SnET2-PDTTreatment for Macular Degeneration
Miravant's SnET2 New Drug Application Accepted for Filing by FDA with Priority Review Designation
SANTA BARBARA, Calif., Jun 1, 2004 - Miravant Medical Technologies (OTCBB: MRVT), a pharmaceutical development company specializing in PhotoPoint photodynamic therapy (PDT), announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for SnET2 and has also granted a Priority Review designation. Acceptance of the filing means that the FDA has made a determination that the NDA meets the standard for substantive review, and the Priority Review designation expedites the review period. Miravant is seeking approval from the FDA for its proprietary new drug SnET2 as a treatment for patients with wet age-related macular degeneration (AMD), a leading cause of blindness in older adults.
Wet AMD is a major health problem with an estimated 500,000 new cases each year worldwide. The disease is characterized by abnormal blood vessels at the back of the eye that leak fluid and blood and can lead to severe loss of central vision. The SnET2 treatment uses a light-activated drug intended to selectively destroy these abnormal blood vessels and stabilize vision loss.
Miravant Medical Technologies specializes in pharmaceuticals and devices for photoselective medicine, developing its proprietary PhotoPoint photodynamic therapy (PDT) for large potential markets in ophthalmology, dermatology, cardiovascular disease and oncology. PhotoPoint PDT uses photoreactive (light-activated) drugs to selectively target diseased cells and blood vessels. The Company has submitted a New Drug Application (NDA) for the drug SnET2 for the treatment of patients with wet age-related macular degeneration. Miravant's cardiovascular program focuses on life-threatening diseases, with PhotoPoint MV0633 in advanced preclinical testing for atherosclerosis, atherosclerotic vulnerable plaque and restenosis.
Posted: June 2004