Opthea completes enrollment in two phase 3 trials of sozinibercept in wet AMD
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Key takeaways:
- The COAST and ShORe trials have enrolled a total of 1,984 patients with wet AMD.
- The trials will examine the safety and efficacy of sozinibercept combined with anti-VEGF-A therapy vs. standard of care alone.
Opthea has completed enrollment of its phase 3 COAST and ShORe trials, which will investigate the safety and efficacy of sozinibercept in combination with anti-VEGF-A therapy for wet age-related macular degeneration.
According to a company press release, sozinibercept is a soluble form of VEGF receptor 3 that binds and neutralizes VEGF-C and VEGF-D on their endogenous receptors to prevent blood vessel growth and vascular leakage.
With a combined 1,984 treatment-naïve wet AMD patients, the two multicenter, double-masked, randomized trials comprise one the largest phase 3 programs in wet AMD, the release stated. The COAST trial, which enrolled 998 patients, will assess intravitreal 2 mg sozinibercept in combination with 2 mg aflibercept, while the ShORe trial, with 986 enrolled patients, will study sozinibercept in combination with 0.5 mg ranibizumab. Both studies compare combination therapy vs. standard of care alone.
“Based on the positive phase 2b wet AMD data demonstrating significant vision gains with the combination of sozinibercept and ranibizumab vs. ranibizumab monotherapy, the pivotal phase 3 COAST and ShORe trials were designed to demonstrate superior vision outcomes and support a potential broad label for use with any anti-VEGF-A therapy,” Arshad M. Khanani, MD, MA, FASRS, Opthea’s chief medical advisor, told Healio.
The mean change in best corrected visual acuity from baseline to week 52 serves as the primary endpoint for both trials; safety and tolerability over 2 years will also be evaluated.
“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,” Frederic Guerard, PharmD, Opthea’s CEO, said 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 [biologics license application] submission.”
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