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Wet AMD drug receives ‘approvable’ letter from FDA

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SANTA BARBARA, Calif. — A photodynamic therapy drug for the treatment of wet age-related macular degeneration is one step closer to receiving U.S. regulatory approval, according to Miravant, the product’s manufacturer.

Miravant announced that the Food and Drug Administration has issued an “approvable” letter for SnET2 PDT, a light-activated drug designed to selectively destroy abnormal blood vessels and stabilize vision loss in patients with wet AMD. The letter outlines conditions for final approval, including a request for an additional confirmatory clinical trial, according to a Miravant press release.

In phase 3 clinical trials, SnET2 “showed benefit in a range of choroidal neovascularization lesions, regardless of the percent classic component or presence of occult component,” according to the company.

Miravant’s initial submission was 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.

The FDA has agreed to fast-track the drug, Miravant has stated.