Revakinagene taroretcel, sold under the brand name Encelto, is an allogeneic encapsulated cell-based gene therapy used to treat macular telangiectasia type 2. It is administered into the recipient's eye during a single surgical procedure. It works by expressing recombinant human ciliary neurotrophic factor, a factor that may promote the survival and maintenance of the macular photoreceptors. It was approved for medical use in the United States in March 2025.
Facts
Mechanism of ActionEncapsulated cell therapy technology designed to continually deliver therapeutic doses 2 Approved UseTreatment of macular telangiectasia type 2 (MacTel) 2 First Approved / Isolated Year Significant RiskImplantation has been associated with severe vision loss, infectious endophthalmitis and retinal tears 2 Prescription Status Classification
Approval Status Connections
Sources
1. Revakinagene taroretcel (Wikipedia)
Lead sectionQuote, Lead section
Revakinagene taroretcel was approved for medical use in the United States in March 2025.
2. Neurotech ENCELTO approved by the FDA for MacTel (press release)
Paragraph 1, dateline paragraph
has approved ENCELTO™ (revakinagene taroretcel-lwey) for the treatment of Macular Telangiectasia type 2 (MacTel).
Paragraph 2
ENCELTO utilizes an encapsulated cell therapy technology designed to continually deliver therapeutic doses
Highlights, Warnings and Precautions, first bullet
ENCELTO implantation has been associated with severe vision loss, infectious endophthalmitis, retinal tears
View the Source3. ChEMBL: ChEMBL molecule record for Revakinagene taroretcel (CHEMBL5314636)
ChEMBLmolecule_typeQuote, molecule_type
"molecule_type": "Gene"
4. U.S. Food and Drug Administration (openFDA): openFDA drug labels naming Revakinagene taroretcel by product type
U.S. Food and Drug Administration (openFDA)count by product typeQuote, count by product type
"term": "HUMAN PRESCRIPTION DRUG", "count": 1
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