Use of Nepafenac in Lasek Johnny L. Gayton, MD

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1 Use of Nepafenac in Lasek Johnny L. Gayton, MD Kathrine Jackson, COA Eyesight Associates, Warner Robins, GA

2 Analgesic Effect NSAIDs provide analgesic effect 1-3 Minimize pain and discomfort following cataract and refractive surgery Minimize pain with abrasions and keratitis Standard of care following surface laser ablation procedures 4 1. Yee RW, Ketorolac Radial Keratotomy Study Group. Analgesic efficacy and safety of nonpreserved ketorolac ophthalmic solution following radial keratotomy. Am J Ophthalmol 1998;125: Eiferman RA, Hoffman RS, et al. Topical diclofenac reduced pain following photorefractive keratectomy. Arch Ophthalmol 1993;111: Szerenyi K, Sorken K, et al. Decrease in normal human corneal sensitivity with topical diclofenac sodium. Am J Ophthalmol 1994;118: Kaiser PK, Pineda R II. A study of topical nonsteroidal antiinflammatory drops and no pressure patching in the treatment of corneal abrasions. Ophthalmology 1997;104:

3 Conventional NSAID Therapies Slowly penetrate intraocular tissues 1 Slower penetration coefficient may lead to: Decreased intraocular efficacy 2 Increased risk of surface complications 2 2. O Brien TP. Emerging Guidelines for Use of NSAID Therapy to Optimized Cataract Surgery 1. Ke, TL, et al, Inflammation. 2000;24(4): Patient Care. Curr Med Res & Opin. 2005; Vol. 21, No. 7,

4 Adverse Events Commonly Associated with Conventional NSAID Therapy NSAIDs frequently associated with unwelcome corneal effects 1 : Burning and irritation Superficial punctate keratitis Delayed wound healing Severe corneal issues also reported with conventional NSAIDs 2 Thinning Perforation due to melts 1. Flach, AJ. Topical nonsteroidal antiinflammatory drugs in ophthalmology. Int Ophthalmol Clin. 2002;42(1): Mah et al. ASCRS Prescribing Information: VOLTAREN; ACULAR; ACULAR LS.

5 Introduction of Generic Diclofenac to Middle GA Area Very aggressive melts Two required pericardial grafts One required suturing One required corneal transplantation

6 Photo by Val Sanders, CRA, COT

7 Photo by Val Sanders, CRA, COT

8 Photo by Val Sanders, CRA, COT

9 Photo by Val Sanders, CRA, COT

10 Novel Pro-Drug Structure Optimizes Penetration Upon ocular dosing, nepafenac rapidly penetrates the intraocular tissues 1 Target-Specific Efficacy Nepafenac is converted into amfenac for optimal efficacy 2 : Amfenac Amfenac Amfenac Nepafenac Cornea Iris/CB Retina/Choroid Nepafenac Amfenac 2. Ke, TL, et al, Inflammation. 2000;24(4): Gamache, DA, et al, Inflammation. 2000;24(4):

11 Analgesic Efficacy: Mode of Action Nepafenac s s enhanced permeability allows it to rapidly penetrate the cornea Nepafenac to Amfenac (potent NSAID) bioactivation is initiated in the cornea Nepafenac possesses inherent analgesic properties Nepafenac Amfenac Ke, TL, et al, Inflammation. 2000;24(4):

12 Evaluation of Analgesic Effect Following PRK Purpose Evaluation of safety/efficacy of nepafenac 0.1% Ophthalmic Suspension vs. diclofenac 0.1% Methods 60 patient, multi-center, randomized, double- masked, parallel groups Dosing: 2 drops preoperatively, 1 drop one hour after surgery, QID postoperatively Submitted for Publication. Sept. 2005

13 Results Pain Scores following PRK Severe 9 8 Pain Scores * * None 0 Day 1 - am Day 1 - noon Day 1 - pm Day 1 - Bedtime Day 2- am Day 2 - noon Day 2 - pm Day 2 - Bedtime Nepafenac 0.1% Diclofenac 0.1% *p = Submitted for Publication. Sept. 2005

