Opthea Limited completes enrollment for 1 of 2 Phase 3 sozinibercept (OPT-302) trials

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Enrollment has now been completed for Opthea Limited’s COAST Phase 3 clinical trial, which is investigating the use of sozinibercept (OPT-302) and aflibercept for the treatment of wet age-related macular degeneration (AMD). Sonzinibercept is a vascular endothelial growth factor (VEGF)-C’D inhibitor, while aflibercept is an anti-VEGF-A therapy, according to a news release.

Opthea Limited’s sozinibercept clinical program includes two Phase 3 pivotal trials, COAST and ShORe, with enrollment in ShORe slated to be completed in 2024’s second financial quarter.¹ The two trials are slated to run for 2 years, and are both defined as multicenter, randomized, parallel-group, sham-controlled, double-masked studies. The ShORe trial will evaluate the efficacy of ranibizumab in combination with sozinibercept.^2,3 Opthea Limited aiming to report topline results from both trials by mid-2025.¹

“Completion of patient enrollment in our first pivotal trial marks an important milestone in the development of sozinibercept for the treatment of wet AMD. We believe sozinibercept has the potential to provide superior clinical results, based on the strength of our Phase 2b trial, which demonstrated a statistically significant improvement in visual acuity for patients treated with sozinibercept combined with LUCENTIS® (ranibizumab) compared to ranibizumab alone,” said Opthea Limited’s Chief Executive Officer Frederic Guerard, PharmD, in the release. “We look forward to maintaining this positive momentum and completing enrollment in the ShORe pivotal trial in calendar Q2 2024, with a goal of communicating topline results for both trials by mid-2025.”

For both COAST and ShORe trial enrollment, those with active subfoveal CNV lesion or juxtafoveal CNV lesion with involvement that is secondary to AMD of a particular eye fall under the inclusion criteria. An ETDRS BCVA score must also be recorded between 60 and 25 (inclusive) letters in said eye. Those who would be excluded would be patients receiving any previous treatment for neovascular AMD, those with clinically significant ocular disorders other than neovascular AMD, and any current or past experiences with a social, psychological, or medical condition.^2,3

The COAST and ShORe trials evaluate the efficacy and safety of intravitreal sozinibercept in combination with aflibercept or ranibizumab in participants with AMD. These findings are to be compared with participants only receiving ranibizumab. The trial’s primary efficacy will be determined at week 52. The global trial is taking place in dozens of locations in several countries in North America, Europe, and Asia, among others.^2,3

“A tremendous thank you to the patients and families participating in our clinical program and also to our investigators and study coordinators. Your dedication and invaluable contributions have played a vital role in the development of this exciting new therapy,” said Charles C. Wykoff, MD, PhD, a board-certified medical and surgical retina specialist, director of research at Retina Consultants of Texas, and chief investigator of the Phase 3 COAST trial, in the release. “Sozinibercept, when used in combination with standard of care anti-VEGF-A treatment, has the potential to be the first therapy to achieve superior visual outcomes over anti-VEGF-A monotherapy and meaningfully improve outcomes for patients with wet AMD.”

References:

1. Opthea completes enrollment in first pivotal trial with sozinibercept. Opthea Limited. News Release. Published February 14, 2024. Accessed February 16, 2024. https://ir.opthea.com/news-releases/news-release-details/opthea-completes-enrollment-first-pivotal-trial-sozinibercept

2. OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD) (COAST). Opthea Limited. NCT04757636. Updated November 28, 2023. Accessed February 16, 2024. https://clinicaltrials.gov/study/NCT04757636?cond=Macular%20Degeneration&spons=Opthea%20Limited&rank=1

3. OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (ShORe). Opthea Limited. NCT04757610. Updated November 30, 2023. Accessed February 16, 2024. https://clinicaltrials.gov/study/NCT04757610?cond=Macular%20Degeneration&spons=Opthea%20Limited&rank=2