Macular Telangiectasia Type 2 (MacTel) progressively damages the retina, the eye’s central structure for vision. MacTel typically emerges in adulthood, gradually impairing vision as retinal cells deteriorate. The disease alters the retinal blood vessels, impairing their ability to deliver oxygen and nutrients to the retina.
The treatment system Encapsulated Cell Therapy (ECT) from Neurotech utilizes gene therapy as a method to deliver proteins for extended therapy of chronic eye diseases. The medical device includes a small capsule containing retinal pigment epithelium (RPE) cells engineered to produce therapeutic proteins. The genetic modification of these cells enables them to produce proteins that serve as treatment for diseases. The surgical implantation of the capsule inside the eye allows the outer membrane to perform both nutrient intake and protein-release functions for treating eye diseases. The membrane defends cells from immune system response, which enables them to work effectively throughout the treatment period.
Neurotech Pharmaceuticals Inc. obtained FDA approval for its ENCELTO revakinagene taroretcel-lwey product as a treatment for the rare condition Macular Telangiectasia Type 2 (MacTel). The retinal condition MacTel appears in adulthood and produces continuous irreversible visual deterioration that severely inhibits patient life quality. Cells derived from ENCELTO provide sustained delivery of ciliary neurotrophic factor (CNTF) to slow disease progression.
ENCELTO stands as the first and only FDA-approved therapy for MacTel. FDA approval of ENCELTO followed two Phase 3 clinical trials, which demonstrated a substantial delay in macular photoreceptor loss in patients with MacTel for twenty-four months after the surgical placement of the device.
ENCELTO is expected to launch in the U.S. in June 2025. Richard Small, the Chief Executive Officer, expressed his thoughts on the momentous achievement during his announcement to patients and the retina community. “I wish to express appreciation to clinical study participants, investigators, and their staff members, along with all Neurotech employees who have enabled this achievement.”
According to Dr. Charles C. Wykoff from Retinal Consultants of Texas in Houston, TX, he observes the effects that MacTel has on patients’ quality of life. “With the FDA approval of our treatment, I’m sure that ENCELTO will slow the disease for many patients and provide them with an opportunity to retain more vision in the long term.”
The physician, Dr. Thomas M. Aaberg Jr., Chief Medical Officer, declared that the day marks a pivotal milestone for MacTel patients since ENCELTO received FDA approval for treating this potentially blinding medical condition. “The start of a future unfolds today that shows promise for reducing vision deterioration from MacTel for the affected population and their supporters.”
References: Neurotech. Neurotech’s ENCELTO™ (revakinagene taroretcel-lwey) Approved by the FDA for the Treatment of Macular Telangiectasia Type 2 (MacTel). Published March 6, 2025. Accessed March 10, 2025. Neurotech_Press-Release_BLA_Approval_FINAL.pdf
