BRIGHTON, Mich., Oct. 24 /PRNewswire/ -- Acuity Medical is planning for the recruitment of clinical sites in the United States for their pivotal pre- market clinical (PMA) trial for TheraMac(TM), a medical device for the treatment of dry age-related macular degeneration (AMD). AMD is the leading cause of legal blindness effecting more than 50 million people worldwide. Currently there is no effective treatment for dry AMD.
TheraMac(TM) has already successfully completed a proof of concept FDA trial which showed that in two weeks 26% of the eyes treated had improved vision by 10 letters or more, the equivalent of two lines on the eye chart. TheraMac(TM) has also been the subject of an open label study on 404 patients and it received CE Marking in Europe in 2002.
"Our history with the FDA has been very positive," says Tom McColley, President of Acuity Medical. "This important stage of our development will allow our treatment guidelines and protocols to be further defined and hopefully bring a safe, effective treatment to an increasing population that suffers from the devastating effects of AMD."
TheraMac(TM) produces minute amounts of electrical biocurrent that is delivered to the retina through a probe that touches the skin around the eye. The biocurrent facilitates increases in membrane permeability, improves cellular functionality and stimulates cellular repair. The total time for treating one eye is approximately 15 minutes.
Macular degeneration, which is caused by the deterioration of the central portion of the retina, is diagnosed as either dry or wet. TheraMac(TM) is for use with the dry, non-bleeding form, which makes up 90% of the cases.
According to Robert Gale Martin, M.D., Principal Investigator for Acuity Medical's TheraMac(TM), "The initial results were extremely encouraging. The clinical impression was that TheraMac(TM) dramatically improved patients who had eyes with dry age-related macular degeneration. I feel that it's imperative that double blind cross-over scientific studies be carried out to confirm these initial clinical impressions."
Acuity is in discussion with several groups regarding next stage funding for the PMA clinical trial through to commercialization.
Acuity Medical, located in Brighton, Michigan, is a therapeutic technology company that is developing treatments for all aspects of macular disease. For more information, contact Tom McColley at (810) 229-5828 or at email@example.com.