FDA Clears First Eyeglass Lenses to Mitigate Pediatric Myopia Progression

Essilor Stellest eyeglass lenses have received FDA authorization to slow myopia progression in children — the first spectacle-specific regulatory clearance for pediatric myopia control.

The authorization creates a lower‑risk, noninvasive outpatient option for younger children and for those who cannot tolerate contact lenses and may be adopted into pediatric eye‑care pathways as practices assess local use. Given that myopia often progresses during school years and raises lifetime risk of sight‑threatening complications, this device fills an important gap in early-stage management.

A pivotal randomized controlled trial over 24 months showed a 71% reduction in refractive myopia progression versus single‑vision control lenses, with axial length change reduced by approximately 53% at 24 months. Primary endpoints included spherical equivalent refraction and axial length; single‑vision spectacles served as the comparator across the 24‑month follow-up. These effect sizes represent a clinically meaningful benefit compared with standard single‑vision lenses.

No serious adverse events were reported; the observed effects were limited to transient visual symptoms such as brief blur and halos. Labeled indications note initiation between ages 6 and 12, with specific mention of applicability for younger children (ages 6–7) and for those unable or unwilling to use contact lenses. The safety profile is favorable relative to contact‑lens–based options because spectacle wear avoids contact‑related infection risks. Counseling should include discussion of transient symptoms and routine monitoring during the adaptation period.

The lenses use a peripheral defocus design with concentric rings of small raised lenslets that shift peripheral focus toward the retinal periphery while preserving central clarity. This optical configuration is intended to reduce the stimulus for axial elongation and provides a plausible mechanistic rationale consistent with the observed reductions in axial length and refractive progression at two years, without extending claims beyond the trial findings.

Baseline assessment for candidate selection should include visual acuity, cycloplegic refraction, and axial length where available. Reasonable follow‑up cadence includes checks at roughly 3–6 months, 12 months, and 24 months to document refractive and axial changes.

Operational integration involves selecting at‑risk children, verifying fit and central clarity at dispensing, documenting baseline metrics, scheduling the follow‑up cadence, and planning spectacle ordering and local coverage pathways tied to regulatory status. As practices incorporate this option, it can be offered alongside other myopia‑control interventions for appropriate patients.

Key Takeaways:

• A spectacle lens received FDA authorization specifically to slow pediatric myopia progression based on two‑year randomized trial evidence, adding a noncontact option for myopia control.
• Children initiated on treatment between ages 6 and 12 — including younger children who cannot wear contact lenses — are primary candidates for this spectacle option.
• Practices will likely add this spectacle option alongside existing interventions and implement baseline and periodic monitoring protocols to track refractive and axial outcomes.