by Dan Roberts
(Updated March 10, 2005)
Doctors reported successful results from analyses of Miravant Medical Technologies' Phase III clinical trials for Photrex (aka rostaporfin or SnET2) on October 25, 2004 at the American Academy of Ophthalmology (AAO) meeting in New Orleans. Photrex is a proprietary photodynamic therapy drug which has been studied in two randomized, placebo controlled two-year trials. Photrex treatment (0.5mg/kg) significantly slowed both classic and occult CNV leakage and fluid accumulation, and it improved visual acuity in cases of occult choroidal neovascularization (CNV) lesions and the treatment. Currently, no FDA-approved therapies are approved in the U.S. for occult CNV lesions.
Providing supportive evidence for the outcomes were Edgar L. Thomas, M.D., Retina-Vitreous Associates, Los Angeles, Ronald P. Danis, MD, University of Wisconsin Fundus Photograph Reading Center, Madison, and Baruch Kuppermann, MD, PhD, University of California, Irvine. Retreatment guidance was offered by Carl Regillo, MD, Wills Eye Hospital, Philadelphia.
The trials were conducted at 60 U.S. ophthalmology centers. On September 30, 2004, the Company announced that it had received an FDA Approvable Letter for Photrex, which included a request for a confirmatory clinical trial.
UPDATE: On March 10, 2005, Miravan announced that it will conduct a confirmatory Phase III clinical trial for Photrox at investigational sites in Central and Eastern Europe (CEE) and the United Kingdom. The randomized, placebo-controlled study, reviewed by the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment, will evaluate a range of patients with wet age-related macular degeneration (AMD), including both classic and occult lesions.