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FDA accepts investigational new drug application for phase 2 trial of NT-503 encapsulated cell therapy
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The FDA has accepted an investigational new drug application for a phase 2 clinical study of NT-503 encapsulated cell therapy for the treatment of recurrent subfoveal choroidal neovascularization secondary to age-related macular degeneration, Neurotech Pharmaceuticals announced in a press release.
NT-503 is a VEGF receptor protein continuously produced by the encapsulated cell therapy platform, an intravitreal implant that houses a proprietary retinal pigment epithelial cell line genetically engineered to produce therapeutically active biologics for at least 2 years, the release said.
The phase 2, randomized, active-controlled masked study will include 150 patients who have been treated with at least three anti-VEGF injections and diagnosed with recurrent subfoveal choroidal neovascularization secondary to AMD. The study will compare the safety and efficacy of one NT-503 implant with Eylea (aflibercept, Regeneron) intravitreal injections every 8 weeks with a 2-year follow-up and a 12-month interim assessment, the release said.