NEI/FDA To Hold One-Day Glaucoma Endpoints Meeting

Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals;  Conferences
Article Date: 28 Jul 2010 - 2:00 PDT

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The National Eye Institute (NEI) and the Food and Drug Administration (FDA) are sponsoring a Glaucoma Endpoints conference on September 24, 2010, to develop definitions and standards for describing structural changes in the glaucomatous optic nerve and functional changes in vision, as criteria for approval of new glaucoma therapeutics in clinical trials. The one-day meeting will take place at the Natcher Center, National Institutes of Health in Bethesda, Md.

While functional measures of the presence and progression of glaucomatous optic neuropathy have been developed and are currently in use, they are imprecise and poorly resolved. Likewise, the precision, resolution and rate of change for structural parameters of the optic nerve head and retinal nerve fiber layer are also not yet well-articulated.

This meeting, part of an NEI/FDA series of Endpoints Symposia, will examine such non-IOP glaucoma endpoints. Participants will explore how to increase the precision of functional measures as well as better articulate the precision, resolution and rate of change for structural parameters of the optic nerve head and retinal nerve fiber layer. In addition, they will examine how best to compare and contrast such structural measures with functional outcomes in patients' vision.

Participants will also look at whether such functional and structural measures can be combined into new endpoints for glaucoma clinical trials to shorten the timeline for clinical trials/development of potential new therapies.

Faculty will include authorities in glaucoma and glaucoma diagnosis, including the newest structural and functional testing instruments and algorithms. FDA representatives will review current optic nerve endpoints used in glaucoma drug and device trials, while researchers will discuss in detail specific techniques and criteria as well as the relationships between structural events and functional outcomes.

Who should attend?

-- clinical researchers/basic scientists

-- glaucoma specialists

-- clinical trialists

-- pharmaceutical company representatives

-- glaucoma-related associations

-- biotech companies

Source: Association for Research in Vision and Ophthalmology (ARVO)

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