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Indian Pharma Network

ENCELTO (Revakinagene Taroretcel)

  • Medicine Name: ENCELTO
  • Active Ingredient (API): Revakinagene Taroretcel
  • Dosage Form & Strength: Intravitreal implant: one single-dose implant per eye (200,000–440,000 encapsulated cells)
  • Manufactured By: Neurotech Pharmaceuticals

Medical Uses

ENCELTO (revakinagene taroretcel-lwey), from Neurotech, is the first and only FDA-approved treatment for idiopathic macular telangiectasia type 2 (MacTel), a progressive disease that damages light-sensing cells in the macula and gradually impairs central vision. It was approved in March 2025.

ENCELTO is a small capsule surgically implanted in the eye. It contains retinal pigment epithelial cells engineered to release ciliary neurotrophic factor (CNTF) continuously, protecting photoreceptors from degeneration. In two Phase 3 trials, it significantly slowed the loss of macular photoreceptors over 24 months.

Warnings & Precautions

  • Contraindicated in eye or periocular infections and in known hypersensitivity to Endo-SFM.
  • The implant procedure has been associated with severe vision loss, infectious endophthalmitis, retinal tears/detachment, vitreous haemorrhage, implant extrusion, cataract, suture complications and delayed dark adaptation.
  • It must be implanted under aseptic conditions by a qualified ophthalmic surgeon.

Documentation & Availability

Can a patient in India receive ENCELTO?

ENCELTO is not available in India. Because it is a living-cell implant placed during eye surgery, it can only be considered in coordination with a retina surgeon and centre that can perform the implantation procedure; we discuss the practical feasibility with the treating team before any order.

How is ENCELTO supplied?

Each ENCELTO is a single-dose implant for one eye, containing 200,000 to 440,000 encapsulated cells. It is held in a sealed container attached to a gripper used during insertion, and contains no preservative.

What documents do we need?
  • A prescription from the treating retina specialist
  • Retinal imaging (OCT) report confirming macular telangiectasia type 2
  • Photo ID of the patient (Aadhaar, passport or similar), or hospital details if the hospital is placing the order

Once the prescription and OCT report are reviewed, we share the next steps and agree a timeline that fits the surgery date.

Does ENCELTO need special shipping?

Yes. The US label says ENCELTO must be kept in its shipping container (corepack) at 16–37 °C and must not be refrigerated or frozen. A temperature recorder on the pack shows whether it stayed in range; if not, it must not be used. It must also be used before the “use by” date on the pack.

Sourcing & Delivery

ENCELTO is an encapsulated cell therapy that is sensitive to temperature and has a short use-by window, so supply has to be planned around a confirmed surgery date. IPN coordinates with the manufacturer’s authorised channels and the treating centre before confirming an order.

For ENCELTO availability and cost, call +91 96548 60915 or +91 93100 90915, WhatsApp +91 98104 69557, or write to info@indianpharmanetwork.in.

Global Approval Status:

  • United States: FDA-approved in March 2025.
  • European Union / Japan: Not approved as of October 2026.

Sources:

Information last checked: November 2026.

FAQ

What is ENCELTO used for?

ENCELTO (revakinagene taroretcel) is an encapsulated cell-based gene therapy used for macular telangiectasia type 2 (MacTel).

Who manufactures ENCELTO?

ENCELTO is from Neurotech Pharmaceuticals.

How does ENCELTO work?

The implant continuously releases ciliary neurotrophic factor (CNTF), a natural nerve-support protein. According to the US label, CNTF is thought to act on supporting cells in the retina (Müller glia) and may help light-sensing cells survive; the exact mechanism is not completely understood.

Is ENCELTO an injection?

No. It is a tiny capsule implanted surgically into the eye that releases CNTF over time.

How is ENCELTO kept before surgery?

At 16–37 °C in its original shipping pack, protected from light, and never refrigerated or frozen.

Is ENCELTO approved by the US FDA?

Yes. The FDA approved ENCELTO in March 2025.

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