Written By: Riya Bhilare BPharm
Reviewed By: Pharmacally Editorial Team
On September 25, 2025, the U.S. Food and Drug Administration authorized Stellest™ spectacle lenses, the first glasses in the country specifically designed to slow the progression of childhood myopia, also known as nearsightedness. These lenses, developed by Essilor of America, part of EssilorLuxottica, are indicated for children between 6 and 12 years old at the start of treatment.
Stellest lenses not only correct vision but also reduce how quickly myopia worsens. They use a patented design HALT (Highly Aspherical Lenslet Target) with a clear central zone for normal vision and over 1,000 tiny lenslets arranged in concentric rings around it. This optical pattern shifts the way light is focused in the eye, creating what is called “peripheral myopic defocus.” Clinical research suggests this signal slow down excessive eye growth, which is the main cause of progressive myopia.
The FDA decision was based on results from a pivotal two-year randomized clinical trial (CYPRESS NCT03623074). In this study, children wearing Stellest lenses showed a 71% reduction in myopia progression and a 53% reduction in axial elongation (eye growth) compared to children using standard single-vision lenses. In practical terms, that meant about 0.80 diopters less worsening of vision and roughly 0.35 mm less eye growth over two years. These results are considered clinically meaningful and place Stellest among the most effective optical interventions for myopia control. It was observed that no serious side effects were linked to the lenses. Some children experienced temporary blur or halos while adapting, but these symptoms were generally mild and resolved over time. The FDA granted De Novo marketing authorization for Stellest, creating a new Class II device category for glasses that slow myopia progression.
Until now, the only FDA-approved option for myopia control in children was the MiSight® 1 day contact lens, cleared for use in children aged 8–12. Stellest expands the treatment options by offering a glasses-based solution suitable for children as young as six. This is particularly valuable for families who prefer spectacles over contact lenses or for younger children not ready for contact lens use. Compared with other therapies such as low-dose atropine eye drops or lifestyle measures like more outdoor time, Stellest provides a noninvasive, easy-to-use, and evidence-backed alternative that fits into everyday life.
FDA’s Dr. Michelle Tarver Director, Center for Devices and Radiological Health, noted that Stellest offers a treatment option that may reduce the risk of serious vision problems later in life while being easier and safer than existing myopia-control devices. EssilorLuxottica Chairman & CEO Francesco Milleri and Deputy CEO Paul du Saillant described the lens as a long-awaited innovation that turns traditional corrective eyewear into a true medical treatment, marking a new era for eyecare. Norbert Gorny, the company’s R&D chief, added that the lens represents an important milestone in the fight against the global myopia epidemic.
EssilorLuxottica plans to make Stellest available to U.S. eye care professionals soon, with training and guidance to support prescribing. While long-term data are still being collected, studies up to six years suggest the benefits are durable. For families and physicians, Stellest represents an important new tool in managing myopia, offering children a safer and more convenient way to preserve better vision as they grow.
References
FDA Authorizes Marketing of First Eyeglass Lenses to Slow Progression of Paediatric Myopia, USFDA, 25 September 2025, https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-first-eyeglass-lenses-slow-progression-pediatric-myopia
Essilor Stellest is the first and only FDA market authorized spectacle lens in the United States, 25 September 2025, EssilorLuxxotica, https://www.essilorluxottica.com/en/newsroom/press-releases/essilor-stellest-fda/
Control of Myopia Using Novel Spectacle Lens Designs (CYPRESS), ClinicalTrials.gov ID NCT03623074, https://clinicaltrials.gov/study/NCT03623074
National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Board on Behavioral, Cognitive, and Sensory Sciences; Committee on Focus on Myopia: Pathogenesis and Rising Incidence. Myopia: Causes, Prevention, and Treatment of an Increasingly Common Disease. Washington (DC): National Academies Press (US); 2024 Sep 17. 7, Current and Emerging Treatment Options for Myopia. https://www.ncbi.nlm.nih.gov/sites/books/NBK607613/