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Steven Schallhorn, M.D. Chief Medical Officer November 12, 2016 ZEISS ReLEx SMILE A Novel Approach to Myopia Vision Correction

A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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Page 1: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

Steven Schallhorn, M.D.

Chief Medical Officer

November 12, 2016

ZEISS ReLEx SMILE A Novel Approach to Myopia Vision Correction

Page 2: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

ZEISS ReLEx SMILE What’s the Big Deal?

Page 3: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

U.S. Laser Vision Correction Market Procedural Volumes Down and Never Recovered

Page 4: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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

Page 5: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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

Page 6: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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:

Page 7: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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

Page 8: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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

Page 9: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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

Page 10: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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

Page 11: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations

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

Page 12: A Novel Approach to Myopia Vision Correction€¦ · by hundreds of centers worldwide with excellent clinical results even in traditionally medically “conservative” locations