(373) Real-World Visual Outcomes by Healthcare Insurance with Prescription Digital Treatment for Amblyopia: PUPiL Registry Analysis

Background: : Amblyopia ("lazy eye") is a neurodevelopmental disorder causing reduced vision in an eye despite use of corrective lenses; it affects 2-5% of children. Previous studies show Medicaid patients with amblyopia have poorer outcomes with traditional treatments. Luminopia, an FDA-cleared prescription digital treatment for anisometropic and/or mild strabismic amblyopia in children 4 to < 13 years, may address these disparities.

Objective: : To evaluate real-world evidence, including visual outcomes and treatment adherence with Luminopia across insurance types using the Patients Using Prescription Luminopia (PUPiL) Registry (NCT06429280).

Methods: : Retrospective analysis of PUPiL registry patients < 18 years of age who completed Luminopia treatment based on data available up to 3- 4-25, including amblyopia of any cause and severity. Children enrolled had at least 12 weeks of Luminopia at 14 participating centers. Amblyopic eye best-corrected visual acuity (BCVA) improvement from start to end of treatment and treatment usage were analyzed by amblyopia severity. Multivariable analysis was used to identify significant predictors of vision improvement. Outcomes were analyzed by insurance type.

Results: : 182 Registry-enrolled children were eligible; 46% were female. Mean age was 7.3±2.5 years, 81% had received prior treatment for amblyopia, 34% had Medicaid insurance. Children with severe ( < 20/100, 14%), moderate (20/40 up to 20/100, 60%), and mild (>20/40, 25%) amblyopia gained +1.7, +1.1, and +0.3 lines BCVA, respectively. Treatment usage and duration varied by severity: mild (102±78 hours), moderate (111±76 hours), and severe (124±105 hours) over approximately 8 months for all groups. Significant predictors of improvement were prior treatment status (p=0.03), baseline vision (p < 0.0001), and treatment hours (p=0.03). After adjusting for these factors in the multivariable model, the difference in VA outcomes between insurance groups was not significant (adjusted means: Medicaid 1.3 vs. commercial 1.1 lines, p=0.40). Treatment adherence was similar between groups (Medicaid: 3.4 hr/week, 57% adherence; commercial: 3.2 hr/week, 54% adherence; p=0.48). No serious adverse events were reported.

Conclusions: : Unlike real-world outcomes observed with traditional monocular amblyopia treatments, Medicaid-insured children achieved comparable visual outcomes and treatment adherence rates to commercially-insured children using Luminopia. This therapeutic intervention may help address differences in amblyopia treatment outcomes across socioeconomic groups, potentially reducing long-term healthcare costs.

Sponsorship:: Luminopia, Inc.