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AMD laser granted expedited review by FDA

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SANTA BARBARA, Calif. — A laser used to activate a drug and light treatment for patients with age-related macular degeneration has been granted expedited review status by the Food and Drug Administration, according to the developers.

The Iris Medical OcuLight 664 Ophthalmic PDT laser is used to activate SnET2, a drug and light treatment for people with wet AMD, according to codevelopers Miravant and Iridex in a press release. Earlier this month SnET2 was accepted by the FDA with a priority review status. The PDT treatment is classified by the FDA as a combination drug and device product, according to the press release.

The laser was tested with SnET2 in two independent phase 3 trials, the developers said. If approved, Iridex will be the sole provider of the laser.