Neurotech granted fast track designation for intraocular implant

LINCOLN, R.I. — The U.S. Food and Drug Administration has granted fast track designation to Neurotech Pharmaceuticals for an intraocular implant being developed for treating retinitis pigmentosa and dry age-related macular degeneration, the company announced in a press release.

The company is currently conducting three randomized, multicenter, double-masked, sham-controlled trials of the NT-501, a cell-containing polymer implant designed to provide continuous, long-term release of the protein ciliary neurotrophic factor using Neurotech's proprietary encapsulated cell technology, the release said.

Specifically, Neurotech is conducting two phase 2/3 trials of NT-501 for treatment of visual loss associated with retinitis pigmentosa, one consisting of 60 patients with early-stage disease and the second consisting of 60 patients with late-stage disease. All patients are receiving a high- or low-dose NT-501 implant in one eye and a sham treatment in the fellow eye. The investigators are primarily evaluating results for the implant's ability to increase visual field sensitivity in early-stage patients and best corrected visual acuity in late-stage patients.

In a separate phase 2 trial, investigators are evaluating BCVA improvement among 48 patients with dry AMD who are being treated with high- or low-dose NT-501 implant or a sham treatment in one eye only, according to the release.

"We remain on track to announce top-line results from our two phase 2/3 studies in [retinitis pigmentosa] and our phase 2 study in dry AMD by early 2009," Ted Danse, president and chief executive officer of Neurotech, said in the release.