FEB 15, 2019
The FDA has fast-tracked Neurotech’s implant for stalling central vision loss in people with type 2 macular telangiectasia (MacTel).
The device, Renexus, is a semipermeable fiber membrane filled with human retinal pigment epithelium cells that secrete ciliary neurotrophic factor (CNTF). It is inserted through a small scleral incision and sutured in place during a 20-minute outpatient procedure. Preclinical studies hint that the implant can slow photoreceptor loss for approximately 2 years.
“Currently there are no treatment options available for MacTel patients,” said Richard Small, CEO of Neurotech. “Fast Track offers several key advantages, including the opportunity to work closely with the FDA through more frequent meetings and communications, eligibility for a rolling submission of completed sections of the Biologic License Application and potential eligibility for Accelerated Approval and Priority Review.”
In a phase 2 trial conducted at 11 sites across the United States and Australia, researchers randomized 67 participants to receive the implant or sham. According to Emily Chew, MD, who presented topline results from the trial during Retina Subspecialty Day at AAO 2017, the implant slowed photoreceptor loss with few adverse events. The treatment group showed 31% less ellipsoid zone loss along with increases in macular thickness and stable reading speeds compared with sham-treated patients.
Neurotech is currently evaluating the device in a pair of parallel phase 3 studies at sites in the United States, Australia and Europe. The trials are expected to conclude in early 2021.