SANTA BARBARA, Calif.--(BUSINESS WIRE)--Sept. 30, 2004--Miravant Medical Technologies (OTCBB:MRVT - News), a pharmaceutical development company specializing in photodynamic therapy (PDT), today announced that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for its proprietary drug SnET2. The letter outlines the conditions for final marketing approval, which includes a request for an additional confirmatory clinical trial. SnET2 PDT is a drug-and-light procedure that is being developed to slow the progression of wet age-related macular degeneration (AMD), the leading cause of blindness in older adults.
Gary S. Kledzik, Ph.D., chairman and chief executive officer, stated, "We are pleased with the approvable designation, which reflects positively on the results achieved in phase III clinical trials. The Company will work with the FDA to address the issues needed for final approval. We expect that this guidance, coupled with the knowledge we have gained about wet AMD through the phase III studies, should enable us to efficiently fulfill the requirements. We remain committed to serve the large elderly population with wet AMD, and we again thank the investigators and patients who participated in these important clinical trials."
SnET2 intended to stabilize vision loss
It is estimated that over the next five years, 1.35 million people within the U.S. will develop wet AMD, with similar numbers outside the U.S. A debilitating eye disease, wet AMD is characterized by the growth of abnormal blood vessels (choroidal neovascularization, or CNV) at the back of the eye. The lesions leak fluid and blood that can lead to severe loss of central vision. SnET2 PDT uses a light-activated drug designed to selectively destroy the leaking vessels and stabilize vision loss.
CNV lesions are made up of classic and/or occult components, and it is important that new treatments address both of these components. In the phase III clinical trials, SnET2 showed benefit in a range of CNV lesions, regardless of the percent classic component or presence of occult component.
Source: Miravant Medical Technologies