FFB Written Articles » Macular Degeneration

Neurotech Capsule Receives Fast Track Status from FDA

Neurotech’s innovative encapsulated cell technology (ECT), which shows promise for treating a wide range of retinal diseases, has received Fast Track status from the FDA. Fast Track status is given to therapies that address an unmet medical need. Also, the FDA will review an application for marketing approval of a Fast Track treatment within six months. Neurotech plans to release results from their three Phase II/III clinical trials in spring 2009. At that point the company may seek FDA marketing approval for the treatment to make it generally available and/or conduct additional clinical studies.

Approximately 150 people are participating in three Phase II/III studies of the ECT. The Foundation Fighting Blindness is funding the two studies investigating the effectiveness of the device in participants who are affected by retinitis pigmentosa, certain forms of Usher syndrome, and choroideremia. The third study is evaluating the treatment in people with dry age-related macular degeneration.

Neurotech’s ECT is a tiny device — six millimeters in length — that is implanted into the eye through an outpatient procedure and can remain in the eye for a long period of time, a year or perhaps longer. The ECT provides sustained release of a vision-preserving protein known as ciliary neurotrophic factor or CNTF. The Foundation Fighting Blindness also continues to fund pre-clinical studies of other potentially protective substances that could be delivered using the device.

In the Phase I clinical trial for safety, the device appeared to slow the progress of retinal degeneration and even restored some vision in some trial participants.