BRIGHTON, Mich., Oct. 17 /PRNewswire/ -- Acuity Medical is working with the FDA to design the pivotal pre-market approval (PMA) clinical trial for TheraMac(TM), a medical device for the treatment of dry age-related macular degeneration (AMD). Currently there is no approved treatment for dry AMD. The proposed trial will have a 3-month efficacy endpoint and a 6-month safety endpoint and will include approximately 300 patients.
The PMA trial will assure TheraMac's safety and effectiveness for its intended use and that it will be manufactured in accordance with current good manufacturing practices. TheraMac(TM) received CE Marking in Europe in 2002.
Acuity Medical has already successfully completed a proof of concept FDA trial of TheraMac(TM) 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. There were zero serious adverse events. Acuity Medical has also completed an open label study on 404 patients.
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.
AMD is the leading cause of legal blindness effecting more than 50 million people worldwide. 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.
"The initial results were extremely encouraging," according to Robert Gale Martin, M.D., Principal Investigator for Acuity Medical's TheraMac(TM). "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 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.