Brand Name
Encelto
Generic Name
Revakinagene Taroretcel-Lwey
View Brand Information FDA approval date: March 12, 2025
Form: Implant
What is Encelto (Revakinagene Taroretcel-Lwey)?
ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 . ENCELTO is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2 .
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Brand Information
1INDICATIONS AND USAGE
ENCELTO is indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).
2DOSAGE FORMS AND STRENGTHS
ENCELTO is a single-dose implant 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 intravitreal surgical placement. ENCELTO is an opaque semi-permeable capsule that is white to off-white, capped on both ends, and has a titanium loop on one end. The ENCELTO width is 1.2 ± 0.1 mm, its length is 6.1 ± 0.4 mm, and its internal diameter is 0.88 ± 0.02 mm (
3CONTRAINDICATIONS
ENCELTO is contraindicated in patients with:
- Active or suspected ocular or periocular infections.
- Known hypersensitivity to Endothelial Serum Free Media (Endo-SFM)
4DESCRIPTION
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.
ENCELTO consists of an opaque, semi-permeable white to off-white capsule surrounding a scaffold of polyethylene terephthalate (PET) yarn, loaded with rhCNTF secreting allogeneic retinal pigment epithelial cells (NTC-201-6A cell line). Each end of the semi-permeable capsule is sealed with medical grade methacrylate adhesive, and to one end a titanium fixation loop is attached. ENCELTO width is 1.2 ± 0.1 mm, length is 6.1 ± 0.4 mm, and its internal diameter is 0.88 ± 0.02 mm (
ENCELTO is packaged in a protective inner container within an orange to pink liquid hold medium referred to as Endothelial Serum Free Media (Endo-SFM), which is maintained sterile by a sealed outer container. ENCELTO is provided attached, by the fixation loop, to a gripper that both suspends ENCELTO in the Endo-SFM and facilitates intraocular insertion. The Endo-SFM within the packaging inner container may contain visible particles generally described as fiber, solid, white, or metallic in appearance.
ENCELTO is manufactured using animal and human derived reagents.
5CLINICAL STUDIES
The efficacy of ENCELTO was evaluated in two studies, Study NTMT-03-A (
Study 1
Study 1 was a randomized, multi-center, sham-controlled study which enrolled adults with MacTel. For enrollment, the patients were required to have a photoreceptor inner segment/outer segment (IS/OS PR) break (loss) in ellipsoid zone (EZ) between 0.16 and 2.00 mm
A total of 120 patients were randomized and of these, 115 patients (ENCELTO group: 58; Sham group: 57) comprise the efficacy analysis population. The demographic characteristics of the efficacy analysis population were as follows: the mean age was 61 years (range 40 to 78 years), 79 patients (69%) were female, 98 patients (85%) were White, 5 patients (4%) were Asian, 3 patients (3%) were Black or African American, 1 patient (1%) was American Indian, and 8 patients (7%) were of “other” race. Six patients (5%) were Hispanic. The median (min, max) baseline EZ area loss was 0.35 (0.15, 1.99) mm
The primary efficacy outcome measure was the rate of change in the area of EZ loss (IS/OS, macular PR loss) over 24 months, as measured by SD-OCT. The secondary outcome measure was the mean change in aggregate sensitivity loss of microperimetry within the EZ break area from baseline to Month 24.
The efficacy outcome results for Study 1 are summarized in
CI = confidence interval, EZ=ellipsoid zone
a Estimated by using a longitudinal mixed model including EZ area loss as the dependent variable, patient-specific random intercepts, treatment group, time (continuous), and interaction between treatment and time as covariates. The baseline and Months 12, 16, 20, and 24 visits were included.
b Estimated by using two-sample t-test; seven ENCELTO and four Sham patients were excluded due to missing data.
c Statistically significant at two-sided alpha of 0.05.
Study 2
Study 2 was a randomized, multi-center, sham-controlled study which enrolled adult with MacTel. For enrollment, the patients were required to have an IS/OS PR break in EZ between 0.16 and 2.00 mm
Patients were randomized to receive either ENCELTO intravitreal implant or sham procedure under standard peri-operative procedures. Patients in ENCELTO group underwent conjunctival peritomy, implant placement in the vitreous cavity via sclerotomy and closure with sutures. Patients in the Sham group underwent conjunctival peritomy, scleral pressure, and conjunctival closure with sutures. One hundred and thirteen (95%) of the 119 patients underwent the assigned procedure and were included in efficacy evaluation.
