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The FDA granted the premarket approval application (PMA) for the new Photofrin 630 PDT Laser. Photodynamic therapy (PDT) with Photofrin is a light-based cancer treatment that combines a photosensitizing drug called Photofrin (porfimer sodium) with a specific type of light administered by a laser to attack cancer cells.

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The newly approved laser, which is designed for use with Photofrin to treat esophageal cancer, Barrett's Esophagus, and non-small cell lung cancer, has been re-engineered with technological advancements in laser design. These advancements include new controls and peripheral systems while maintaining the same specifications with minimal changes to the treatment procedures.


Photofrin is also being evaluated as a rare disease product candidate through a phase III clinical trial. The ongoing trial is evaluating the product's safety and efficacy as a potential treatment for cholangiocarcinoma, or bile duct cancer, which is a rare disease affecting approximately 2,000-3,000 patients annually in the U.S.