Two phase 3 clinical trials have completed enrollment and will evaluate sozinibercept for patients with wet age-related macular degeneration (AMD).
Nearly 2,000 patients were enrolled across the COAST (n=998) and ShORe (n=968) trials, which will assess the safety and efficacy of sozinibercept in combination with standard of care anti-vascular endothelial growth factor (VEGF) A therapies versus standard of care alone.
The multicenter, double-masked, randomized, sham-controlled trials combine sozinibercept with aflibercept 2.0 mg (COAST) or ranibizumab 0.5 mg (ShORe). The primary end point is mean change in best correct visual acuity from baseline to week 52. Safety and tolerability will be assessed over a 2-year period.
“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 a press release. “We are excited about the potential of sozinibercept to transform the current treatment paradigm, with pivotal 52-week topline data expected in mid-2025 to support a potential [Biologics License Application] submission.”
A prior phase 2b trial found that sozinibercept in combination with ranibizumab resulted in a statistically superior gain in visual acuity at 24 weeks compared with ranibizumab alone. The trial included 366 patients with treatment-naïve wet AMD.
Reference
Opthea completes enrollment in pivotal phase 3 clinical program with sozinibercept in wet AMD. GlobeNewswire. May 28, 2024. Accessed May 28, 2024. https://www.globenewswire.com/en/news-release/2024/05/28/2888925/0/en/Opthea-Completes-Enrollment-in-Pivotal-Phase-3-Clinical-Program-with-Sozinibercept-in-Wet-AMD.html
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