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Revakinagene Taroretcel-Lwey

FDA Drug Information • Also known as: Encelto

Brand Names
Encelto
Route
INTRAVITREAL
Dosage Form
IMPLANT
Product Type
HUMAN PRESCRIPTION DRUG

Description

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. 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 ( Figure 17 ). 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.

What Is Revakinagene Taroretcel-Lwey Used For?

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).

Dosage and Administration

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 ) 2.1 Recommended Dose For intravitreal implantation only

  • ENCELTO is administered by a single surgical intravitreal procedure performed by a qualified ophthalmologist.
  • The recommended dose is one ENCELTO implant per affected eye. Each ENCELTO implant contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor (rhCNTF) (NTC-201-6A cell line), a neurotrophic factor. 2.2 ENCELTO Surgical Placement The ENCELTO implant insertion is a surgical procedure performed in an operating room under aseptic conditions by a qualified ophthalmologist. Pre-Surgical Preparation Inspect the ENCELTO packaging for any signs of damage or leakage. Verify the use-by date. Confirm that the disposable temperature recording device displays a checkmark at the top of the screen. Ensure the liquid medium is at the correct pH using the provided pH color guide reference card. Prepare the surgical field properly. Surgical Steps 1. Preparing the Surgical Site a. Create a 7x7 mm peritomy of the conjunctiva and Tenon’s capsule at the selected implantation site. b. Place a corneal-limbal traction suture in the selected surgical quadrant (either inferotemporal or inferonasal) ( Figure 1 ). c. Maintain hemostasis of the underlying sclera and conjunctiva ( Figure 1 ). d. Using an MVR and 15-degree blade, create a 3.0 mm full-thickness sclerotomy 3.75 mm posterior and parallel to the limbus ( Figure 2 ). Do not insert ENCELTO outside of the pars plana. e. Confirm:
  • The incision is full thickness.
  • There is adequate hemostasis.
  • There is no spanning uveal tissue. 2. Preparing the ENCELTO Implant a. Open the inner container and expose the upper compartment and luer lock cap ( Figure 3 ). b. Unlock the luer lock cap by turning it counterclockwise once. c. Lift the luer lock cap vertically to remove ENCELTO (attached to the gripper). d. Rinse ENCELTO with at least 5 mL of sterile Balanced Saline Solution (BSS). e. Keep ENCELTO moist by applying BSS every 10 minutes until insertion. f. While holding the luer lock cap, pass a double-armed 9-0 polypropylene suture needle through ENCELTO’s fixation loop ( Figure 4 ). 3. Implantation of ENCELTO a. Gently open the sclerotomy incision and insert ENCELTO perpendicularly into the eye ( Figure 5 ). b. Ensure only the fixation loop is exposed. c. Release ENCELTO from the gripper by squeezing the indicated region with forceps...

    • Side Effects (Adverse Reactions)

    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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflects exposure to ENCELTO in two clinical trials, Study 1 (NTMT-03-A) and Study 2 (NTMT-03-B) and are pooled for analysis. A total of 117 patients received ENCELTO, and 111 patients underwent a sham procedure and were followed for a duration of 24 months [ see Clinical Studies (14) ]. Serious adverse reactions occurred in six patients (5%) including suture related complications (n=5) and implant extrusion (n=1). Table 1 lists the most common adverse reactions that occurred in > 2% patients and with higher frequency in ENCELTO group compared to Sham group in Study 1 and Study 2. Table 1. Adverse Reactions occurring in ≥2% of Patients and with higher frequency in ENCELTO group compared to Sham group in ENCELTO studies* Adverse Reactions ENCELTO (N=117) n (%) Sham (N=111) n (%) Conjunctival hemorrhage 36 (31) 29 (26) Delayed dark adaptation 27 (23.1) 1 (1) Foreign body sensation in eyes 18 (15) 15 (13.5) Eye pain 18 (15) 10 (9) Suture related complication** 18 (15.4) 3 (2.7) Miosis 18 (15.4) 0 (0.0) Conjunctival hyperemia 13 (11) 9 (8) Eye pruritus 10 (9) 4 (3.6) Ocular discomfort 10 (9) 1 (1) Vitreous hemorrhage 10 (8.5) 0 (0.0) Vision blurred 8 (7) 4 (4) Headache 8 (7) 1 (1) Dry eye 7 (6) 2 (2) Eye irritation 6 (5.1) 2 (2) Cumulative cataract incidence 6 (5) 0 (0) Vitreous floaters 6 (5) 0 (0.0) Severe visual loss>15 letters*** 4 (3) 0 (0) Eye discharge 4 (3.4) 1 (0.9) Anterior chamber cell 4 (3.4) 0 (0.0) Iridocyclitis 3 (2.6) 0 (0) * Pooled data from Study 1 and Study 2; Adverse reaction rates were comparable between the two studies **Suture related complications include exposed suture, foreign body sensation, conjunctival wound dehiscence, painful sutures, suture irritation, suture granuloma, scleral wound opening, and itchy suture *** Includes one case of visual loss due to cataract formation which remained unresolved at the end of the study

    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 )

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied ENCELTO is supplied as a sterile, single-dose, implant that contains 200,000 to 440,000 allogeneic retinal pigment epithelial cells expressing rhCNTF (NTC-201-6A cell line). ENCELTO is packaged in a protective inner container within an Endothelial Serum Free Media (Endo-SFM), which is maintained sterile by a sealed outer container. ENCELTO is provided attached to a gripper that both suspends ENCELTO in the Endo-SFM and facilitates intraocular insertion. ENCELTO contains no preservatives. NDC: 82958-501-01 See Table 4 , ( Figure 16 ) and ENCELTO “Instructions for Use” for additional details. Table 4. ENCELTO Corepack Contents Components Description Inner container This is provided sterile. It is a cylindrical plastic container with a lower compartment filled with liquid medium. It has an upper compartment connected to it via a narrow channel that is secured shut with a luer lock cap. Outer container This is a plastic container with a foil lid hermetically sealed. It maintains the sterility of the inner container until ready to use. Disposable temperature recording device A disposable device that measures and records the temperature in the package. If ENCELTO has been stored within the acceptable range, a “✓” will be shown at the top of the screen. If an “X” is displayed, ENCELTO has been exposed to temperatures outside of the acceptable range and must not be used. ENCELTO Medium pH Color Guide A card that provides a color scale to indicate the acceptable pH range for the liquid medium. ENCELTO Instructions for Use A booklet that contains the full instructions and includes the ENCELTO patient card. ENCELTO Inspection Checklist An information sheet that contains instructions for inspection prior to use. USPI United States Prescribing Information. Figure 16. ENCELTO Corepack Contents Figure 17. ENCELTO Figure 18. ENCELTO Inner Container Figure 19. pH Color Guide image description image description image description...

    About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.