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DTSTART;TZID=America/New_York:20260901T140000
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SUMMARY:“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.
DESCRIPTION: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? \nWe’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. \nLearning Objectives \n\nGet a quick refresher on amblyopia and the standard of care\, and where it falls short for Medicaid-covered kids and families\nRecognize health equity and access gaps in real-world standard-of-care outcomes by insurance status\, and review budget impact\nBriefly review the clinical development program and pivotal Phase 3 RCT results (Xiao et al.\, Ophthalmology 2021)\nDive 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\nPreview emerging coverage considerations for health plans\, including state Medicaid fee schedules and JMCP recommendations\n\n  \nSpeakers \n\nMaanasa Indaram\, MD\, Associate Professor of Ophthalmology and Medical Director\, Pediatric Ophthalmology and Adult Strabismus\, University of California\, San Francisco\nStephanie Roberts\, Head of Market Access\, Luminopia\, Inc.\n\n \n  \n \nRegister Now
URL:https://medicaidplans.org/event/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-authoriz/
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