First Myopia Control Spectacle Lens Approved in the US

US-based optometrists who offer myopia management services will soon be able to prescribe an ophthalmic lens designed for that purpose. Earlier today, the FDA announced the approval of the Essilor Stellest lens, the first product of its kind to come to these shores. Stellest lenses have a 9mm diameter clear center surrounded by tiny “lenslets” that induce peripheral defocus. The Stellest as well as alternatives using similar optical principles are already widely used in several international markets. An EssilorLuxottica press release says the new lens will become available to US practitioners “in the coming weeks.” The Essilor Stellest lens contains over 1,000 highly aspheric “lenslets” in a series of 11 concentric rings, which induce peripheral blur to interrupt the visual signaling that contributes to axial elongation in progressive myopia.  Photo: EssilorLuxottica. The FDA decided to authorize commercialization of the Stellest based on positive results of a two-year randomized clinical trial comparing the lens to single vision correction of myopia by conventional means. Although the trial data remains as-yet unpublished, a press announcement by the FDA says the study showed a 71% reduction in spherical equivalent progression at 24 months. For axial length, the study showed a 53% reduction in eye elongation over the same period. No serious adverse events were reported but some subjects did report visual symptoms such as blur and halos. There are no labeled contraindications.The language of the FDA announcement specifies that the agency authorized marketing of the Stellest lens to correct myopia, with or without astigmatism, “and to slow the progression of the disease in children six to 12 years old at the initiation of treatment.” The lenses are to be worn “at least 12 hours per day, every day,” according to EssilorLuxottica.