Enrollment complete in phase 3 trial of sozinibercept for wet AMD
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Opthea Limited has completed enrollment of its COAST phase 3 clinical trial, a study of sozinibercept in combination with Eylea for wet age-related macular degeneration, the company announced in a press release.
“Completion of patient enrollment in our first pivotal trial marks an important milestone in the development of sozinibercept for the treatment of wet AMD,” Frederic Guerard, PharmD, Opthea CEO, said in the release. “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, Genentech) compared to ranibizumab alone.”
Sozinibercept, also known as OPT-302, is a soluble VEGF receptor 3 that binds and neutralizes VEGF-C ad VEGF-D on their endogenous receptors, which can prevent blood vessel growth and vascular leakage, the release stated.
The multicenter, sham-controlled COAST trial will evaluate the safety and efficacy of intravitreal 2 mg sozinibercept in combination with 2 mg Eylea (aflibercept, Regeneron), an anti-VEGF-A treatment. Opthea also is conducting the concurrent ShORe trial, an investigation of sozinibercept in combination with 0.5 mg ranibizumab, for which enrollment should be complete by the second quarter of 2024.
The primary outcome of interest in both studies is mean change in best corrected visual acuity at week 52 for sozinibercept combination therapy vs. anti-VEGF-A alone.
“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,” Charles C. Wykoff, MD, PhD, director of research at Retina Consultants of Texas and chief investigator of the COAST trial, said in the release.
Topline results from both trials are expected by mid-2025, the company stated.
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