1. Topical Cyclosporine for Postoperative use in PRK and LASIK: Preliminary Results LCDR David D. Hessert, M.D. Ophthalmology Chief Resident Naval Medical Center San Diego The authors have no financial interest in the products or procedures discussed

2. Navy Refractive Surgery Center San Diego Research Team CAPT David J. Tanzer MD LCDR Tyson Brunstetter OD, PhD CDR Elizabeth Hofmeister MD CDR Frank Bishop MD CDR David Beverly MD Donna Murdoch PhD Sandy Kaupp MS Neil Kelly PhD Jim Newacheck OD Steve Toman OD Myah Mirzaoff BS The views expressed in this presentation are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the United States Government.

3. Research Objectives Determine whether topical cyclosporine A improves final visual performance following PRK & LASIK Evaluate differences in the rate of improvement in uncorrected visual acuity for patients receiving topical cyclosporine or standard topical treatment before and after PRK and LASIK F/A-18C taking off from USS Nimitz

4. Topical Cyclosporine for Postoperative Use in PRK & LASIK: Study Design 100 LASIK 50 Standard Treatment 11 in Follow up 50 Standard Treatment + Cyclosporine A 3 months Postop 11 in Follow up 100 PRK 50 Standard Treatment 18 in Follow up 50 Standard Treatment + Cyclosporine A 3 months Postop 19 in Follow up All numbers refer to subjects, both eyes of each subject are analyzed

5. Topical Cyclosporine for Postoperative Use in PRK & LASIK: Preliminary Analysis PRK with cyclosporine PRK with standard treatment LASIK with cyclosporine LASIK with standard treatment GenderMale = 16 Female = 3 Male = 16 Female = 2 Male = 8 Female = 3 Male = 9 Female = 2 Agemean = 27.5 SD = 4.6 range = 22-37 mean = 25.0 SD = 2.8 range = 22-32 mean = 27.8 SD = 5.0 range = 23-39 mean = 30.6 SD = 5.3 range = 25-42 Treatment (WaveScan MRSE) mean = -2.79 SD = 1.15 range = -0.75 to -5.71 mean = -2.36 SD = 1.27 range = -1.01 to -5.56 mean = -2.77 SD = 1.28 range = -1.15 to -6.39 mean = -2.27 SD = 1.13 range = -0.51 to -3.84

6. Preliminary Results: Postop UCVA No significant difference in any group or interval

7. Preliminary Results: Postoperative Pain No significant difference in LASIK More immediate post op pain for PRK subjects getting topical Cyclosporine

8. Preliminary Results: Postoperative Tearing No significant difference

9. Preliminary Results: Photophobia No difference in LASIK More immediate post op photophobia for PRK subjects getting topical Cyclosporine

10. Preliminary Results: Change in Low Contrast Acuity at 1 Month Postop No significant difference

11. Conclusions Preliminary data does not demonstrate a benefit to topical Cyclosporine postoperatively for patients undergoing PRK or LASIK Topical Cyclosporine is associated with increased postoperative pain and photophobia when used following PRK

12. References Safety and Efficacy of Cyclosporine 0.05% Drops Versus Unpreserved Artificial Tears in Dry-Eye Patients Having Laser In Situ Keratomileusis. Salib GM et al. J Cataract Refract Surg. 2006; 32:772-8. Effect of Cyclosporine A on Recovery of Visual Acuity Following LASIK. Ursea R et al. J refract Surg. 2007 The Effect of Tear Film and Ocular Surface Management on Myopic LASIK Outcomes. Albietz J et al. Adv Exp Med Biol. 2002; 506(pt A):711-7. Decrease in Tear Secretion and Corneal Sensitivity After Laser In Situ Keratomileusis. Benitez-del-Castillo JM et al. Cornea. 2001; 20(1):30-2. Two Multicenter, Randomized Studies of the Efficacy and Safety of Cyclosporine Ophthalmic Emulsion in Moderate to Severe Dry Eye Disease. Sall K et al. Ophthalmology. 2000; 107(4):631-9.