EssilorLuxottica receives FDA authorization for its Essilor Stellest lens for myopia control

The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs

EssilorLuxottica has received U.S. Food and Drug Administration (FDA) market authorization for its Essilor® Stellest® lens through the De Novo pathway. This follows its earlier recognition as a Breakthrough Technology in 2021. 

The lens is the first and only FDA-authorized spectacle lens in the U.S. designed to slow myopia progression in children, with clinical studies showing an average 71% reduction in myopia progression over two years.

The company is now looking to scale access in India, where myopia is emerging as a major public health concern. Nearly 50% of urban children in India are projected to be affected by 2050. Against this backdrop, EssilorLuxottica aims to strengthen myopia care through globally validated, FDA-authorized innovations aligned with NABH standards and evidence-based clinical practice.

EssilorLuxottica plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs such as Pune, Coimbatore, Ahmedabad, Kochi, and Chandigarh, before extending to Tier-2 and Tier-3 markets through optical professionals and education programs.

Highlighting the development, Dr Kunal Srivastava, Director – Medical & Professional Affairs, EssilorLuxottica India, said: “For decades, FDA approval has become synonymous with international standards of care in Indian medical practice. Doctors, hospitals, and patients often view FDA approval as the ultimate mark of clinical credibility. This lens technology evolves the traditional corrective lenses into a true medical treatment, and it marks the beginning of a new era for eyecare professionals in addressing myopia.”

Venu Ambati, President – India, EssilorLuxottica, said: “This is an extremely significant milestone for Essilor® Stellest® in India. It reinforces Essilor® Stellest® as the gold standard in myopia management, strengthening trust among doctors, parents, and institutions. Backed by strong clinical evidence and US FDA market authorization, Essilor® Stellest® is not just a lens—it is an investment in a child’s future eye health. At a time when myopia is emerging as a global epidemic, this innovation represents a major milestone in our Group’s mission to empower families to take proactive control of their children’s visual health.”