Phase 2b study results of OPT-302, an anti-VEGF-C/-D ‘trap’ agent administered in combination with Lucentis (ranibizumab) for the treatment of wet age-related macular degeneration (AMD), have been published online in Ophthalmology, the journal of the American Academy of Ophthalmology.
OPT-302 has been developed by Opthea Limited, a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases.
The prospective, randomised, 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 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 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 favourable safety profile.
OPT-302 combination therapy can deliver vision that is significantly superior to anti-VEGF-A monotherapy
“We are gratified that these important clinical findings from the Phase 2b trial have been published in Ophthalmology, an internationally recognised 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.”
Professor Tim Jackson, lead author and Consultant Ophthalmic Surgeon at King’s College London, commented, “Recently, a focus in wet AMD has been on emerging approaches to extend dosing intervals, which is important, but patient surveys indicate that they rank their main goal as achieving better vision over durability. The promising results of this Phase 2b trial show that OPT-302 combination therapy can deliver vision that is significantly superior to anti-VEGF-A monotherapy, and so we look forward to the results of the ongoing Phase 3 studies in wet AMD.”
The U.S. Food and Drug Administration (FDA) granted OPT-302 Fast Track Designation for the treatment of wet AMD. This designation 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 https://clinicaltrials.gov.
Reference
Jackson T, Slakter J, Buyse M, Gerometta M, Baldwin M, Price C. A randomized controlled trial of OPT-302, a VEGF-C/D inhibitor for neovascular age-related macular degeneration. Ophthalmology. doi.org/10.1016/j.ophtha.2023.02.001
