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Photrex to enter European ‘confirmatory’ phase 3 trial

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SANTA BARBARA, Calif. — A photodynamic therapy agent for the treatment of age-related macular degeneration will begin confirmatory phase 3 trials in Central and Eastern Europe and the United Kingdom, the drug’s marketer said in a press release.

Photrex (rostaporfin for injection, Miravant Medical Technologies) will undergo a randomized, placebo-controlled study to be reviewed by the U.S. Food and Drug Administration; the trial will evaluate a range of patients with wet AMD, including both classic and occult lesions, according to Miravant.

The FDA requested the single confirmatory study as part of its approvable letter issued last September, according to a press release from Miravant. The trial will be conducted at 50 clinical sites. Miravant expects about 600 patients to be enrolled and plans to conduct a primary efficacy endpoint analysis at 12 months after initial treatment.