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NEI and FDA Hold Second Glaucoma Endpoints Meeting

Left to right: Program Co-Chairs Paul Kaufman, M.D. (University of Wisconsin-Madison) and Robert Weinreb, M.D. (University of California-San Diego)
Left to right: Program Co-Chairs Paul Kaufman, M.D. (University of Wisconsin-Madison) and Robert N. Weinreb, M.D. (University of California-San Diego)
On September 24, the NEI and FDA jointly held a Glaucoma Clinical Trial Design and Endpoints Symposium which engaged the glaucoma research community and the drug and device approval divisions within the FDA-specifically the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). Subtitled Measures of Structural Change and Visual Function, this meeting followed up on an initial March 2008 symposium by reviewing the latest research to examine whether measures of structural change can correlate to visual function and therefore serve as endpoints in clinical studies to support the approval of new drug and device diagnostics and therapies for glaucoma. Additional endpoints could potentially make glaucoma trials more logistically feasible by reducing study length, cost, and number of participants enrolled, thereby getting new therapies to patients sooner.

At the March 2008 meeting, FDA representatives stated that new clinically relevant endpoints could be considered in the regulatory review process if they are properly validated. At the follow-up meeting, noted glaucoma researchers, many funded by the NEI, reported data from studies of several imaging techniques to determine structural changes to the optic nerve head or retinal nerve fiber layer that may be correlated to visual function changes in glaucoma progression. For each imaging technique, speakers addressed the optimal criteria for measuring the rate of tissue loss and defining structural events, the statistically significant extent of structural change considering known variability of the imaging technique, and how structure predicts clinically relevant functional outcomes.

The Symposium, managed by ARVO, is the fourth in a series of collaborative meetings between the NEI and FDA, following up on the November 2006 Ophthalmic Clinical Trial Design and Endpoints Symposium, which focused on new treatments for AMD and diabetic retinopathy, and the September 2009 Patient Reported Outcomes meeting. The symposia grew out of NAEVR-initiated meetings between the NEI and FDA and exemplify NEIís leadership in facilitating the translation of its basic research, an NIH priority. At a June 2 initial Stakeholders meeting held by the newly formed NIH/FDA Joint Leadership Council, NAEVR testified that the series of NEI/FDA Endpoints Symposia respond to the Councilís mission to ensure that the latest research is being integrated into the regulatory review process.

Left to right: FDA Co-sponsors Malvina Eydelman, M.D., (Director, CDRHís Division of Ophthalmology, Neurology and Ear, Nose and Throat Devices) and Wiley Chambers, M.D. (Acting Director, CDERís Division of Anti-Infective and Ophthalmic Products)
Left to right: FDA Co-sponsors Malvina Eydelman, M.D., (Director, CDRHís Division of Ophthalmology, Neurology and Ear, Nose and Throat Devices) and Wiley Chambers, M.D. (Acting Director, CDERís Division of Anti-Infective and Ophthalmic Products)
Left to right: Dr. Eydelman with National Eye Institute Deputy Director Deborah Carper, Ph.D.
Left to right: Dr. Eydelman with National Eye Institute Deputy Director Deborah Carper, Ph.D.
Left to right:  ARVO Executive Director Joanne Angle with speaker Joel Schuman, M.D. (University of Pittsburgh)
Left to right: ARVO Executive Director Joanne Angle with speaker Joel Schuman, M.D. (University of Pittsburgh)
Left to right: Imaging panel members included Christopher Leung, M.D. (The Chinese University of Hong Kong), Gianmarco Vizzeri, M.D. (University of Texas Medical Branch), and Felipe Medieros, M.D. (University of California-San Diego)
Left to right: Imaging panel members included Christopher Leung, M.D. (The Chinese University of Hong Kong), Gianmarco Vizzeri, M.D. (University of Texas Medical Branch), and Felipe Medieros, M.D. (University of California-San Diego)
Left to right: Dr. Kaufman with Mae Gordon, Ph.D., (Washington University School of Medicine), who serves on the NEIís National Advisory Eye Council (NAEC)
Left to right: Dr. Kaufman with Mae Gordon, Ph.D., (Washington University School of Medicine), who serves on the NEIís National Advisory Eye Council (NAEC)
Left to right:  NAEVR Executive Director James Jorkasky with speaker Murray Fingeret, O.D. (Veterans Administration New York Harbor Health Care System)
Left to right: NAEVR Executive Director James Jorkasky with speaker Murray Fingeret, O.D. (Veterans Administration New York Harbor Health Care System)