Phase 2b study results of OPT-302, an anti-VEGF-C/-D ‘trap’ agent administered in combination with Lucentis (ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration (AMD), have been published online in Ophthalmology.
OPT-302 has been developed by the clinical stage biopharmaceutical company Opthea Limited.
The prospective, randomised, controlled Phase 2b trial of 366 treatment-naïve patients with wet AMD was conducted at 109 clinical sites across the United States, Europe, and Israel.
It 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 favourable safety.
The U.S. Food and Drug Administration 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.
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
