“Does it work, how well, and is it worth covering?” Dr. Maanasa Indaram and Stephanie Roberts walk through the clinical trial and real-world evidence behind Luminopia, the FDA-authorized treatment for pediatric amblyopia.

Amblyopia is the leading cause of preventable vision loss in children, and standard-of-care treatment — patching the non-amblyopic eye — is hard on kids and families and leaves many with persistent amblyopia even after treatment. With that quick refresher in mind, this session turns to the evidence: does Luminopia work, how well, and is it worth covering?

We’ll briefly walk through the clinical development program, from pilot study through the pivotal Phase 3 RCT (Xiao et al., Ophthalmology 2021), before spending most of the session on real-world evidence from the PUPiL Registry. We’ll dig into registry outcomes across key subgroups — previously treated patients, older children, severe amblyopia, and by insurance/coverage type — along with durability of treatment effect after completion. We’ll close with health equity and access: real-world standard-of-care outcomes by insurance status, the uncovered cost burden of patching for Medicaid families, and cost-effectiveness data.

Learning Objectives

• Get a quick refresher on amblyopia and the standard of care, and where it falls short for Medicaid-covered kids and families
• Recognize health equity and access gaps in real-world standard-of-care outcomes by insurance status, and review budget impact
• Briefly review the clinical development program and pivotal Phase 3 RCT results (Xiao et al., Ophthalmology 2021)
• Dive into real-world evidence from the PUPiL Registry, including outcomes for previously treated patients, older children, severe amblyopia, and by insurance/coverage type, and durability after treatment completion
• Preview emerging coverage considerations for health plans, including state Medicaid fee schedules and JMCP recommendations

Speakers

• Maanasa Indaram, MD, Associate Professor of Ophthalmology and Medical Director, Pediatric Ophthalmology and Adult Strabismus, University of California, San Francisco
• Stephanie Roberts, Head of Market Access, Luminopia, Inc.