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Frank A. Bucci, Jr., MD Bucci Laser Vision Institute Wilkes Barre, Pa

Ketorolac vs. Bromfenac: A Review of Seven Prospective Randomized Studies Comparing PGE 2 Inhibition & Aqueous Penetration. Frank A. Bucci, Jr., MD Bucci Laser Vision Institute Wilkes Barre, Pa

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Frank A. Bucci, Jr., MD Bucci Laser Vision Institute Wilkes Barre, Pa

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  1. Ketorolac vs. Bromfenac:A Review of Seven ProspectiveRandomized Studies Comparing PGE2Inhibition & Aqueous Penetration Frank A. Bucci, Jr., MD Bucci Laser Vision Institute Wilkes Barre, Pa The author of this poster has received a research grant from Allergan, Inc.

  2. Penetration • PGE2 • Peak Dosing • On Label Acular LS vs.Xibrom (Acular LS 0.4%) p > .001 n = 30 (QID x 3 days preop) q 10min x 4 90min pre op • Ketorolac 772.5 ng/ml • Bromfenac (Xibrom0.09%)39.5 ng/ml n = 32 (BID x 3 days preop) Acular LS ~20X vs. Xibrom q 10min x 4 90min pre op Penetration • Peak dosing mean PGE2 • Peak dosing 277.3 250.8 772.5 p>.001 pg/ml ng/ml 39.5 Xibrom Acular LS Xibrom n=30 n=32 n=28n=28 Bucci – ARVO 2007

  3. “Trough - Single dose” • Penetration • PGE 2 mean Penetration Acular LS vs.Xibrom (Acular LS 0.4%) 130.5ng/ml (21.1X) 6 hrspost single dose p = .004 n= 28 Bromfenac (Xibrom 0.09%) • Ketorolac 6.2 ng/ml 12 hrspost single dose Acular LS ~ 20Xvs. Xibrom n = 28 PGE2 Penetration 263.7 130.5 204.2 * * p = .004 * *p = .020 ng/ml pg/ml Acular LS Xibrom Acular LS n = 28 n = 28 Xibrom n = 28 n = 28 J Cat Refract Surg - 2008

  4. “Trough dosing-2day run up’’ (on label) Acular LS vs. Xibrom Xibrom •BID x 2 days pre op • sample 12 hrs after last dose DOS • Acular LS • • QIDx 2 days pre op • • sample6 hrs after • last dose DOS Penetration PGE2 386.24 83.6 pg/ml 285.6 ng/ml 9.1 X (p < .001) * * p=.006 9.2 Acular LS QID Xibrom BID Acular LS QID Xibrom BID n = 30 n = 31 n = 30 n = 31 Advance Therapy - 2009

  5. ACUVAIL • Distinguishing Characteristics • 1. Reduction in pH to 6.8 • • more un-ionized drop available • for absorption • 2. Increased drug concentration to 0.45% • • vs. 0.4%Acular LS • 3. Addition of CMC • • improves comfort • • protects ocular surface • • prolongs drug retention • 4. No BAK, EDTA or Octoxynal

  6. ACUVAILvs.Xibromvs.Nevanac Methods Peak Dosing • • randomized • 122 eyes • • on label • double-masked • 3Groups Peak dosing (on label) drug concentration Aqueous Sample PGE 2 levels • aqueous penetration • prostaglandin inhibition (PGE2)

  7. ACUVAILvs. Xibrom vs. Nevanac Aqueous Penetration • Peak dosing (on label ) 688.8 54% 447.1 5X 10X 140.3 67.6

  8. ACUVAIL vs. Xibromvs.Nevanac PGE 2 Inhibition • Peak dosing (on label) • ACUVAIL224.8 ± 164.9 pg/ml • (n = 42) • Xibrom 288.7 ± 226.1 pg/ml t • (n = 41) • Nevanac 320.4 ± 205.6 pg/ml * • (n = 38) t p < 0.10 * p < 0.05

  9. PGE2 ACUVAILvs.Xibrom vs.Nevanac 320.4 288.7 224.8 pg/ml * p=0.025 (vsNev) * ACUVAIL Xibrom Nevanac (n=42) (n=41) (n=38) PGE 2 Inhibition • Peak dosing (on label) ACUVAIL vs. Nevanac (p = 0.025) * Xibrom vs. Nevanac (p = 0.516) ACUVAIL vs. Xibrom (p = 0.10) t

  10. ACUVAIL vs. Xibrom • Trough Dosing • • randomized • single dose • double-masked• 120 eyes• on label Trough - Single dose model • no days pre op dosing • no immediate pre op dosing ACUVAIL (q 12 hr) one dose 12 hrsprior to sample Xibrom(q 24 hr) one dose 24 hrs prior to sample

  11. ACUVAIL vs.Xibrom Trough • Single Dose • PGE2 pg/ml n = 53 n = 53

  12. ACUVAIL • Conclusions * • 1. Peak Penetration • ACUVAIL > Xibrom • ACUVAIL > Nevanac • 2. Peak PGE2 • ACUVAIL > Nevanac • Xibrom > Nevanac • ACUVAIL >tXibrom • 3. Trough PGE2 • ACUVAIL (q12) > Xibrom (q 24) * * *

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