EssilorLuxottica has announced that the U.S. Food and Drug Administration (FDA) has granted market authorization for its Essilor Stellest lens through the De Novo pathway.
The de novo classification for medical devices is a regulatory pathway for novel, moderate-risk devices to gain market approval from the US FDA when no equivalent, existing device can be identified for comparison.
The Stellest lens, designed for myopia management in children, was previously recognized by the FDA with Breakthrough Device designation in 2021. It is now the first spectacle lens to receive FDA authorization with clinical data supporting its ability to slow the progression of myopia.
According to published results, the lens slowed myopia progression by an average of 71% over two years in clinical trials. The product has already been introduced in several international markets and is expected to become available to U.S. eyecare professionals in the coming weeks.
Different Regulatory Approaches: Canada vs. U.S.
The U.S. regulatory process for myopia control lenses has been slower compared to Canada. Until now, U.S. eyecare professionals could only prescribe such lenses off label, as no product had received specific FDA approval for this indication.
In Canada, health authorities do not require additional regulatory authorization to market spectacle lenses with myopia control claims. This has led to earlier product launches and faster adoption of this lens category in Canada. Stellest was launched in Canada February 2022.
View other articles about Stellest in Optik NOW.
Click HERE for the EssilorLuxottica press release.
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