Dr Mark Bullimore weighs in on recent FDA marketing authorization of Stellest lenses

During EyeCon 2025, Mark Bullimore, MCOptom, PhD, FAAO, commented on the recent significant US Food and Drug Administration (FDA) announcement regarding the marketing approval of a new myopia control technology for children in the United States. The FDA authorized marketing of the Essilor Stellest eyeglass lenses for the correction of myopia with or without astigmatism last week, which works to slow the progression of myopia in children aged 6-12 at the initiation of treatment.

The FDA has approved a new Stellest lens technology with highly aspherical lens design. This lens is only the second such approval in the field of myopia control for children. The approval marks a notable milestone in pediatric vision correction, according to Bullimore.

Additionally, he noted that the approval introduces spectacle-based myopia control to the US, which is a more accessible and familiar option compared to contact lenses. Spectacles also allow for earlier intervention in children's myopia progression. The technology represents an alternative to contact lens-based myopia management, Bullimore said.

He believes that the approval provides a new, potentially easier entry point for managing childhood myopia, with spectacles potentially enabling treatment for younger children who are not yet ready for contact lenses.Ultimately, the technology offers another tool for eye care professionals in managing myopia progression

Eagerly awaiting further clinical trial results, Bullimore hopes that the Summary of Safety and Effectiveness Data (SSED) will be to be available on the FDA website in the next week, which he hopes will provide more comprehensive insights into the technology, its effectiveness, and the basis for FDA approval. This will help professionals better understand and potentially implement this new myopia control approach.