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Molecule

Revakinagene taroretcel

Available on requestBiologic
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Revakinagene taroretcel is a prescription medicine indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). It is available as implants for intravitreal use. MedsAcross supplies Revakinagene taroretcel for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

US FDA first approval
Not recorded
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravitreal
Dosage forms
Implant
Biologic
Yes
Identifiers
UNII Q7V7NYG6GMQ133461817

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel). ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).

Source: US FDA prescribing information

How it works

ENCELTO secretes recombinant human ciliary neurotrophic factor (rhCNTF), which is one of several neurotrophic factors endogenously produced by neurons and supporting glial cells. Exogenous CNTF is thought to initially target Müller glia to trigger a cascade of signaling events that may promote photoreceptor survival, however, the mechanism of action for ENCELTO is not completely understood.

Source: US FDA prescribing information

Dosing overview

For intravitreal implantation only. ENCELTO is intended for surgical intravitreal implantation under aseptic conditions by a qualified ophthalmologist. The recommended dose is one ENCELTO implant per affected eye containing 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF). Carefully inspect ENCELTO prior to use and refer to the Instructions for Use when preparing for and performing surgical placement or removal of ENCELTO.

Source: US FDA prescribing information

Contraindications

ENCELTO is contraindicated in patients with: Active or suspected ocular or periocular infections. Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM) Ocular or periocular infections. Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM).

Source: US FDA prescribing information

Warnings and precautions

ENCELTO implantation has been associated with severe vision loss, infectious endophthalmitis, retinal tears and/or detachment, vitreous hemorrhage, implant extrusion, cataract formation, suture related complications, and delayed dark adaptation. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required. Vitreous Hemorrhage: Temporarily discontinue antithrombotic medication prior to ENCELTO insertion surgery to reduce the risk of implantation related vitreous hemorrhage. Vitreous hemorrhages occurring greater than one year from implantation could be a sign of ENCELTO extrusion. The surgical site should be examined closely and the ENCELTO should be surgically repositioned if indicated.

Source: US FDA prescribing information

Side effects

The most common adverse reactions (incidence ≥2%) were 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.

Source: US FDA prescribing information

Storage

Store ENCELTO in the corepack at 16º to 37ºC (61º to 99ºF) until ready for use. 3. Do not freeze or refrigerate. 4.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Revakinagene taroretcel, sorted by availability.

MedicineManufacturerRegisterAvailability
Encelto 440000 units implantIntravitrealNeurotech PharmaceuticalsUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Revakinagene taroretcel available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Revakinagene taroretcel and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Revakinagene taroretcel have?

The catalogue lists 1 brand names for Revakinagene taroretcel, including Encelto.

Does Revakinagene taroretcel need cold chain shipping?

No listed presentation of Revakinagene taroretcel is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

References

  1. ENCELTO prescribing information (Neurotech Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 26 August 2026

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