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Encelto®

GoodRx

Revakinagene Taroretcel-lwey · intravitreal implant

Injections & Implants

Indication
ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
Contraindications
Active or suspected ocular or periocular infections. Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM) Ocular or periocular infections
Available Forms
Single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells.
Mechanism of Action
Mechanism of Action ENCELTO secretes recombinant human ciliary neurotrophic factor (rhCNTF), which is one of several neurotrophic factors endogenously produced by neurons and supporting glial cells.
Dosage
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).
Warnings & Precautions
  • 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 . Monitor patients for signs and symptoms of vision loss and manage as clinically indicated.
  • 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.
  • Retinal Tear and Detachment: Retinal tears and retinal detachment may occur following ENCELTO implantation. Signs and symptoms of retinal tears include acute onset of flashing lights, floaters, and/or loss of visual acuity.
  • Vitreous Hemorrhage: Vitreous hemorrhage, which may result in temporary vision loss, has occurred following ENCELTO implantation . Patients receiving antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage.
  • Implant Extrusion: Implant extrusion through the initial scleral wound has occurred following ENCELTO implantation . Signs and symptoms of implant extrusion include recurrent uveitis, vitreous hemorrhage, eye pain more than one year after implantation, or visibility of titanium fixation loop under the conjunctiva.
  • Cataract Formation: Cataract formation, including cataract cortical, cataract nuclear, cataract subcapsular, cataract traumatic, and lenticular opacities, has occurred following ENCELTO implantation .
Common 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.
Pregnancy & Lactation
Pregnancy: 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.
Lactation: There is no data on the presence of ENCELTO in human milk, its effects on the breastfed infant, or its impact on milk production.
Pediatric Use
The safety and effectiveness of ENCELTO have not been established in pediatric patients.