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 al 5, 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, MD Houston Eye Associates, Houston, TX PURPOSE INTRODUCTION REFERENCES 1.Latina MA, et al. Selective targeting of trabecular meshwork cells: in vitro studies of pulse and continuous laser interactions. Exp Eye Res 1995;60: Kano K, et al. Clinical results of selective laser trabeculoplasty. Nippon Ganka Gakkai Zasshi 1999;103: Martinez-de-la-Casa JM, et al. Selective vs argon laser trabeculoplasty: hypotensive efficacy, anterior chamber inflammation, and postoperative pain. Eye 2004;18: Damji KF, et al. Selective laser trabeculoplasty versus argon laser trabeculoplasty: results from a 1-year randomised clinical trial. Br J Ophthalmol 2006;90: 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: Havener WH. Corticosteroid therapy. In: Ocular Pharmacology, 5 th ed. St. Louis, MO: CV Mosby: Kitao N, et al. Post-marketing surveillance of bromfenac sodium (Bronuck®) ophthalmic solution – use-result Surveillance. Atarashii Ganka 2005;22: Donnenfeld ED, et al. Bromfenac ophthalmic solution 0.09% (Xibrom) for postoperative ocular pain and inflammation. Ophthalmol 2007;114(9): 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 CONCLUSIONS  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) RESULTS Figure 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, / 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 (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)