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HomeminewsSMILE Approved by FDA For Myopia Treatment in US

SMILE Approved by FDA For Myopia Treatment in US

Small incision lenticule extraction (SMILE) has received U.S. Food and Drug Administration (FDA) approval, five years after its commercial introduction in September 2011.1

According to Zeiss, the company behind SMILE technology, more than half a million SMILE procedures have been performed worldwide and refractive surgeons are continuing to transition to the procedure.

“For the last five years, the popularity of SMILE with surgeons and patients outside of the US has continued to grow,” said Jim Mazzo, Global President of Ophthalmic Devices, and President and CEO of the company’s U.S. organisation. “With the FDA approval of the VisuMax SMILE procedure, U.S. surgeons now have a new premium laser eye surgery option for their practice and can offer the benefits of SMILE to their patients.”
SMILE, a minimally-invasive corneal refractive procedure for myopia performed on the VisuMax femtosecond laser platform (Carl Zeiss Meditec, Jena, Germany, is currently available in approximately 500 clinics in 61 countries around the world.

The recent FDA approval was based on results of a pivotal study2 which demonstrated excellent visual acuity and refractive predictability outcomes for the 336 eyes treated at five investigations sites in the US.
The study’s findings demonstrated that SMILE resulted in stable vision correction at six months postoperatively. Among the 328 participants (336 eyes) evaluated at six months, all but one had uncorrected (without glasses or contacts) visual acuity (UCVA) of 20/40 or better, and 88 per cent had a UCVA of 20/20 or better. Because there is no LASIK flap involved in SMILE, there is no issue of flap-related complications.

Furthermore, according to surgeon reports, SMILE procedure performed on the VisuMax femtosecond laser system not only led to predictable results and excellent visual outcomes, but also exhibited fast visual recovery with minimal patient discomfort.

Numerous studies and peer reviewed articles have previously been published, demonstrating the immediate and short-term outcomes of SMILE and its advantages and benefits across a wide range of refractive issues. Published work from the group of Zhang et al. (China) to Reinstein et al. (United Kingdom) and Vestergaard et al. (Denmark),3-7 provided evidence on the procedure’s efficacy, safety, predictability, and patient satisfaction.

In Korea, Kim et al.8 conducted a comparative study of the refractive outcomes of SMILE in patients with mild to moderate myopia versus those with high myopia. Based on their findings, the team concluded that SMILE is effective and safe for correcting high myopia and mild to moderate myopia based on UDVA, BCVA, postoperative SE, efficacy index, safety index, and predictability as outcome measures.

In their assessment of the long-term efficacy, predictability, and safety of eyes after SMILE with a three-year follow-up, refractive surgeons from Denmark (Pedersen et al)9 reported that refractive and visual outcomes seem stable. The team also reported that there seems to be a significant long-term improvement in higher-order aberrations after surgery in SMILE.

German investigators (Blum et al.)10 reported the first long term (five-year) results of refractive lenticule extraction (ReLEx) for the treatment of myopia and myopic astigmatism, the results showed that at five years postoperatively, there is no significant change to the six-month data (i.e. spherical equivalent was -0.375 D and therefore was close to target refraction [emmetropia]; and there was no loss of two or more lines over the five-year period). Based on these long-term findings, the team concluded that SMILE is an effective, stable and safe procedure for the treatment of myopia and myopic astigmatism.

“The VisuMax SMILE procedure from ZEISS — a major evolution in refractive surgery — has the potential to revitalize and grow the entire U.S. refractive surgery market,” said Mr. Mazzo.

The FDA approval gives SMILE an indication for use in the reduction or elimination of myopia ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year.

Zeiss is currently conducting an investigational device exemption (IDE) trial in the United States involving astigmatic myopia.

1. ZEISS Press Release. Available at http://www.zeiss.com/meditec/en_de/media-news/press-releases/us-fda-approval-visumax-smile-vision-correction-procedure-in-laser-eye-surgery.html. Accessed on 12 October 2016.
2. FDA Press Release. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm520560.htm. Accessed on 12 October 2016.
3. Zhang J, Wang Y, Wu Wenjing, et al. Vector analysis of low to moderate astigmatism with small incision lenticule extraction (SMILE): results of a 1-year follow-up. Ophthalmology. 2015;15:8.
4. Kunert KS, Russmann C, Blum M, et al. Vector analysis of myopic astigmatism corrected by femtosecond refractive lenticule extraction. J Cataract Refract Surg. 2013; 39:759-769.
5. Kim JR, Hwang HB, Mun SJ, et al. Efficacy, predictability, and safety of small incision lenticule extraction: 6-months prospective cohort study. Ophthalmology. 2014;14:117.
6. Reinstein DZ, Carp GI, Archer TJ, et al. Outcomes of Small Incision Lenticule Extraction (SMILE) in Low Myopia. J Refract Surg. 2014;30(12):812-818.
7. Vestergaard A, Ivarsen AR, Asp S, et al. Small-incision lenticule extraction for moderate to high myopia: Predictability, safety, and patient satisfaction. J Cataract Refract Surg. 2012; 38:2003- 2010.
8. Kim JR, Kim BK, Mun SJ, et al. One-year outcomes of small-incision lenticule extraction (SMILE): mild to moderate myopia vs. high myopia. BMC Ophthalmol. 2015;15:59.
9. Pedersen IB, Ivarsen A, Hjortdal J. Three-Year Results of Small Incision Lenticule Extraction for High Myopia: Refractive Outcomes and Aberrations. J Refract Surg. 2015;31(11):719-724.
10. Blum M, Täubig K, Gruhn C, et al. Five-year results of Small Incision Lenticule Extraction (ReLEx SMILE). Br J Ophthalmol. 2015: 306822.