|FOR IMMEDIATE RELEASE
May 2, 2007
|CONTACT: James F. Jorkasky
NAEVR ACKNOWLEDGES FDA COMMISSIONER DR. ANDREW von ESCHENBACH’s COMMENTS ON AMD, NEED FOR REGULATORY MECHANISMS TO ADAPT TO SCIENTIFIC RESEARCH
(Washington, D.C.) Today, in a letter to Dr. Andrew von Eschenbach, Commissioner of the Food and Drug Administration (FDA), NAEVR Board President Dr. Stephen Ryan (Doheny Eye Institute/University of Southern California) acknowledged comments made on April 30 by Dr. von Eschenbach at a National Health Council briefing. NAEVR specifically noted Dr. von Eschenbach’s mention of the collaborative research between the National Cancer Institute and the National Eye Institute (NEI) that has resulted in the first generation of FDA-approved ophthalmic drugs to stabilize and restore vision in patients with age-related macular degeneration (AMD), the leading cause of blindness.
"This research, coupled with the discovery of gene variants in AMD associated with the body’s inflammatory response, are exemplary of the new paradigm for research as cited by both National Institutes of Health (NIH) Director Dr. Zerhouni and you—that which is preemptive, predictive, preventive, and personalized," wrote Ryan.
The letter also acknowledged Dr.von Eschenbach’s statement that FDA must adapt its regulatory process to new scientific research. In that regard, Ryan cited a November 2006 NEI-FDA collaborative meeting on Ophthalmic Clinical Trial Design and Endpoints, which focused on potential alternative endpoints in AMD and diabetic retinopathy (DR) research. Ryan also cited an April 17, 2007, Congressional Briefing he provided on Visual Imaging, in which he described the importance of quantitative measurements derived from the use of Optical Coherence Tomography (OCT) in diagnosis and treatment of eye disease. Ryan related the context of these two events to the goals of the FDA Critical Pathways Initiative by stating that, "Quantitative measurements of changes in the eye’s physiology, when coupled with a functional measurement of vision, can maximize the use of evidence-based medicine in eye care, as well as increase efficiency and reduce costs in clinical trials—a goal of both the FDA and NIH."
Ryan concluded by stating that, "The vision research community looks forward to further collaborations between the NEI and FDA to consider how the latest research can be applied to ophthalmic product approvals, not only for retinal diseases such as AMD and DR, but also complex neurodegenerative diseases such as glaucoma."
The National Alliance for Eye and Vision Research (NAEVR) is a non-profit advocacy coalition comprised of 55 professional, consumer, and industry organizations involved in eye and vision research. NAEVR’s goal is to achieve the best vision for all Americans through advocacy and public education for eye and vision research sponsored by the National Institutes of Health (NIH), the National Eye Institute (NEI) and other federal research entities. Visit NAEVR’s Web site at www.eyeresearch.org.