Retina drug on FDA fast track

NT-501, a Ciliary Neurotrophic Factor (CNTF)-releasing polymer indicated for the treatment of visual loss in retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), has been granted a Fast Track designation by the FDA, Neurotech Pharmaceuticals Inc, the compound's manufacturer, has announced.

Neurotech is conducting three studies on NT-501: two Phase II/III trials in RP, for early (n=60) and late (n=60) stage disease; one Phase II trial in advanced dry AMD (n=48). All trials are randomized, multi-centre, double-masked and sham-controlled.

The RP trials are dose-ranging studies, in which subjects receive a dose of NT-501 in one eye and a sham treatment in the other. The primary end-point of the early-stage study is visual field sensitivity; for the late-stage study, best corrected visual acuity. Subjects in the dry AMD trial also receive a dose of NT-501 in one eye and a sham treatment in the other: the primary efficacy endpoint is best corrected visual acuity.

Neurotech plans to announce top-line results of these three studies early next year, as was originally planned; the Fast Track designation, however, will allow the company to accelerate its clinical development programmes.