Revakinagene Taroretcel

Mechanism-of-action classes: Gene Editing or Modification; Unknown Cellular or Molecular Interaction.

• 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).

• 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.contraindicated

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 Inspect the ENCELTO packaging for any signs of damage or leakage. Verify the use-by date. Confirm that the disposable temperature recording device displays a checkmark at the top of the screen. Ensure the liquid medium is at the correct pH using the provided pH color guide reference card. Prepare the surgical field properly. Surgical Steps 1. Preparing the Surgical Site a.

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. ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 ) 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. ( 5.4 ) 5.1 Severe Vision Loss Severe vision loss defined as three or more lines of visual acuity loss [≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters] has occurred following ENCELTO implantation [ see Adverse Reactions (6) ]. Monitor patients for signs and symptoms of vision loss and manage as clinically indicated. 5.2 Infectious Endophthalmitis Infectious endophthalmitis may occur following ENCELTO implantation. Signs and symptoms of infectious endophthalmitis include progressively worsening eye pain, vision loss, or scleral and conjunctival injection. To mitigate the risk of endophthalmitis, use proper aseptic surgical technique for ENCELTO implantation [ see Dosage and Administration (2.2) ].

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 Studies (14) ]. Serious adverse reactions occurred in six patients (5%) including suture related complications (n=5) and implant extrusion (n=1). Table 1 lists the most common adverse reactions that occurred in > 2% patients and with higher frequency in ENCELTO group compared to Sham group in Study 1 and Study 2. Table 1.

8.1 Pregnancy Risk Summary There are no data on the use of ENCELTO in pregnant women. Endogenous CNTF is naturally found in maternal plasma, placental cells, and umbilical cord blood. It is not known if the use of ENCELTO increases CNTF above naturally occurring levels in these tissues. In animal reproduction studies, subcutaneous administration of rhCNTF to pregnant rats and rabbits demonstrated no evidence of teratogenic effects on the fetus. However, when administered to rabbits at a dose level of 10ug/kg/day, a decrease in implantations and live fetuses was observed. When administered to rats at a dose level of 100ug/kg/day a decrease in corpora lutea was observed. The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. Data Animal Data See Risk Summary for details on data . 8.2 Lactation Risk Summary There is no data on the presence of ENCELTO in human milk, its effects on the breastfed infant, or its impact on milk production.

1. 1Blindness Unilateral120%
2. 2Depression120%
3. 3Eye Pain120%
4. 4Limb Injury120%
5. 5Macular Detachment120%
6. 6Ocular Discomfort120%
7. 7Ocular Procedural Complication120%
8. 8Suicidal Ideation120%
9. 9Visual Impairment120%
10. 10Vitreoretinal Traction Syndrome120%
11. 11Vitreous Haemorrhage120%

The 1 most recently updated of 1 ClinicalTrials.gov registrations naming Revakinagene Taroretcel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Phase 4 Study: Long-term Safety and Efficacy of NT-501 in MacTel Type 2, Including Sham Procedure Participants
  Recruiting · Phase 4 · Interventional · 285 enrolled · Neurotech Pharmaceuticals
  NCT06971939updated 2026-06-01

Frequently asked questions

How does Revakinagene Taroretcel work?

Mechanism-of-action classes: Gene Editing or Modification; Unknown Cellular or Molecular Interaction.

What is Revakinagene Taroretcel used for?

According to FDA labeling, Revakinagene Taroretcel carries indications including: 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Revakinagene Taroretcel?

Revakinagene Taroretcel is classified as Gene Editing or Modification, Unknown Cellular or Molecular Interaction.

What are the brand names for Revakinagene Taroretcel?

Revakinagene Taroretcel is marketed under brand names including Encelto.

What are the contraindications for Revakinagene Taroretcel?

Revakinagene Taroretcel labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.