Opthea completes enrollment in pivotal Phase 3 clinical program with sozinibercept in wet AMD


According to the company, its Phase 3 program enrolled 1,984 patients across COAST and ShORe trials. Topline data from both pivotal trials are expected in 2025.

(Image Credit: AdobeStock)

(Image Credit: AdobeStock)

Opthea Ltd announced it has now completed enrollment in both the COAST (NCT04757636) and ShORe (NCT04757610) trials constituting its pivotal Phase 3 clinical program.

According to the company, the 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.1

Arshad M. Khanani, MD, MA, FASRS, chief medical advisor of Opthea, noted in the news release the milestone brings the company “closer to our goal of improving visual outcomes for patients with wet AMD.

“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,” he said in the news release. “These data formed the basis for this large, global Phase 3 clinical program.”

The company noted in its news release its Phase 3 clinical program includes 2 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 1984 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.

Moreover, the company noted the 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.

Frederic Guerard, PharmD, CEO of Opthea, said in the news release sozinibercept is “the only late-stage asset in development in more than 15 years that is targeting better visual outcomes for wet AMD patients in combination with standard-of-care anti-VEGF-A therapies.”

“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,” he concluded in the news release.

Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralizes the activity of VEGF-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. VEGF-C and VEGF-D are known to independently stimulate retinal angiogenesis and vascular leakage and permeability, while VEGF-A inhibition can also lead to the upregulation of VEGF-C and VEGF-D.

Research shows that the targeted inhibition of VEGF-C and VEGF-D with sozinibercept can prevent blood vessel growth and vascular leakage, which both contribute to the pathophysiology of retinal diseases, including wet AMD.

In Opthea’s prospective, randomly assigned 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.

According to the news release, the 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.1

  1. Limited O. Opthea Completes Enrollment in Pivotal Phase 3 Clinical Program with Sozinibercept in Wet AMD. GlobeNewswire News Room. Published May 28, 2024. Accessed May 29, 2024. https://url.us.m.mimecastprotect.com/s/ox-ICZ6RoRix9AwLHzGcYZ?domain=globenewswire.com
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