Medical Devices

U.S. FDA premarket approval sought for device to treat dry age-related macular degeneration

Published in Biotech Business Week, November 7th, 2005

Acuity Medical is working with the U.S. Food and Drug Administration (FDA) to design the pivotal premarket approval (PMA) clinical trial for TheraMac, 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 received CE Marking in Europe in 2002.

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Source: Biotech Business Week (2005-11-07)

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