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Steven Schallhorn, M.D.
Chief Medical Officer
November 12, 2016
ZEISS ReLEx SMILE A Novel Approach to Myopia Vision Correction
ZEISS ReLEx SMILE What’s the Big Deal?
U.S. Laser Vision Correction Market Procedural Volumes Down and Never Recovered
ZEISS ReLEx SMILE Now FDA Approved
• Corrects myopia from -1.00 to -8.00D with ≤ 0.50 D of cylinder (Up to -10.00D
with flag warning)
• Small ”contact lens” shaped piece of tissue (lenticule) precisely removed
• Cornea shape permanently changed
• A ‘small incision’ solution
ZEISS ReLEx SMILE will (hopefully!) grow LVC market
• First major innovation in U.S. LVC market in 16 years (since Femto-LASIK in 2000)
• New LVC option for refractive surgeons to offer patients fearful of LASIK
• SMILE developed in Europe with 600,000+ procedures OUS; proven technology
U.S. Laser Vision Correction Market Impact of ZEISS ReLEx SMILE
Risk of Contact Lenses
• One in Six Adults in USA wears CLs
• Over 40 Million CL wearers in USA alone
• One in three have health care visit related
to contact problems
• 99% reported at least one risky behavior
for infection/inflammation
• Most wear spherical contacts lenses
• Infiltrates, infections, ulcers, GPC,
abrasions
• Many find risk profile of LASIK/PRK
unacceptable
CDC Study (2014) Found:
Problems with Contact Lenses
54.7%
16.1%
10.1%
3.8% 3.6% 3.5% 1.8% 1.7% 1.4% 1.3% 1.2% 0.7%
0%
10%
20%
30%
40%
50%
60%
45% of patients report some problem with their Contact Lenses
6,196 patients
Patients “Get It”
• Lose the inconvenience and problems of
contact lenses
• Deem it medically and socially acceptable
• Like the concept of a small incision
procedure (minimally invasive)
• Like that it is quick, quiet, painless and
performed with one laser
My Take as CMO about the FDA Study
• Patients did very well
• No unexpected outcomes or refractive surprises
• Accurate at all levels of myopia
• Visual recovery was fast and painless
• NO DLK or significant complications
• It does require more surgeon skill
Most patients preferred their SMILE eye to their LASIK eye
Integration Into a Practice
• Another Option to LASIK/PRK/ICL
• Best suited for spherical or low cylinder patients
• Positioned as premium procedure
• Especially good choice for police/fire fighters/active sports
Some patients may want to wait for sphero/cylinder option which will (hopefully) be
available next year
Worldwide Acceptance of ReLEx SMILE
Hundreds of thousands of vision correction procedures already performed
by hundreds of centers worldwide with excellent clinical results even in
traditionally medically “conservative” locations
More than
600 clinics
worldwide
More than
1,000 practicing
surgeons
More than
62 countries
More than
600,000 ReLEx SMILE
procedures