Version July 2025
Macular telangiectasia type 2: Intravitreal implant: One implant surgically placed into affected eye. Note: Each Encelto implant contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotropic factor (rhCNTF) (NTC-201-6A cell line).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Ophthalmic: Conjunctival hemorrhage (31%), conjunctival hyperemia (11%), eye pain (15%), foreign body sensation of eye (15%), miosis (15%), night blindness (23%)
1% to 10%:
Immunologic: Antibody development (3%)
Nervous system: Headache (7%)
Ophthalmic: Anterior chamber inflammation (3%), blurred vision (7%), cataract (5%; including cataract traumatic, cortical cataract, nuclear cataract, subcapsular posterior cataract), dry eye syndrome (6%), eye discharge (3%), eye discomfort (9%), eye irritation (5%), eye pruritus (9%), iridocyclitis (3%), vision loss (3%), vitreous hemorrhage (9%), vitreous opacity (5%)
Hypersensitivity to endothelial serum free media (Endo-SFM), revakinagene taroretcel, or any component of the formulation; active or suspected ocular or periocular infections.
Concerns related to adverse effects:
• Cataract formation: Cataracts, including cortical, nuclear, subcapsular, traumatic, and lenticular opacities, have occurred.
• Delayed dark adaptation: A delay in vision adjustment to light (eg, adjust from bright to dim light) may occur. Advise patients to use caution while driving or navigating in the dark.
• Implant extrusion: Implant extrusion after initial scleral wound, which may manifest as recurrent uveitis, vitreous hemorrhage, eye pain especially >1-year post implantation, or visible titanium fixation loop under the conjunctiva, may occur.
• Infectious endophthalmitis: Progressive, worsening of eye pain, vision loss, or scleral and conjunctival infection consistent with infectious endophthalmitis may occur.
• Retinal tear or detachment: Retinal tear or detachment (requiring prompt evaluation) may occur. Symptoms include acute onset of flashing lights, floaters, or loss of visual field or acuity.
• Suture related: Conjunctival erosion may occur secondary to suture tips or knots.
• Vision loss: Severe vision loss, defined as loss of ≥3 lines of visual acuity, has occurred.
Concurrent drug therapy issues:
• Vitreous hemorrhage: The occurrence of temporary vision loss associated with vitreous hemorrhage may be increased in those receiving concurrent antithrombotic medications (eg, oral anticoagulants, aspirin, NSAIDs). Interruption in therapy prior to revakinagene taroretcel implantation may be necessary.
Encelto: FDA approved March 2025; availability anticipated June 2025.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Implant, Intravitreal:
Encelto: Revakinagene taroretcel-lwey 200,000 cells (1 ea)
No
Implant (Encelto Intravitreal)
200000CELLS (per each): $0.00
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Intravitreal: Revakinagene taroretcel implant insertion is a surgical procedure performed in an operating room under aseptic conditions by a qualified ophthalmologist. Refer to manufacturer's labeling for administration technique.
Macular telangiectasia type 2: Treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
None known.
There are no known significant interactions.
Adverse events were observed in some animal reproduction studies following SUBQ administration of recombinant human ciliary neurotropic factor (rhCNTF).
Following intravitreal implantation of revakinagene taroretcel, rhCNTF is secreted. Endogenous CNTF is present in maternal plasma, placental cells, and umbilical cord blood. It is not known if CNTF concentrations are increased following intravitreal implantation.
It is not known if recombinant human ciliary neurotropic factor (rhCNTF) is present in breast milk following intravitreal implantation of revakinagene taroretcel.
According to the manufacturer, the decision to breastfeed following intravitreal implantation should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Evaluate implant positioning after 6 months, then annually. Signs or symptoms of infection, retinal tear or detachment, vitreous hemorrhage, vision loss, and vision changes as clinically appropriate.
Revakinagene taroretcel 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 revakinagene taroretcel is not completely understood.
Absorption: Minimal systemic absorption (not detected in serum).
