Overview
11 DESCRIPTION ENCELTO (revakinagene taroretcel-lwey) implant, is single-dose, sterile, nonpyrogenic and retrievable. ENCELTO is an allogeneic encapsulated cell-based gene therapy that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line) for surgical intravitreal placement.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 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. 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. 12.3 Pharmacokinetics Systemic exposure of rhCNTF was measured in 2 distribution studies in rabbits and in 2 toxicology studies in minipigs. Overall, there was no evidence of systemic exposure to rhCNTF after implantation of ENCELTO in rabbits for periods up to 9 months or in minipigs for periods of up to 6 months.
Indications
- 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).
Common Doses
- 5 mL
- 2 mg
- 0.5 ml
- 4 mg
Dosage
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.
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 )
Side Effects
- 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.
Interactions
- No major interactions listed on the FDA label. Always consult a healthcare professional.