Transcript Slide 1

Safety and efficacy of bromfenac ophthalmic solution 0.09% (Xibrom™) compared to
prednisolone acetate 1% for treatment of ocular inflammation following SLT
William C. Stewart, MD
558834/ P-355
Houston Eye Associates, Houston, TX
INTRODUCTION
 Recently a new approach to laser trabeculoplasty has been introduced with the
development of selective laser trabeculoplasty (SLT), in which a Q-switched, frequency
doubled, Nd:YAG laser emitting at 532 nm is used to selectively target pigmented
trabecular cells without causing thermal damage to adjacent non-pigmented meshwork
structures.1
RESULTS
Figure 2. Mean IOP at each study visit
Patient Demographics:
 Mean patient age was 64.3 yrs ± 13.2 (range: 32-84)
 Gender was evenly distributed: 26/50 patients were male (52%)
 24/50 patients were female (48%)
 The mechanism by which selective laser trabeculoplasty (SLT) lowers the intraocular
pressure (IOP) may lead to the release of inflammatory mediators in the eye.
 The chart below displays the frequency distribution of each cell score at each study visit
 Studies have shown increased inflammation and ocular pain after SLT.2-4
Cells:
 Nagar, et
showed that after 360 degree SLT, ocular pain was reported in 39% and
transient uveitis in 50% of patients.
al5,
 Topical corticosteroids are commonly used for postoperative pain and inflammation.
RESULTS
 Very little cell was noted with either medication
 Very little cell was noted with either medication (Figure 1)
Figure 1. Frequency distribution of each cell score at each study visit
 However, the adverse events of corticosteroids are well known and include IOP
elevation, delayed wound healing, and the promotion of infections.6
PURPOSE
 To evaluate the safety and efficacy of bromfenac 0.09% compared to prednisolone
acetate 1% for the treatment of ocular inflammation following selective laser
trabeculoplasty (SLT).
DISCUSSION
 In this study bromfenac was effective in controlling the ocular pain and inflammation associated
with SLT.
 Bromfenac demonstrated ocular anti-inflammatory and analgesic properties comparable to
prednisolone acetate.
 Adverse events of corticosteroids are well known and include IOP elevation, delayed wound
healing, and the promotion of infections.6
METHODS AND MATERIALS

This was an open-label, single-center, contralateral eye study of 50 consecutive adult patients
with open angle glaucoma (OAG) or ocular hypertension who required SLT.

All patients used bromfenac BID for 7 days in the affected eye following SLT.

Prednisolone acetate QID was applied to the contralateral eye for 7 days following SLT.

Outcome measures included ocular inflammation, IOP, and ocular comfort questionnaire
measured at baseline, Day 7, and Day 14, following SLT.
EP = prednisolone acetate 1%

Duration: 42 days with Selective Laser Trabeculoplasty performed day zero and day 14.
Flare:
PATIENTS:

50 patients with 100 eyes evaluated.
Inclusion Criteria:

Adult patients at least 18 years old of either gender or any race with open-angle glaucoma or
ocular hypertension who require laser trabeculoplasty.

Written and informed consent and authorization will be obtained prior to any study related
procedures.
 With prednisolone acetate , flare was noted only on Day 14 +1 (one day after SLT on the second
eye)
6 eyes (6/45, 13.3%) were graded as 1
No flare was noted at any other time point
Any history of neovascular or ocular inflammatory disease.

Patients with known sensitivity to non-steroidal anti-inflammatories.

Current use of topical or systemic anti-inflammatory medications.
Grittiness:

Females of childbearing potential.
 Very few patients reported grittiness with either treatment
1 patient reported mild grittiness at Day 1 (1/49, 2.0%) and 1 at Day 7 (1/49, 2.0%) with
bromfenac
Exclusion Criteria:
Criteria for Evaluation:
Efficacy measure:

Slit lamp Biomicroscopy: Slit lamp grading of ocular inflammation will be performed and graded
according to the standard Ocular Inflammation Scale (OIS).
CONCLUSIONS
 Bromfenac was safe and equally efficacious as prednisolone acetate 1% in controlling the signs
and symptoms of ocular inflammation and discomfort following SLT.
Burning:

Able to follow study protocol and likely to complete study schedule.
 Futhermore, the well-established overall safety and tolerability of bromfenac may promote
patient compliance with the postoperative treatment regimen.7,8
 With bromfenac, flare was noted only on Day 1
12 eyes (12/49, 24.5%) were graded as 1 (very slight)
1 eye (1/49, 20.4%) was graded as 2 (mild)
No flare was noted at any other time point
 Very few patients reported burning with either treatment
2 patients (2/49, 4.1%) reported mild burning at Day 1 with bromfenac and 1 reported moderate
burning at Day 14
2 patients reported mild burning at Day 1 with prednisolone acetate (2/45, 4.4%) and 1 reported
mild burning at day 7 (2/42, 4.8%)

 Although not seen in the present study, these concerns suggest that an alternative to
corticosteroids may be appropriate in routine SLT procedures.
1 patient reported mild grittiness at Day 1 (1/45, 2.2%) with prednisolone acetate
REFERENCES
1.
2.
3.
4.
5.
Photophobia:
6.
7.
8.
Safety measure:
 Throughout the study, only 1 patient reported any degree of photophobia
1 patient (1/42, 2.4%) after 7 days of prednisolone acetate reported mild photophobia

Ocular comfort questionnaire
IOP:

Visual acuity

Intraocular pressure will be evaluated at 28 days post Selective Laser Trabeculoplasty.
 Mean IOP was consistent throughout the two treatment regimens (Figure 2)
Latina MA, et al. Selective targeting of trabecular meshwork cells: in vitro studies of pulse and continuous laser interactions.
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Kano K, et al. Clinical results of selective laser trabeculoplasty. Nippon Ganka Gakkai Zasshi 1999;103:612-16.
Martinez-de-la-Casa JM, et al. Selective vs argon laser trabeculoplasty: hypotensive efficacy, anterior chamber inflammation,
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Nagar M, et al. A randomised, prospective study comparing selective laser trabeculoplasty with latanoprost for the control of
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Havener WH. Corticosteroid therapy. In: Ocular Pharmacology, 5th ed. St. Louis, MO: CV Mosby:433-500.
Kitao N, et al. Post-marketing surveillance of bromfenac sodium (Bronuck®) ophthalmic solution – use-result Surveillance.
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Donnenfeld ED, et al. Bromfenac ophthalmic solution 0.09% (Xibrom) for postoperative ocular pain and inflammation.
Ophthalmol 2007;114(9):1653-1662.
Presented at the American Society of Cataract an Refractive Surgery
(ASCRS) Annual Symposium & Congress, April 4- April 8, 2009,
San Francisco, CA