Concordia’s Photodynamic Therapy Laser Receives Premarket Approval

Concordia International Corp. said that the U.S. Food and Drug Administration has approved the Company's premarket approval application for its Photofrin 630 PDT (photodynamic therapy) Laser.

PDT with Photofrin is a light-based cancer treatment that combines the photosensitizing drug Photofrin (porfimer sodium) with a specific wavelength of laser light to attack cancer cells.

Concordia said the newly approved laser — designed for use with Photofrin to treat esophageal cancer, Barrett's Esophagus and non-small cell lung cancer — has been reengineered with new controls and peripheral systems, while maintaining the same specifications with minimal changes to the treatment procedures.

The company is also evaluating Photofrin as a potential treatment for cholangiocarcinoma, or bile duct cancer, which is a rare disease affecting approximately 2,000 to 3,000 patients annually in the U.S.