Recommendations for use and coverage of digital, binocular treatments for amblyopia

Amblyopia is the most common cause of vision impairment in children and presents as reduced visual acuity caused by suppression of neurologic signals from an eye. Traditional treatments include penalizing the better-seeing eye by occlusion, most commonly with patching. This does not address the binocular vision deficits of amblyopia and leaves most patients with unresolved disease and permanent vision loss. Digital, dual-acting therapy (Luminopia, Luminopia, Inc) was cleared in October 2021 via US Food and Drug Administration de novo market authorization for the treatment of amblyopia associated with anisometropia and/or with mild strabismus in children aged 4-7 years. Binocular digital therapy is now included in the American Academy of Ophthalmology's amblyopia treatment guidelines, the Amblyopia Preferred Practice Pattern (PPP). The pivotal randomized, controlled phase 3 trial evaluating Luminopia was recognized in the PPP as Level I+ evidence. Pediatric ophthalmologists and national and regional health plan leaders formed a roundtable panel to evaluate disease impact, the current treatment landscape, and guideline-based treatment principles. At the conclusion of this discussion, the panel developed a unanimous recommendation for the appropriate clinical and value-driven use of Luminopia and payer coverage recommendations. Luminopia is recommended for use to treat amblyopia and should be covered by payer policies. Duration of therapy should be based on patient needs as determined by prescribing physician expertise. Luminopia may be covered under either medical or pharmacy benefit. Step-edits may be used, and documentation of inadequate response to other therapies may be necessary to obtain coverage. Clinical documentation and medical letters of exception may also be needed for off-label use of Luminopia. The recommendations achieved in this roundtable based on the clinical evidence available provide a justification for broad payer coverage and improved patient access to a full range of evidence-based amblyopia treatments.