FDA approves ReLEx SMILE for myopia with astigmatism

John F. Doane, MD

The FDA approval of spherocylindrical SMILE is a wonderful milestone for patients in the US. The Zeiss FDA investigation team and study sites did a fantastic job in the trial. SMILE as a procedure has many attributes that patients can benefit from, including a small incision, quick recovery, optimal corneal biomechanical strength, and minimal corneal nerve interruption and dry eye postoperatively. The refractive results of the study showed the myopic spherocyclindrical SMILE outcomes to be as good as the state-of-the-art modern LASIK results, which is a phenomenal achievement. With technique optimization we have learned from international surgeons performing SMILE, I anticipate our post-approval results will exceed even the FDA trial data, which is exciting. Now U.S. surgeons can be on par with the rest of the world in offering the latest technology for patients seeking an alternative to glasses and contacts. The latest range of treatment approved should expand the potential patients treated from 30% to over 80% of the population seeking vision correction surgery. This approval provides an incredible opportunity for those patients with compound myopic astigmatism to benefit from SMILE.