First FDA-Approved Treatment for MacTel Now Performed in the United States

Neurotech Pharmaceuticals has announced the first commercial manufacturing, shipment, and surgical procedure of ENCELTO (revakinagene taroretcel-lwey), the first and only FDA-approved treatment for adults with idiopathic Macular Telangiectasia Type 2 (MacTel).

First ENCELTO Procedure Performed for MacTel

“Performing the first ENCELTO surgery for a patient with MacTel outside of a clinical trial is an important milestone,” said Charles C. Wykoff, MD, PhD, Retinal Consultants of Texas, Houston. “For the first time, we can offer a valuable and durable treatment option that slows photoreceptor loss and preserves visual function over time. Many patients with MacTel experience gradual and progressive functional decline, and it is exciting to be able to offer an option to change the course of their disease.”

MacTel is a bilateral, neurodegenerative retinal disease in adults, characterized by gradual loss of retinal cells and secondary changes to the retinal vasculature, resulting in progressive vision loss.

How ENCELTO Works

ENCELTO is an encapsulated cell-based gene therapy designed to provide long-term, sustained delivery of therapeutic proteins for chronic eye disease treatment.

Developed on Neurotech’s ECT platform, the therapy is surgically inserted into the eye. The semi-permeable capsules contain allogeneic retinal pigment epithelium (RPE) cells that have been genetically engineered to produce disease-targeting therapeutic proteins.

“This is a huge milestone for people living with MacTel,” said Richard Small, CEO of Neurotech. “For the first time, there is an FDA-approved treatment option that could change what is possible for patients. We have been working toward this for years, and seeing it become a reality is incredibly exciting for the Neurotech team and, most importantly, for the patients who may benefit.”

Important Safety Information

Who should not receive ENCELTO?

       • Pediatric patients or pregnant individuals (ENCELTO has not been tested in these populations)

       • Patients with an active or suspected eye infection at the time of surgery

       • Patients with known hypersensitivity to Endothelial Serum Free Media (Endo-SFM)

Medical conditions to inform the eye surgeon about before treatment:

       • Pregnancy or plans to become pregnant (effects on an unborn baby have not been fully studied, though rhCNTF is not found in the bloodstream)

       • Breastfeeding or plans to breastfeed (it is not known if rhCNTF passes into breast milk)

       • Any current infections

       • Current or recent use of blood-thinning medications such as warfarin, aspirin, or NSAIDs

Post-Surgery Restrictions and Care

Immediately after surgery:

       • Avoid lifting more than 20 pounds for one week

       • Keep water out of the eye for one week

       • Wear eye protection during the day and an eye shield at night for one week

       • Do not drive or operate machinery until the eye shield is removed and the surgeon confirms adequate vision recovery

Postoperative medication regimen:

       • Use a topical antibiotic (1 drop four times daily for 7 days)     

       • Use a steroid drop taper of prednisolone acetate 1% (or equivalent):

                 • 4x/day for 7 days

                 • 3x/day for 7 days

                 • 2x/day for 7 days

                • 1x/day for 7 days

Potential Side Effects

Possible risks and complications from ENCELTO or its surgical insertion include:

       • Endophthalmitis (eye infection)

       • Retinal tear or detachment

       • Vitreous hemorrhage

       • Implant extrusion

       • Suture-related irritation or exposure

       • Temporary or permanent vision loss

       • Accelerated cataract formation

       • Delayed dark adaptation

Common postoperative symptoms:

       • Foreign body sensation in the eye

       • Redness, irritation, or dryness

       • Discharge

       • Mild to moderate pain or discomfort

       • Floaters

       • Headache