14 PRK Epithelial Healing Results Percentage of Patients with Complete reepithelization Nepafenac 0.1% Diclofenac 0.1% 10 0 Day 3 Day 7 Colin J, Paquette B. Comparison of the Analgesic Efficacy of Nepafenac Ophthalmic Suspension Compared to Diclofenac Ophthalmic Solution for Ocular Pain and Photophobia After Excimer Laser Surgery. Accepted for publication. 2006

15 Evaluation of Analgesic Effect Following PRK Conclusions Nepafenac 0.1% found to provide equal or greater analgesic effect at all time points as compared to Diclofenac 0.1% in patients undergoing PRK Nepafenac 0.1% was safe and well tolerated in patients undergoing PRK Submitted for Publication. Sept. 2005

16 Eyesight Associates chatter caused us to think patients receiving Nevanac may have delayed re- epithelialization and increased discomfort. Also revealed problems with Technique of Nevanac usage. (e.g. soaking contacts, plugs, lack of tears, bare stroma, duration) Performed a small blind study coordinated by K. Jackson comparing Nevanac and Acular LS

17 Use of Nevanac and Acular LS in LASEK - Small Pilot Study 15 patients undergoing LASEK in both eyes 8 male, 7 female Age range of 23 to 79 years old Myopia range: to diopters Astigmatism: -.50 to diopters

18 Pilot Study Guidelines Blind study NSAID used tid both eyes, starting 1 day preoperative, then continued tid for up to 5 days Nevanac was used in one eye, the other eye was treated with Acular LS All Patients had post op visits at: 1 day 4 days As needed 2 weeks

19 Pilot Study Results 1 day post op: No eyes were re-epithelialized No infiltrates were present upon slit lamp examination Difference in pain level reported by patients using a 1-10 scale Nevanac - 0 to 6 with average 2.0 Acular LS - 0 to 6 with average 2.9

20 Pilot Study Results 4 days post op: 23 of 30 eyes were fully re-epithelialized 7 eyes were not fully re-epithelialized All of these eyes were from people with moderate to severe dry eyes pre-op. These eyes all re-epithelialized within the 10 day post op period. 4 were Acular LS and 3 Nevanac Pain level was evaluated using a 1-10 scale Nevanac - 1 to 9 with average of 2.6 Acular LS - 1 to 8 with average of 2.6

21 Nevanac was more comfortable than Acular LS Nine patients complained of Acular LS burning upon instillation One patient also complained of Nevenac burning

22 Preliminary Conclusions of Pilot Study Nevanac was more comfortable than Acular LS Nevanac was determined to be equal to Acular LS in Re-epithelialization Pain Control Visual recovery (Since there was no difference in the two groups) Nine patients complained of Acular LS burning upon instillation One patient also complained of Nevenac burning

23 Additional Data Over 200 additional eyes undergoing surface ablation at EA received Nevanac No significant haze noted No difference in re-epithelialization rate noted No subjective difference in pain level reported Same rate of visual acuity recovery

24 Post LASEK with Nevanac Therapy 4 DAYS POST TREATMENT Photos by Val Sanders, CRA, COT

25 Post LASEK with Nevanac Therapy 4 DAYS POST TREATMENT Photos by Val Sanders, CRA, COT

26 Post LASEK with Nevanac Therapy 4 DAYS POST TREATMENT Photos by Val Sanders, CRA, COT

27 Evaluation of Analgesic Effect Following PRK (Donnenfeld,, et al., 2006) Purpose Evaluation of safety/efficacy of NEVANAC ophthalmic suspension vs. ACULAR LS Methods 80 eyes, multi-center, randomized, double- masked, parallel groups Dosing: TID x 3 days Donnenfeld ED, Durrie DS, Holland EJ, Raizman MB. A Double-Masked Study of Nepafenac 0.1% and Ketorolac 0.4% for Pain and Epithelial Healing Following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV.

28 Results Average Pain Scores Following PRK (Donnenfeld,, et al., 2006) Pain Score n = 80 eyes P= Day 1 Day 3 Day 4 NEVANAC ACULAR LS NEVANAC demonstrated a statistically significant advantage in pain control at day 3 Donnenfeld ED, Durrie DS, Holland EJ, Raizman MB. A Double-Masked Study of Nepafenac 0.1% and Ketorolac 0.4% for Pain and Epithelial Healing Following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV.

