and tolerability of 2.0 mg sozinibercept administered intravitreally in addition to 2.0 mg aflibercept, with ShORe patients being administered 0.5 mg of ranibizumab instead of aflibercept. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity from baseline to week 52.1

“Sozinibercept is the only late-stage asset in development in over 15 years that is targeting better visual outcomes for wet AMD patients in combination with standard-of-care anti-VEGF-A therapies,” said Frederic Guerard, PharmD, chief executive officer of Opthea, in the release. “We are excited about the potential of sozinibercept to transform the current treatment paradigm, with pivotal 52-week topline data expected in mid-CY2025 to support a potential BLA submission.”

  1. Opthea completes enrollment in pivotal Phase 3 clinical program with sozinibercept in wet AMD. News release. Opthea Limited. May 28, 2024. Accessed May 29, 2024. https://ir.opthea.com/news-releases/news-release-details/opthea-completes-enrollment-pivotal-phase-3-clinical-program
  2. Joy J. Opthea Limited completes enrollment for 1 of 2 Phase 3 sozinibercept (OPT-302) trials. Optometry Times. February 19, 2024. Accessed May 29, 2024. https://www.optometrytimes.com/view/opthea-limited-completes-enrollment-for-1-of-2-phase-3-sozinibercept-opt-302-trials
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