MacTel treatment receives permanent J-code to improve access for patients

The Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-Code to revakinagene taroretcel-lwey (ENCELTO). As the award of this J-code (J3430) on October 1, 2025, this medication is the only approved treatment for Macular Telangiectasia Type 2 (MacTel), which causes progressive vision loss in those patients diagnosed with the condition. ¹

What is a J-code?

According to the press release¹ from Neurotech Pharmaceuticals, the biotech company behind revakinagene taroretcel-lwey, “J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing for treatments that must be administered by a healthcare professional. These standardized codes streamline the billing and reimbursement process, enabling efficient claims processing and supporting broader patient access.”¹

When was revakinagene taroretcel-lwey approved by the FDA?

The US Food and Drug Administration (FDA) approved the use of revakinagene taroretcel-lwey for the treatment of patients with Macular Telangiectasia type 2 (MacTel) on March 6, 2025. This approval was issued based on the results from 2 phase 3 trials. In those trials, the results showed that, after the placement of the implant, the loss of macular photoreceptors was significantly slowed over 24 months.²

Following this approval, Ophthalmology Times and Modern Retina spoke with several ophthalmologists to understand how this approval would impact the approach to this disease.

“By delivering continuous neurotrophic support to the retina, this device offers a novel approach that could slow disease progression and help preserve vision in affected individuals. This shift from passive monitoring to an active treatment strategy is a game-changer for both patients and clinicians,”³ said Rishi P. Singh, MD, FASRS, who is vice president/chief medical officer of Martin North and South Hospitals; professor of ophthalmology, Cleveland Clinic Lerner College of Medicine; Cleveland Clinic Martin Health in Stuart, Florida. He is also a member of the editorial advisory board for Modern Retina.

“It's a 100% game changer that we can delay [progression],”³ agreed Martin Friedlander, MD, PhD, who is professor, Department of Molecular Medicine, Scripps Research Institute; chief, Retina Services, Division of Ophthalmology, Scripps Clinic; and president, Lowy Medical Research Institute (LMRI), La Jolla, CA. “In many of the patients we see an absolute halting of progression of disease, which is very exciting. And so if you can preserve useful normal vision for a decade or two, that's very meaningful for these patients.”³

What is revakinagene taroretcel-lwey?

Revakinagene taroretcel-lwey is an encapsulated cell-based gene therapy that uses Neurotech’s ECT platform, which is surgically inserted. The ECT platform is made of small, semi-permeable capsules containing the proprietary allogeneic retinal pigment epithelium (RPE) cells, which are genetically engineered to produce specific therapeutic proteins for targeted disease treatment.⁴

References

1. Neurotech Granted Permanent J-Code (J3403) for ENCELTO™ (revakinagene taroretcel-lwey), Effective October 1, 2025. Press release. Neurotech Pharmaceuticals, Inc. October 1, 2025. Accessed October 2, 2025.

2. Harp, MD. Hayes, H. FDA approves revakinagene taroretcel-lwey (ENCELTO) for macular telangiectasia type 2. Ophthalmology Times. March 6, 2025. Accessed October 2, 2025. https://www.ophthalmologytimes.com/view/fda-approves-revakinagene-taroretcel-lwey-encelto-for-macular-telangiectasia-type-2

3. Friedlander, M. Loewenstein A. Rafieetary, M. Singh, R. Stevenson, S. A new era for MacTel: Clinicians react to FDA approval of revakinagene taroretcel-lwey. Ophthalmology Times. March 10, 2025. Accessed October 2, 2025. https://www.ophthalmologytimes.com/view/a-new-era-for-mactel-clinicians-react-to-fda-approval-of-revakinagene-taroretcel-lwey

4. First FDA-Approved Treatment for MacTel Performed. August 11, 2025. https://www.businesswire.com/news/home/20250811189087/en/First-FDA-Approved-Treatment-for-MacTel-Performed. Accessed August 12, 2025.