Opthea Completes Enrollment in Pivotal Phase 3 Clinical Program with Sozinibercept in Wet AMD

Opthea announced that it has completed enrollment in both the COAST and ShORe trials constituting its pivotal phase 3 clinical program. This program is designed to assess the safety and superior efficacy of sozinibercept in combination with standard-of-care anti-VEGF-A therapies compared to standard of care alone for the treatment of patients with wet AMD.

“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,” Arshad M. Khanani, MD, MA, FASRS, Chief Medical Advisor of Opthea, said in a company 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.”

Opthea’s phase 3 clinical program consists of two multicenter, double-masked, randomized, sham-controlled trials COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with Ranibizumab), which enrolled 1,984 treatment-naïve wet AMD patients in total (998 patients in COAST; 986 patients in ShORe), making it one of the largest phase 3 programs in wet AMD. Both phase 3 trials combine sozinibercept with standard-of-care anti-VEGF-A therapy to assess the efficacy and safety of intravitreal 2.0 mg sozinibercept in combination with 2.0 mg aflibercept (COAST), or 0.5 mg ranibizumab (ShORe), compared to standard of care alone. The primary endpoint for both trials is the mean change in Best Corrected Visual Acuity (BCVA) from baseline to week 52. Both trials are also evaluating the safety and tolerability 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,” Frederic Guerard, PharmD, Chief Executive Officer of Opthea, said in a company news 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.”

In Opthea’s prospective, randomized and controlled phase 2b trial including 366 treatment-naïve wet AMD patients, sozinibercept was administered in combination with standard-of-care ranibizumab for the treatment of wet AMD. Sozinibercept combination therapy met the pre-specified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive with the combination therapy, including more patients gaining vision of 10 or more letters, improved anatomy, with a reduction in swelling and vascular leakage, and a favorable safety profile. These statistically significant results were published in Ophthalmology in February 2023.