Opthea Phase 2b Trial Results of OPT-302 in Combination with Lucentis for Wet AMD Meets Primary Endpoint

Opthea announced that the phase 2b study results of OPT-302, the company’s anti-VEGF-C/-D “trap” agent administered in combination with Lucentis (ranibizumab) for the treatment of wet age-related macular degeneration (AMD), met the prespecified primary efficacy endpoint.

The prospective, randomized, controlled phase 2b trial of 366 treatment-naïve patients with wet AMD, conducted at 109 clinical sites across the United States, Europe and Israel, demonstrated that monthly intravitreal administration of 2.0 mg OPT-302 with ranibizumab standard of care, met the prespecified primary efficacy endpoint of a statistically superior gain in visual acuity at 24 weeks, compared to ranibizumab alone. In addition, secondary outcomes were positive for the OPT-302 combination therapy including more participants with gains in vision of 10 or more letters, improved anatomy of reduction in swelling and vascular leakage, with a favorable safety profile.

The study results were published online in Ophthalmology.

"We are gratified that these important clinical findings from the phase 2b trial have been published in Ophthalmology, an internationally recognized peer-reviewed journal and we also wish to thank the patients, investigators and their staff for participating and their efforts in ensuring the success of this study," said Dr. Megan Baldwin, CEO and Managing Director of Opthea. "The robust results of this large phase 2b trial have informed and provided the foundation for our ongoing phase 3 registrational program of OPT-302 in combination with anti-VEGF-A therapy for the treatment of wet AMD."

The FDA granted OPT-302 Fast Track Designation for the treatment of wet AMD, which facilitates the development and expedites the review of investigational therapies to treat serious conditions and fill an unmet medical need.

Opthea is currently conducting two global confirmatory phase 3 studies—ShORe (2 mg OPT-302 + 0.5 mg ranibizumab), and COAST (2 mg OPT-302 + 2 mg aflibercept). The primary endpoint for both studies is superiority in visual acuity gains at 12 months for the combination therapy compared with standard-of-care monotherapy. More information regarding ShORe (NCT04757610) and COAST (NCT04757636) can be found at clinicaltrials.gov.