29 Mean Epithelial Defect Size Following PRK (Donnenfeld,, et al., 2006) Epithelial Defect Size (mm 2 ) n = 80 eyes Defects Healed Surgery Day 3 Day 4 Day 5 Day 7 Day 10 ACULAR LS NEVANAC Donnenfeld ED, Durrie DS, Holland EJ, Raizman MB. A Double-Masked Study of Nepafenac 0.1% and Ketorolac 0.4% for Pain and Epithelial Healing Following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV.

30 NEVANAC vs. Placebo in Pain Relief and Epithelial Healing Following PRK Purpose To determine the subjective pain and wound healing after PRK in eyes using either Nevanac or BSS Methods 132 eyes, single-center, placebo controlled prospective double masked randomized study Dosing: TID x 2 days Reilly C, Caldwell M. Double-Masked Study of Nepafenac 0.1% and Placebo on Pain Relief and Epithelial Healing Following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV.

31 Results Average Pain Scores following PRK P = P < n = 132 eyes pain free POD#1 POD#2 POD#3 POD#4 Nevanac Placebo NEVANAC demonstrated a significant advantage in pain control for post op day 1 and 2 Reilly C, Caldwell M. Double-Masked Study of Nepafenac 0.1% and Placebo on Pain Relief and Epithelial Healing Following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV.

32 Epithelial Defect Healing: NEVANAC vs. BSS Epithelial Defect Size (mm 2 ) defectsh ealed Surgery POD#1 POD#2 POD#3 POD#4 NEVANAC Placebo Reilly C, Caldwell M. Double-Masked Study of Nepafenac 0.1% and Placebo on Pain Relief and Epithelial Healing Following PRK.. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV.

33 Evaluation of Wound Healing Following PRK in Humans NEVANAC vs. ACULAR LS 1 (n=80 eyes), Donnenfeld, Raizman,, et al., USA Dosing: TID x 3 days No difference in epithelial healing times at all time points Advantage in pain control and comfort for NEVANAC All eyes healed NEVANAC vs. BSS 2 (n=132 eyes), U.S.A.F., Wilford Hall Medical Center Dosing: TID x 2 days No difference in epithelial healing times at all time points Advantage in pain control for NEVANAC All eyes healed Nepafenac 0.1% vs. Diclofenac 0.1% 3 (n=60), Colin, et al., France Dosing: QID x 2 days NEVANAC eye healing faster at Day 3 All eyes healed by Day 7 1. Donnenfeld ED, Durrie DS, Holland EJ, Raizman MB. A double-masked study of nepafenac 0.1% and ketorolac 0.4% for pain and epithelial healing following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV. 2. Reilly C, Caldwell M. Double-masked study of nepafenac 0.1% and placebo on pain relief and epithelial healing following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV. 3. Colin J, Paquette B. Comparison of the analgesic efficacy and safety of nepafenac ophthalmic suspension compared with diclofenac ophthalmic solution for ocular pain and photophobia after excimer laser surgery: a phase II, randomized, double-masked trial. Clinical Therapeutics 2006;28(4):527-36

34 Safety in Refractive Use Investigator 1) Colin et al. Surgery PRK Dosing QID x 2d Number of Eyes 60 Delayed Healing 0 2) Reilly et al. PRK TID x 2d ) Donnenfeld et al. PRK TID x 3d Totals Colin J, Paquette B. Comparison of the analgesic efficacy and safety of nepafenac ophthalmic suspension compared with diclofenac ophthalmic solution for ocular pain and photophobia after excimer laser surgery: a phase II, randomized, double-masked trial. Clinical Therapeutics 2006;28(4): Reilly C, Caldwell M. double-masked study of nepafenac 0.1% and placebo on pain relief and epithelial healing following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV. 3. Donnenfeld ED, Durrie DS, Holland EJ, Raizman MB. A double-masked study of nepafenac 0.1% and ketorolac 0.4% for Pain and Epithelial Healing Following PRK. Accepted for presentation to the American Academy of Ophthalmology, November 11-14, 2006, Las Vegas, NV.

35 Summary NEVANAC stands as the only ophthalmic prodrug NSAID and demonstrates excellent efficacy and safety Unique prodrug structure allows for unique target specific activity Optimizes penetration through cornea to ICB, and retina/choroid Delivers excellent inflammation suppression Comfortably and Safely provides excellent analgesia following Lasek and PRK

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