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Photrex phase 3 trial under way
SANTA BARBARA, Calif. — A photodynamic therapy agent has begun phase 3 trials for treatment of wet age-related macular degeneration, according to the drug’s developer.
Photrex (rostaporfin or SnET2, Miravant) has begun a multicenter, placebo controlled study designed to fulfill the requirements for additional clinical data outlined in an “approvable” letter that Miravant received from the Food and Drug Administration in 2004, the company said in a press release.
The phase 3 trial will involve approximately 50 clinical sites in Central and Eastern Europe and the United Kingdom, Miravant said. Patients with both classic and occult forms of wet AMD will be included in the study. A primary efficacy endpoint analysis is expected at 12 months after initial treatment, and about 650 patients are expected to be analyzed. Miravant said it plans to follow patients for an additional 12 months while seeking marketing approval for Photrex.