Topline results from a phase 1/2 study of DE-122 suggest bioactivity of the agent in cases of refractory wet age-related macular degeneration, according to a press release from Santen.
The data were presented at Angiogenesis, Exudation, and Degeneration 2018 hosted by Bascom Palmer Eye Institute in Miami.
The open-label, dose-escalation, sequential-cohort study assessed the safety, tolerability and bioactivity of DE-122 (carotuximab) as a single intravitreal injection at four dose levels in 12 patients, three patients per dose, with AMD refractory to treatment with anti-VEGFs.
Study subjects were followed for up to 90 days, and no serious adverse events were reported. Bioactivity was measured by mean change in central retinal subfield thickness as seen on spectral-domain OCT.
DE-122 is a novel ophthalmic formulation of carotuximab and is active in preclinical choroidal neovascularization models. It may enhance the effect of anti-VEGF agents in the treatment of wet AMD and is also under study in combination with Lucentis (ranibizumab, Genentech) compared with ranibizumab alone in a phase 2a randomized clinical trial to assess efficacy and safety in patients with wet AMD, the release said.