A total of 119 patients were randomized and of these, 113 patients (ENCELTO group: 59; Sham group: 54) comprise the efficacy analysis population. The demographic characteristics of the efficacy analysis population were as follows: the mean age was 59 years (range: 40 to 75 years), 82 patients (73%) were female, 102 patients (90%) were White, 4 patients (4%) were Asian, and 7 patients (6%) were of “other” race or “unable to specify” race. Eight patients (7%) were Hispanic. The median (min, max) baseline EZ area loss was 0.48 (0.16, 1.63) mm
The primary efficacy outcome measure was the rate of change in the area of EZ loss (IS/OS, macular PR loss) over 24 months, as measured by SD-OCT. The secondary outcome measure was the mean change in aggregate sensitivity loss of microperimetry within the EZ break area from baseline to Month 24.
The efficacy results from Study 2 are summarized in
CI = confidence interval, EZ=ellipsoid zone
a Estimated by using a longitudinal mixed model including EZ area loss as the dependent variable, patient-specific random intercepts, treatment group, time (continuous), and interaction between treatment and time as covariates. The baseline and Months 12, 16, 20, and 24 visits were included.
b Estimated by using two-sample t-test; Seven ENCELTO and six Sham patients were excluded due to missing data.
c Statistically significant at two-sided alpha of 0.05.
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Discuss the following with the patient.
Advise patients that ENCELTO implantation may be associated with infectious endophthalmitis (eye infection), retinal tear and detachment (retina separates from the eye wall resulting in vision loss), vitreous hemorrhage (bleeding within the central cavity of the eye), implant extrusion, suture-related complications, cataract formation (clouding of the lens of the eye), severe vision loss, and delayed dark adaptation (ability of the eye to adjust from bright lighting conditions to dark lighting conditions) [
Instruct patients to seek immediate care from an ophthalmologist if they experience any signs or symptoms that could be associated with these events which may include the following:
- An increase in floaters, the appearance of “spider webs”, flashing lights, sensitivity to light, or loss of vision or visual field;
- Increasing eye pain, progressive redness in the white of the eye, a sudden sensation that something is in their eye (i.e., foreign body sensation) or eye discharge.
Advise patients that they may temporarily experience the following after ENCELTO implantation:
- Mild sensation of something in the eye (i.e., foreign body sensation)
- Eye redness, irritation, pain or discomfort, or dryness
- Blurred vision or floaters
Advise patients that delayed dark adaptation may be experienced for the length of time that ENCELTO is surgically placed [
- Driving: delayed dark adaptation may impair one's ability to see objects, pedestrians, or road signs when moving rapidly from a brightly lit environment to a dimly lit environment (for example, entering a tunnel during the daytime).
- Navigating in the dark: Advise caution when moving from bright to dark areas, such as entering a dark room or stepping outside at dusk. Consider using flashlights, nightlights, or motion-activated lighting at home.
- Consider wearing sunglasses or tinted lenses in bright environments to reduce the impact of transitioning from light to dark.
Magnetic Resonance (MR) Conditional Information
ENCELTO is MR conditional. Advise patients that they have ENCELTO implanted in their eye and provide the patient with their implant card should they require Magnetic Resonance Imaging (MRI).
Driving and Using Machines
- Advise patients to not drive or use machinery until the eye shield has been removed and their ophthalmologist informs them that their vision has recovered to an acceptable level.
Postoperative Care
Advise patients on the following post operative care:
- Avoid heavy lifting (over 20 pounds) for one week.
- Keep water out of the eye (e.g., close eye while showering) for one week.
- Protect eyes by wearing glasses or protective eyewear during the day and using an eye shield at night for one week.
- Use a topical antibiotic solution at a frequency of 1 drop four times a day for 7 days.
- Use a steroid drop taper of prednisolone acetate 1% (or equivalent) starting the day after surgery with the following taper:
Manufactured by:
Neurotech Pharmaceuticals, Inc.
Building 1, Suite 101
Cumberland, RI 02864
U.S. license number: 2321
7Instructions for Use
8ENCELTO PRODUCT LABEL
9ENCELTO COREPACK LABEL
