October 25, 2006
The Optobionics Pilot Clinical Study Shows Promising Vision Improvement for Retinitis Pigmentosa Patients
Optobionics Corporation, a developer of innovative medical devices for the treatment of vision loss due to degenerative retinal diseases, today provided an update on the interim results from its multi-center, pilot clinical study of the Artificial Silicon Retina (ASRÃ®) device. Results from the 20 patients treated with the ASR device show measurable vision improvement in a significant number of Retinitis Pigmentosa patients. These patients currently have no treatment options available and face deteriorating vision leading to blindness. Patients were enrolled in the study to assess safety and develop effective vision measures under an Investigational Device Exemption application approved by the U.S. Food and Drug Administration. The patients were followed for at least 12 months.
The study results were presented on September 11, 2006 at the Annual Meeting of the American Society of Retina Specialists (ASRS) in Cannes, France, by John S. Pollack, MD. Data showed that forty percent (4/10) of treated patients without postoperative cataract progression or other potential confounding factors, attained ten letter improvement compared to a loss in vision for a typical, untreated Retinitis Pigmentosa patient. In addition, subgroup analysis of the data yielded important information that will allow optimal design of a pivotal trial.
Dr. John Pollack, an Assistant Professor of Ophthalmology at the Rush University Medical Center in Chicago and a principal investigator for the ASR device study commented, "The twelve-month data from this pilot trial look quite promising. The safety profile of the ASR device implant remains very strong and I'm impressed by data that suggest that the ASR implant is producing an effect that results in maintained or improved visual acuity in a significant percentage of these Retinitis Pigmentosa patients. This patient population is desperate for treatment options, so small gains in visual acuity, or even stabilization of vision alone, would be a major step in the treatment of this progressive degenerative eye disease."
"We are very pleased with the data and analysis from our pilot clinical trial," said Mike Selzer, President and CEO of Optobionics. "These trial results continue to demonstrate an excellent safety profile for our ASR device. While this study was not powered to show statistical significance, we are highly encouraged with the trend toward positive effectiveness and with our ability to assess this improvement with appropriate test methods. To have such compelling visual acuity data at this stage and to corroborate the results from the first 10 implants we completed in 2002 brings us a step closer to having a treatment for the more than 270,000 Retinitis Pigmentosa patients in the developed world."
In August 2006, the company initiated a limited, prospective confirmatory study under a Ministry of Health approved clinical protocol at the APEC Hospital Dr. Luis Sanchez Bulnes in Mexico City with principal investigator, Hugo Quiroz-Mercado, MD.
Optobionics is a private, medical device company focused on developing and commercializing innovative neuro-stimulation therapies to restore function and quality of life for people who are vision impaired and/or deteriorating toward blindness due to retinal degeneration. Optobionics' ASR Ã® device is an investigational device that is currently in clinical trials for Retinitis Pigmentosa. For more information, visit www.optobionics.com.
This release contains information about management's view of our future expectations, plans and prospects that constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from historical results or those indicated by these forward-looking statements as a result of a variety of factors including, but not limited to, risks and uncertainties associated with, our ability to complete our ongoing or any future clinical trials, delays in conducting or completing any of our clinical trials or submitting data to the FDA within the time periods we estimate, delays in enrolling patients in our clinical trials, the results of any of our clinical trials, which may not be successful or sufficient to secure regulatory approval for our products, our ability to successfully commercialize any approved product, our ability to compete successfully with competitors, our ability to protect and enforce our intellectual property rights and our financial condition.