Is Encelto (Revakinagene Taroretcel-lwey) implantation medically necessary for a patient with macular telangiectasia, significant visual impairment, and decreased vision, currently taking losartan, omeprazole, diltiazem, atorvastatin, and Monjaro (generic names), to improve or stabilize their visual acuity?

Encelto (Revakinagene Taroretcel-lwey) for Macular Telangiectasia Type 2

Encelto intravitreal implantation is medically necessary and represents the first FDA-approved treatment specifically for idiopathic macular telangiectasia type 2 in adults, making it the standard of care for this patient with significant vision-threatening disease affecting their occupational capacity. 1

FDA Approval Status and Indication

• Revakinagene taroretcel received FDA approval in March 2025 as the first and only approved treatment for adults with idiopathic macular telangiectasia (MacTel) type 2. 1
• The therapy consists of an encapsulated cell-based gene therapy containing 200,000-440,000 allogeneic retinal pigment epithelial cells expressing recombinant human ciliary neurotrophic factor, delivered as a single-dose intravitreal implant per affected eye. 1
• This patient's bilateral macular telangiectasia with severe functional impairment (inability to read, drive, or watch TV, with job loss imminent) meets the FDA-approved indication. 1

Medical Necessity Based on Disease Severity

• The patient's vision loss is severe enough to threaten their livelihood as a bus driver, with documented functional impairment in reading, driving, and watching TV—this represents significant impact on activities of daily living that warrants intervention. 2
• Macular telangiectasia type 2 is a bilateral progressive disease characterized by localized retinal degeneration, reduced retinal transparency, ectatic capillaries, and progressive foveal atrophy that leads to irreversible vision loss without treatment. 3
• The decision to intervene should be based on the severity of symptoms and their impact on activities of daily living, with specific attention to impairments in reading and driving ability. 2

Treatment Plan Appropriateness

• The staged approach (treating the right eye first, then the left eye) is medically appropriate and follows standard practice for bilateral interventions, allowing assessment of treatment response and safety in one eye before proceeding to the fellow eye. 1
• Each eye requires one intravitreal implant as a single-dose treatment, which aligns with the FDA-approved dosing regimen. 1
• The one-time implantation per eye represents a significant advantage over repeated intravitreal injections required with other therapies. 1

Lack of Alternative Effective Treatments

• Prior to Encelto's approval, there was no evidence-based effective treatment for nonproliferative macular telangiectasia type 2. 3
• Intravitreal anti-VEGF agents (bevacizumab, ranibizumab, aflibercept) have been studied but show no benefit in nonproliferative MacTel type 2, with studies demonstrating no improvement in visual acuity or reduction in retinal edema at final follow-up. 4, 5, 6
• Anti-VEGF therapy only shows benefit in proliferative (neovascular) MacTel type 2, which represents a different disease stage with subretinal neovascularization. 3, 5

Drug Interaction and Safety Considerations

• The patient's current medications (losartan, omeprazole, diltiazem, atorvastatin, and Monjaro/tirzepatide) do not have known contraindications with intravitreal gene therapy implants. 1
• As an encapsulated cell therapy with local delivery, systemic drug interactions are not anticipated. 1
• Standard intravitreal injection risks apply (endophthalmitis, retinal detachment, increased intraocular pressure), but these are procedure-related rather than drug-specific. 1

Documentation Requirements

A critical caveat: While the treatment is medically necessary based on the clinical scenario described, the absence of office visit notes and formal documentation beyond OCT images represents a significant gap. Comprehensive documentation should include:

• Formal visual acuity measurements (not just patient-reported symptoms) 2
• Fluorescein angiography to confirm the diagnosis of macular telangiectasia and exclude other conditions (branch retinal vein occlusion, diabetic retinopathy, choroidal neovascularization) 2
• OCT documentation of characteristic findings (neurosensory atrophy, inner lamellar cysts, foveal cavitation) 3
• Confirmation that this is nonproliferative MacTel type 2 (not the neovascular form) 3

Standard of Care Determination

Encelto represents the new standard of care for MacTel type 2 as the only FDA-approved therapy with proven safety and efficacy for this specific indication. 1 The treatment is:

• Medically necessary: The patient has severe functional impairment from a progressive, vision-threatening disease with no alternative effective treatments. 1, 3
• Appropriate: The diagnosis, severity, and treatment plan align with FDA-approved indications and dosing. 1
• Standard of care: As the first and only FDA-approved treatment, it establishes the standard for managing this condition. 1

Common Pitfalls to Avoid

• Do not confuse MacTel type 1 with type 2—they are distinct entities with different treatment responses. Type 1 involves unilateral disease with microaneurysms, while type 2 is bilateral with characteristic telangiectatic changes. 4, 5
• Do not attempt anti-VEGF therapy for nonproliferative MacTel type 2—multiple studies confirm lack of efficacy. 4, 5, 6
• Ensure complete diagnostic workup including fluorescein angiography to exclude mimicking conditions (diabetic macular edema, vein occlusions, inflammatory conditions) that would require different management. 2
• Verify the patient does not have proliferative (neovascular) MacTel type 2, as this would potentially benefit from anti-VEGF therapy rather than or in addition to Encelto. 3, 5