From rxpgnews.com
Rostaporfin Photodynamic Therapy for Better Vision in wet AMD,in Phase III
By Akanksha, Pharmacology Correspondent
Feb 3, 2005, 12:23
Miravant Medical Technologies,announced today that it will conduct a phase III confirmatory clinical trial of PHOTREX(TM) (rostaporfin, formerly known as SnET2) for wet age-related macular degeneration (AMD), based on a Special Protocol Assessment by the U.S. Food and Drug Administration (FDA).
The FDA requested this single confirmatory study in its Approvable Letter issued September 2004, after reviewing the Company's New Drug Application (NDA).
The placebo-controlled trial, to be conducted outside of the United States, is designed to enroll a broad range of wet AMD patients, including patients with predominantly classic, minimally classic and occult lesions.
According to the protocol, each study patient will receive rostaporfin (or placebo) treatments over the course of nine months. The Company currently plans to conduct a primary efficacy endpoint analysis at 12 months (one year after initial treatment) which, pending positive results, will be submitted for FDA review and subsequent marketing approval. Patients will continue to be evaluated for a second year to confirm the longer-term results established in previous rostaporfin phase III studies. Miravant expects to commence patient enrollment in mid-2005.
"I am pleased to update the market on our plans to move forward with the rostaporfin clinical trial after our discussions with the FDA," said Gary S. Kledzik, Ph.D., chairman and chief executive officer. "The trial will be used to confirm the results of two pivotal studies that suggested rostaporfin could stabilize vision in a range of patients with this debilitating eye disease."
Dr. Kledzik added, "We are also planning to initiate additional studies of rostaporfin PDT in combination with other therapeutic agents for wet AMD, reflecting current trends in clinical practice where we expect photodynamic therapy to be a mainstay procedure."
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 retinal scarring and severe loss of central vision.
Rostaporfin PDT uses a light-activated drug intended to selectively destroy these abnormal blood vessels and stabilize vision loss.
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