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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)
Available Forms
Single-dose implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells; 1 implant per container
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 include progressively worsening eye pain, vision loss, or scleral and conjunctival injection. Use proper aseptic surgical technique for ENCELTO implantation. Monitor patients for signs or symptoms of infectious endophthalmitis. Remove ENCELTO implant if infectious endophthalmitis occurs and manage symptoms according to clinical practice.
  • 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; those of retinal detachment may include progressive visual field loss and/or loss of visual acuity. Monitor for these signs or symptoms. Treat rhegmatogenous retinal detachment and retinal tears promptly. Remove ENCELTO if vitrectomy with a complete gas fill or silicone oil fill is required.
  • Vitreous Hemorrhage: Vitreous hemorrhage, which may result in temporary vision loss, has occurred following ENCELTO implantation. Patients receiving antithrombotic medication may be at increased risk, so interrupt antithrombotic medications prior to the ENCELTO implantation. Vitrectomy surgery may be necessary to clear severe, recurrent, or non-clearing vitreous hemorrhage. A late onset vitreous hemorrhage (greater than one year after implantation) calls for examining the site for possible implant extrusion.
  • Implant Extrusion: Implant extrusion through the initial scleral wound has occurred following implantation. Signs and symptoms include recurrent uveitis, vitreous hemorrhage, eye pain more than one year after implantation, or visibility of titanium fixation loop under the conjunctiva. Evaluate patients after 6 months to confirm proper positioning and then annually. If ENCELTO begins to extrude, surgically reposition ENCELTO to a proper scleral wound depth in the same site or the opposing inferior quadrant.
  • Cataract Formation: Cataract formation, including cataract cortical, cataract nuclear, cataract subcapsular, cataract traumatic, and lenticular opacities, has occurred following ENCELTO implantation. To reduce the risk of ENCELTO-related cataract formation or progression, carefully follow the specific surgical steps for ENCELTO implantation.
  • Suture Related Complications: Suture related complications, including conjunctival erosions due to suture tips and suture knots, have occurred following ENCELTO implantation. To mitigate the risk of suture related complications, carefully follow the specific surgical steps for ENCELTO implantation and manage suture-related complications as clinically indicated.
  • Delayed Dark Adaptation: A delay in the ability to adjust vision from a bright lighting condition to a dim lighting has occurred following ENCELTO administration and remained unchanged for the duration of study follow up. Advise patients to take caution while driving and navigating in the dark.
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. It is not known if the use of ENCELTO increases CNTF above naturally occurring levels in these tissues. Subcutaneous rhCNTF in pregnant rats and rabbits showed no evidence of teratogenic effects, but a decrease in implantations and live fetuses was observed in rabbits at 10ug/kg/day and a decrease in corpora lutea in rats at 100ug/kg/day.
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.