September 4, 2008
Neurotech Wins Fast Track Designations for Intraocular Drug
Neurotech Pharmaceuticals, a biotechnology company focused on the development of sight-saving therapeutics for chronic retinal diseases, has announced that the FDA has granted fast track designations for NT-501 for the treatment of visual loss in two indications - retinitis pigmentosa and the dry form of age-related macular degeneration.
Neurotech is conducting two Phase II/III trials of NT-501 for the treatment of visual loss associated with retinitis pigmentosa (RP)-one consisting of patients with earlier stage disease (60 patients) and the second consisting of patients with later stage disease (60 patients).Both trials are randomized, multi-centered, double-masked, sham-controlled dose ranging studies. Each patient receives either a high or low dose NT-501 implant in one eye and a sham treatment in the fellow eye. The primary efficacy endpoint is visual field sensitivity for the early-stage RP study and best corrected visual acuity for the late-stage RP study.
The Phase II dry age-related macular degeneration (dry AMD) study is a randomized, multi-centered, double-masked, sham-controlled study that will evaluate NT-501 in 48 subjects with an advanced stage of dry AMD called geographic atrophy. Each subject receives either a high or low dose NT-501 implant or a sham treatment in one eye only. Best corrected visual acuity is the primary efficacy endpoint of this study.
NT-501 is an intraocular, cell containing polymer implant designed to provide continuous, long-term release of the therapeutic protein ciliary neurotrophic factor directly into the back of the eye by means of the company's proprietary encapsulated cell technology.
Ted Danse, president and CEO of Neurotech, said: "We remain on track to announce top line results from our two Phase II/III studies in RP and our Phase II study in dry AMD by early 2009.
"The receipt of fast track designations for NT-501 in these indications is an important component in our ongoing product development strategy, allowing us to potentially accelerate our two clinical development programs as we seek to provide much needed treatment options for patients facing these devastating diseases."