ENCELTO™ for Macular Telangiectasia Type 2 (MacTel)

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The U.S. Food and Drug Administration (FDA) has approved ENCELTO™ (revakinagene taroretcel-lwey), the first and only treatment for Macular Telangiectasia Type 2 (MacTel). 

Understanding MacTel:

MacTel is a rare, progressive neurodegenerative disease affecting the central retina, leading to gradual and irreversible vision loss. Typically diagnosed in middle-aged adults, it is characterized by the degeneration of photoreceptors—the specialized cells responsible for capturing light and enabling vision. 

 

MacTel Type 2 with crystalline deposits and altered foveal reflex.

Introducing ENCELTO:

ENCELTO represents a pioneering approach in the treatment of MacTel. This allogeneic encapsulated cell-based gene therapy utilizes Neurotech’s Encapsulated Cell Technology (ECT) platform to deliver continuous therapeutic doses of ciliary neurotrophic factor (CNTF) directly to the retina. CNTF is a protein known to support the survival and maintenance of photoreceptors, thereby slowing disease progression. 

Clinical Efficacy:

The FDA’s approval of ENCELTO is grounded in robust clinical evidence from two Phase 3 trials. Over a 24-month period, patients receiving ENCELTO experienced a significant reduction in the loss of macular photoreceptors compared to those who did not receive the treatment. This outcome underscores the therapy’s potential to preserve vision and enhance the quality of life for individuals affected by MacTel. 

Availability:

ENCELTO is expected to be available to patients in the United States starting in June 2025, offering new hope to those impacted by this challenging condition. Worldwide availability is likely in the late 2026.

This approval marks a significant milestone in retinal disease treatment, providing a much-needed therapeutic option for patients with MacTel. For more detailed information, please refer to the official FDA announcement. 

Stay informed and consult with your ophthalmologist to determine if ENCELTO is a suitable treatment option for you.