Encelto FDA Approval History
Last updated by Judith Stewart, BPharm on March 6, 2025.
FDA Approved: Yes (First approved March 5, 2025)
Brand name: Encelto
Generic name: revakinagene taroretcel-lwey
Dosage form: Intravitreal Implant
Previous Name: NT-501
Company: Neurotech Pharmaceuticals, Inc.
Treatment for: Macular Telangiectasia Type 2
Encelto (revakinagene taroretcel-lwey) is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2.
- Macular telangiectasia type 2 (MacTel) is a rare, neurodegenerative disease that affects the macula, causing in a gradual deterioration in central vision. It is characterized by changes in the macular capillary network and atrophy of the neurosensory retina.
- Encelto utilizes Neurotech's Encapsulated Cell Therapy (ECT) platform to provide sustained delivery of recombinant ciliary neurotrophic factor (rhCNTF), a potent neuroprotective protein that promotes the survival and maintenance of photoreceptors. It works to slow retinal degeneration and potentially improve long-term visual outcomes.
- FDA approval was based on the results of two phase 3 trials which demonstrated that Encelto significantly slowed the loss of macular photoreceptors in MacTel patients over 24 months.
- Encelto implants are administered by surgical intravitreal implantation under aseptic conditions by a qualified ophthalmologist.
- Warnings and precautions associated with Encelto include severe vision loss, infectious endophthalmitis, retinal tears and/or detachment, vitreous hemorrhage, implant extrusion, cataract formation, suture related complications, delayed dark adaptation, and vitreous hemorrhage.
- Common adverse reactions (incidence ≥2%) include conjunctival hemorrhage, delayed dark adaptation, foreign body sensation, eye pain, suture related complications, miosis, conjunctival hyperemia, eye pruritus, ocular discomfort, vitreous hemorrhage, blurred vision, headache, dry eye, eye irritation, cataract progression or formation, vitreous floaters, severe vision loss, eye discharge, anterior chamber cell, iridocyclitis.
Development timeline for Encelto
Further information
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