1. Ketorolac vs. Bromfenac: A Review of Seven Prospective Randomized Studies Comparing PGE2 Inhibition & 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
Penetration • PGE2 • Peak Dosing • On Label
(Acular LS 0.4%)
p > .001
Ketorolac ng/ml
Bromfenac (Xibrom 0.09%) ng/ml
n = 30
(QID x 3 days preop)
q 10 min x min pre op
n = 32
(BID x 3 days preop)
Acular LS ~20X vs. Xibrom
q 10 min x min 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= n=32
Bucci – ARVO 2007
n= n=28

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

4. Acular LS vs. Xibrom Acular LS PGE2 • QID x 2 days pre op
“Trough dosing day run up’’ (on label)
Acular LS
• QID x 2 days pre op
• sample 6 hrs after
last dose DOS
Xibrom
• BID x 2 days pre op
• sample 12 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

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. ACUVAIL vs. Xibrom vs. Nevanac
Methods Peak Dosing
• randomized • eyes
• on label • double-masked
3 Groups Peak dosing (on label)
drug
concentration
ACUVAIL BID
1 day pre op
1 gtt. am DOS
4 gtts. q15 min
1 hr prior to sx.
Xibrom BID
1 gtt. am DOS
4 gtts. q15 min
Nevanac TID
Aqueous
Sample
PGE 2 levels
• aqueous penetration
• prostaglandin inhibition (PGE2)

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

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

9. ACUVAIL vs. Xibrom vs. Nevanac
PGE2
320.4
288.7
224.8
pg/ml *
p=0.025
(vs Nev) *
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 • eyes • on label
Trough Single dose model
• no days pre op dosing
• no immediate pre op dosing
ACUVAIL (q 12 hr) one dose
12 hrs prior 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
Xibrom > Nevanac
ACUVAIL >t Xibrom
3. Trough PGE2
ACUVAIL (q12) > Xibrom (q 24) * * * *