Perspective

FDA approves ReLEx SMILE for myopia with astigmatism

The FDA has issued premarket approval for ReLEx SMILE to treat myopia with astigmatism, Zeiss announced in a press release.

The procedure, which is performed with the VisuMax femtosecond laser, may be potentially less disruptive to corneal surface tissue due to a small entry incision.

“The expansion of myopia treatment to patients with astigmatism will enable current and future SMILE surgeons to expand their patient base, paving the way for a new generation of refractive surgery patients,” Jim Mazzo, global president ophthalmic devices at Zeiss, said in the release.

The FDA has issued premarket approval for ReLEx SMILE to treat myopia with astigmatism, Zeiss announced in a press release.

The procedure, which is performed with the VisuMax femtosecond laser, may be potentially less disruptive to corneal surface tissue due to a small entry incision.

“The expansion of myopia treatment to patients with astigmatism will enable current and future SMILE surgeons to expand their patient base, paving the way for a new generation of refractive surgery patients,” Jim Mazzo, global president ophthalmic devices at Zeiss, said in the release.

    Perspective

    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.

    • John F. Doane, MD
    • Independence, Missouri

    Disclosures: Doane reports he is a consultant to Zeiss and has been paid for research overhead.