ENCELTO 440000 [arb'U]/1
revakinagene taroretcel-lwey · IMPLANT · Neurotech Pharmaceuticals, Inc.
Encelto is a prescription implant injected into the eye to treat a type of inherited retinal disease that causes progressive vision loss. It works by delivering gene therapy directly to the retina to help preserve or improve vision in patients with this genetic condition.
Key Facts
- Brand Name
- ENCELTO
- Generic Name
- revakinagene taroretcel-lwey
- NDC Code (Product)
82958-501- Manufacturer
- Neurotech Pharmaceuticals, Inc.
- Strength
- 440000 [arb'U]/1
- Dosage Form
- IMPLANT
- Route
- INTRAVITREAL
- Marketing Status
- Application #
- BLA125798
- Marketing Start
- 03/12/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For intravitreal implantation only. ENCELTO is intended for surgical intravitreal implantation under aseptic conditions by a qualified ophthalmologist. ( 2.1 ) 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). ( 2.1 ) Carefully inspect ENCELTO prior to use and refer to the Instructions for Use when preparing for and performing surgical placement or removal of ENCELTO. ( 2.2 , 2.3 ) 2.1 Recommended Dose For intravitreal implantation only • ENCELTO is administered by a single surgical intravitreal procedure performed by a qualified ophthalmologist. • The recommended dose is one ENCELTO implant per affected eye. Each ENCELTO implant contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line), a neurotrophic factor. 2.2 ENCELTO Surgical Placement The ENCELTO implant insertion is a surgical procedure performed in an operating room under aseptic conditions by a qualified ophthalmologist. Pre-Surgical Preparation…
Contraindications
4 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. ( 4 ) Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM). ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Neurotech at 1- 833-963-9275 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to ENCELTO in two clinical trials, Study 1 (NTMT-03-A) and Study 2 (NTMT-03-B) and are pooled for analysis. A total of 117 patients received ENCELTO, and 111 patients underwent a sham procedure and were followed for a duration of 24 months [ see Clinical St…
Frequently Asked Questions
What is ENCELTO used for?
Encelto is a prescription implant injected into the eye to treat a type of inherited retinal disease that causes progressive vision loss. It works by delivering gene therapy directly to the retina to help preserve or improve vision in patients with this genetic condition.
Is ENCELTO a controlled substance?
ENCELTO is not classified as a controlled substance by the DEA.
What is the generic name for ENCELTO?
The generic name for ENCELTO is revakinagene taroretcel-lwey. There are no other listed brand versions of revakinagene taroretcel-lwey.
What is the NDC code for ENCELTO 440000 [arb'U]/1?
The NDC (National Drug Code) for ENCELTO 440000 [arb'U]/1 is 82958-501, listed by Neurotech Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)