History

Dr. John Jarding

Dr. George O Clock

Dr. John Jarding and Dr. George O Clock, co-founders of Acuity Medical, Inc., demonstrated successfully treatment of MD patients using the Acuity FDA approved stimulating device in the early 2000’s. Over a ten year period the therapy continued to improve with additional research and development. It started in 1998 when they began working on research initiated by Leland Michael, O.D., in the application of restimulation of the eye and nutritional supplementation for the treatment of Macular Degeneration (MD). Early research by Dr. John B. Jarding and his knowledge of eye health and Dr. George D. O Clock demonstrated the potential positive clinical utility of using BioCurrent Ocular Therapy to treat Macular Degeneration. Previous work on cellular cancer, visual disease, wound healing and neurological disorders by O Clock further enhanced the development of the company’s understanding of safe and effective electrotherapeutic applications. Together these two forward thinking medical professionals and researchers proved the theory that restimulation of retinal tissues could reverse the effects of MD and dramatically improve vision.

How it Happened

Based on the early results of their research, the FDA was contacted in order to establish what clinical strategies would be acceptable to the agency for further patient testing under an Investigative Device Exemption (IDE).

In 1998 the company initiated an open label study following FDA guidelines, which enrolled 404 patients. These patients received a total of more than 6,500 in-office treatments with additional treatments done by the patients themselves at home. A total of 85 percent of the patients experienced an improvement of 1 or more Snellen acuity lines, 61% gained 2 or more lines, 42 % experienced an improvement of 3 or more lines, and 26% gained 4 or more lines of acuity. Only 2% experienced a loss in acuity over the period. No serious adverse effects were observed.

Following the open label study, the Company filed an IDE (#G020106) with the FDA in 2002 for a feasibility trial and completed clinical testing in 30 symptomatic patients and 10 symptomatic control patients under an approved, double-masked and randomized protocol.
The study was conducted from January 2003 to April 2004 under an approved FDA protocol. In this feasibility study after 2 weeks of therapy 59% of the treated eyes gained 5 or more acuity letters (ETDRS scale = 1 Snellen acuity line), versus 11% in the control group, and 26% of the treated eyes gained 10 or more letters (2 Snellen acuity lines), versus 11% in the control group. The results, consistent with the results of the much larger open label study were presented to the FDA in January 2005. The company has continued development of both clinical and at home therapy systems and was approved for sale in Europe in late 2008.