National Institutes of Health
The National Eye Institute (NEI) and the Food and Drug Administration (FDA) invite you to help develop definitions and standards to describe structural changes in the glaucomatous optic nerve and functional changes in vision that could constitute “approvable” endpoints for new glaucoma therapeutics.
What’s on the Agenda?
- A summary of the 2007 NEI/FDA glaucoma endpoints meeting and follow-up
- Approvable endpoints: Past and present use of structural and functional endpoints in glaucoma drug and device trials
- Ophthalmic devices for assessment of structural endpoints
- Regulation of ophthalmic devices used to asses structural endpoints
- Reconciling and pooling data from different studies
- Role of patient-reported outcomes in glaucoma assessment
- Can ex-US data be used for FDA approval?
- Interactive/open discussion: toward unified structure-function outcome measure
The meeting is being managed by the Association for Research in Vision and Ophthalmology.