Photrex undergoes confirmatory study for AMD

SANTA BARBARA, Calif. — In accordance with a Food and Drug Administration request, Miravant’s drug for the treatment of wet age-related macular degeneration, Photrex, will undergo a phase 3 confirmatory clinical study, the company announced in a press release.

The placebo-controlled trial will be conducted outside the United States, the company said. Each study patient will receive Photrex (rostaporfin, also known as SnET2) or placebo treatments over the course of 9 months. Miravant said it would conduct a primary efficacy endpoint analysis at 12 months that will be submitted for FDA review and subsequent marketing approval, pending positive results. Patients will continue to be evaluated for a second year to confirm the longer-term results established in previous phase 3 studies.

Miravant expects to begin patient enrollment in mid-2005, the release said.