(170) A Novel Low-dose Atropine Eye Drop Slows the Progression of Pediatric Myopia: Evidence from the STAR Study

Background: : Pediatric myopia is a chronic, progressive disease affecting an estimated 27 million children in the United States. Earlier-onset cases are associated with faster progression to moderate or severe myopia and greater risk of complications, including retinal detachment, myopic maculopathy, and glaucoma. There are currently no FDA- approved pharmacologic treatments to slow myopia progression in children, underscoring the need for evidence-based strategies that address the underlying disease process and reduce comorbidities.

Objective: : To evaluate long-term myopia progression and treatment outcomes in children enrolled in the STAR study who were treated for 3 years with a novel low-dose atropine formulation.

Methods: : STAR is a 36-month, multicenter, randomized, double-masked, vehicle-controlled study evaluating SYD-101, an investigational low-dose atropine eye drop formulation, in children aged 3-14 years with myopia between -0.50 and -6.00 diopters (D). A total of 847 participants were randomized 1:1:1 to receive 0.01%, 0.03%, or vehicle, administered nightly in both eyes. Safety was assessed through standard ocular examinations and patient-reported tolerability questionnaires.

Results: : Among 847 randomized participants, significantly fewer children treated with 0.01% experienced myopia progression worse than -0.75 diopters (D) over 36 months (primary endpoint) compared with those receiving vehicle (p=0.0226) in the ITT population. Treatment effects were observed as early as Month 12 and were sustained through Month 36. Mean myopic annual progression rate at Month 36 (secondary endpoint) was significantly less in the 0.01% treated group compared with that in the vehicle group (p=0.0002) and time-to-progression of worse than -0.75D at Month 36 was also significantly reduced (p=0.007). Additional sub-groups demonstrated even greater benefits from SYD-101. The treatment was well tolerated, with no unexpected adverse events reported.

Conclusions: : Pediatric myopia progresses predictably and increases the risk of irreversible ocular complications. In a large, diverse population, data from the STAR study demonstrate statistically significant and clinically meaningful benefits from treatment with SYD-101. These data support the need for early disease-modifying treatment and may help inform future payer considerations, pending regulatory review of SYD-101. SYD-101 is investigational and not approved by the U.S. Food and Drug Administration.

Sponsorship:: Sydnexis, Inc.