SnET2-PDTTreatment for Macular Degeneration
Miravant Submits New Drug Application For SnET2-PDT to Treat Macular Degeneration
SANTA BARBARA, Calif., March 31, 2004 -- Miravant Medical Technologies (OTCBB:MRVT), a pharmaceutical development company specializing in PhotoPoint(R) photodynamic therapy (PDT), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval of SnET2-PDT as a new treatment for patients with wet age-related macular degeneration (AMD). Wet AMD, a vision-threatening disorder, is characterized by the growth of abnormal blood vessels (subfoveal choroidal neovascularization, or CNV) at the back of the eye. The CNV 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 abnormal blood vessels and stabilize vision loss.
Miravant's NDA submission is based on clinical data from two randomized, placebo-controlled, parallel group Phase III studies conducted at 60 U.S. ophthalmology centers. The study population included patients with CNV associated with AMD who were followed for two years and evaluated for re-treatment every 13 weeks.
SnET2-PDT has been designated a Fast Track product by the FDA, and Miravant is requesting priority review status for the drug. Within 60 days of NDA submission, the FDA will make a determination to accept or refuse to file the NDA and, if accepted, will designate its review status.
As a part of the NDA submission, a Premarket Approval Application (PMA) was submitted for the light device used to activate SnET2 during the ocular PDT procedure. This device, the IRIS Medical OcuLight 664 Ophthalmic PDT Laser, was co-developed by Miravant and Iridex Corporation (Nasdaq:IRIX), a leading manufacturer of semi-conductor based diode lasers. SnET2-PDT is classified as a combination drug and device product, and thus the NDA and PMA are reviewed by the respective FDA drug and device divisions.
Gary S. Kledzik, Ph.D., chairman and chief executive officer, stated, "I would like to recognize the very distinguished group of retinal specialists who administered the SnET2 therapy in clinical research studies and the many patients who volunteered to participate over the course of two years. We thank them for their dedicated efforts in support of finding new treatments for this serious eye disease.
"I am extremely proud of the quality and scope of Miravant's first NDA submission, a milestone achievement after years of rigorous drug development," Dr. Kledzik added. "We are optimistic that, if approved by the FDA, SnET2-PDT may allow physicians in the future to treat a broader range of patients, with a shorter and more well defined treatment regimen than currently available."
Profound Need for AMD Treatments
Choroidal neovascularization associated with age-related macular degeneration is a major health problem in the United States and other parts of the world. At the present time, an estimated eight million persons at least 55 years old in the U.S. are considered to have AMD at high risk for progression to advanced neovascular ("wet") AMD, characterized by subfoveal CNV. Of these at-risk individuals, it is estimated that over the next five years, 1.35 million within the U.S. will develop wet AMD, with similar numbers in Europe and the rest of the world. Other estimates of the prevalence suggest that there may be as many as 12 million individuals within the U.S. with early and late stage AMD. The aging of the population suggests that this disease will become an ever-increasing medical, social and economic problem over the coming years.
Persons with wet AMD can experience significant reductions in vision and need assistance with daily activities. These individuals can be profoundly distressed and are often characterized as disabled, with severe reduction in their quality of life. In spite of the prevalence and severity of this disease, there are limited treatment options, and for most patients there is an unmet need for therapy.
Miravant Medical Technologies specializes in the development of 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.
Source: Miravant Medical Technologies
Posted: March 2004
- Miravant's SnET2 New Drug Application Accepted for Filing by FDA with Priority Review Designation - June 1, 2004