Safety and efficacy of bromfenac ophthalmic solution 0.09% (Xibrom™) compared to prednisolone acetate 1% for treatment of ocular inflammation following SLT

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

The mechanism by which selective laser trabeculoplasty (SLT) lowers the intraocular pressure (IOP) may lead to the release of inflammatory mediators in the eye.

Studies have shown increased inflammation and ocular pain after SLT.2-4

Nagar, et al5, showed that after 360 degree SLT, ocular pain was reported in 39% and transient uveitis in 50% of patients.

Topical corticosteroids are commonly used for postoperative pain and inflammation.

However, the adverse events of corticosteroids are well known and include IOP elevation, delayed wound healing, and the promotion of infections.6

William C. Stewart, MDHouston Eye Associates, Houston, TX

PURPOSE

INTRODUCTION

REFERENCES1. Latina MA, et al. Selective targeting of trabecular meshwork cells: in vitro studies of pulse and continuous laser interactions.

Exp Eye Res 1995;60:359-72.2. Kano K, et al. Clinical results of selective laser trabeculoplasty. Nippon Ganka Gakkai Zasshi 1999;103:612-16.3. Martinez-de-la-Casa JM, et al. Selective vs argon laser trabeculoplasty: hypotensive efficacy, anterior chamber inflammation,

and postoperative pain. Eye 2004;18:498-502.4. Damji KF, et al. Selective laser trabeculoplasty versus argon laser trabeculoplasty: results from a 1-year randomised clinical

trial. Br J Ophthalmol 2006;90:1490-94.5. Nagar M, et al. A randomised, prospective study comparing selective laser trabeculoplasty with latanoprost for the control of

intraocular pressure in ocular hypertension and open angle glaucoma. Br J Ophthalmol 2005;89:1413-17.6. Havener WH. Corticosteroid therapy. In: Ocular Pharmacology, 5th ed. St. Louis, MO: CV Mosby:433-500.7. Kitao N, et al. Post-marketing surveillance of bromfenac sodium (Bronuck®) ophthalmic solution – use-result Surveillance.

Atarashii Ganka 2005;22:1299-1308.8. 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

METHODS AND MATERIALS

CONCLUSIONSCONCLUSIONS

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

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 chart below displays the frequency distribution of each cell score at each study visit

Very little cell was noted with either medication

Cells: Very little cell was noted with either medication (Figure 1)

RESULTSFigure 2. Mean IOP at each study visit

Bromfenac was safe and equally efficacious as prednisolone acetate 1% in controlling the signs and symptoms of ocular inflammation and discomfort following SLT.

Figure 1. Frequency distribution of each cell score at each study visit

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.

Duration: 42 days with Selective Laser Trabeculoplasty performed day zero and day 14.

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.

Able to follow study protocol and likely to complete study schedule.

Exclusion Criteria:

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.

Females of childbearing potential.

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).

Intraocular pressure will be evaluated at 28 days post Selective Laser Trabeculoplasty.

Safety measure:

Ocular comfort questionnaire

Visual acuity

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

Although not seen in the present study, these concerns suggest that an alternative to corticosteroids may be appropriate in routine SLT procedures.

Futhermore, the well-established overall safety and tolerability of bromfenac may promote patient compliance with the postoperative treatment regimen.7,8

558834/ P-355

EP = prednisolone acetate 1%

RESULTS

Flare: 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

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

Burning: 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%)

Grittiness: 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

1 patient reported mild grittiness at Day 1 (1/45, 2.2%) with prednisolone acetate Photophobia: 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

IOP: Mean IOP was consistent throughout the two treatment regimens (Figure 2)