Upcoming meeting will explore new technologies for glaucoma clinical drug trials

NEI/FDA CDER Glaucoma Clinical Drug Trial Design and Endpoints Symposium, March 13–14

Rockville, MD — The National Eye Institute (NEI) and the Food and Drug Administration (FDA) are sponsoring a symposium to consider new disease-relevant outcome measures appropriate for evaluating glaucoma therapies.

Currently, clinical drug trials for glaucoma therapies rely on standard perimetric criteria — i.e., a vision field test — as the primary functional outcome measure.

However, new technologies that assess abnormalities and changes in the optic nerve structure and its function offer vision researchers alternative pathways to better diagnose and treat glaucoma.

This symposium will focus on new outcome measures appropriate for evaluation of glaucoma therapies. The aim is to encourage the development of new glaucoma therapies, facilitate their evaluation and ultimately benefit patients.

Attendees will include:

• Clinical researchers/basic scientists
• Clinical trialists
• Pharmaceutical company representatives
• Legal/advocacy firms
• Associations
• Biotech companies

Registrants will be able to submit questions/comments in advance through a link on their registration confirmation notice.

Glaucoma facts

Glaucoma — a potentially blinding but treatable group of diseases — affects 2.2 million Americans age 40 and older, resulting in direct medical costs of $2.86 billion annually.

• Glaucoma robs individuals of peripheral and eventually central vision.
• Glaucoma is a complex group of neurodegenerative diseases that arises from progressive damage to the optic nerve and retinal ganglion cells and their axons.
• It is one of the four major aging eye diseases, alongside age-related macular degeneration, diabetic retinopathy and cataracts.
• About 50 percent of sufferers are unaware they have the disease.
• Glaucoma disproportionately affects minority populations: It is three times more common in African Americans than in whites and is the leading cause of irreversible vision loss in African Americans and Hispanics.
• There is a large public health burden from glaucoma due to decreased productivity, reduced independence and diminished quality of life.

Meeting management by The Association for Research in Vision and Ophthalmology (ARVO). For more information or to register, please visit www.arvo.org/endpoints or contact Lancey Cowan (Lcowan@arvo.org; +1.240.221.2944.