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Miravant submits wet AMD drug for marketing approval
SANTA BARBARA, Calif. — A treatment for patients with wet age-related macular degeneration was submitted to U.S. regulators for approval by the drug’s maker, Miravant Medical Technologies.
Miravant announced in a news release that it submitted SnET2-PDT, a light-activated drug designed to selectively destroy abnormal blood vessels and stabilize vision loss in patients with wet AMD, to the Food and Drug Administration yesterday.
The New Drug Application submission is based on clinical data from two randomized, placebo-controlled, parallel group, phase 3 studies conducted at 60 ophthalmic centers nationwide. Patients with choroidal neovascularization were followed for 2 years and evaluated for re-treatment every 13 weeks.
SnET2-PDT has been granted fast track status by the FDA. As part of the submission, a premarket approval application for the light device used to activate SnET2 during the ocular photodynamic therapy procedure was also included, according to Miravant. The Iris Medical OcuLight 664 Ophthalmic PDT laser was codeveloped by Miravant and Iridex, according to the release. SnET2-PDT is classified as a combination drug and device product, according to Miravant, and therefore the applications will be reviewed by the respective FDA drug and device divisions.