Article

Anti-inflammatory for cataract surgery reaches phase III endpoints

Preliminary phase III results were released for bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals), meant to treat the inflammation and pain following cataract surgery.

Irvine, CA-Preliminary phase III results were released for bromfenac ophthalmic solution 0.09% (Xibrom, ISTA Pharmaceuticals), meant to treat the inflammation and pain following cataract surgery. The solution achieved statistical significance in the study’s primary endpoint, the absence of ocular inflammation 15 days after cataract surgery, and the secondary endpoint, the elimination of pain 1day post surgery, according to the company.

The confirmatory phase III study was a multicenter, randomized, double-masked, parallel-group study in 299 patients who underwent cataract surgery in one eye. Patients were assigned randomly (1:1) to receive either the bromfenac ophthalmic solution 0.09% once daily or placebo. Dosing began 1 day before cataract surgery and continued for 14 days following surgery.

Ocular inflammation was evaluated using a summed ocular inflammation score (SOIS) and measured by an assessment of immune cells in the anterior chamber of the eye and cellular debris. The secondary efficacy endpoint was evaluated via a pain score from the ocular comfort grading assessment recorded in a diary. At each office visit patients also graded their symptoms, which included photophobia, the chief symptomatic complaint following cataract surgery.

Based on the integrated results of two, phase III studies with the solution, announced in December 2008, the FDA required ISTA to conduct an additional confirmatory study. Once the company completes its analysis of the full dataset, ISTA expects to file a supplemental new drug application seeking approval of the bromfenac 0.09% formulation with the FDA prior to the end of 2009.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) ASCRS 2025: Advancing vitreous care with Inder Paul Singh, MD
(Image credit: Ophthalmology Times) The Residency Report: Study provides new insights into USH2A target end points
Lisa Nijm, MD, says preoperative osmolarity testing can manage patient expectations and improve surgical results at the 2025 ASCRS annual meeting
At the 2025 ASCRS Annual Meeting, Weijie Violet Lin, MD, ABO, shares highlights from a 5-year review of cross-linking complications
Maanasa Indaram, MD, is the medical director of the pediatric ophthalmology and adult strabismus division at University of California San Francisco, and spoke about corneal crosslinking (CXL) at the 2025 ASCRS annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Taylor Strange, DO, assesses early visual outcomes with femto-created arcuate incisions in premium IOL cases
(Image credit: Ophthalmology Times) ASCRS 2025: Neda Shamie, MD, shares her early clinical experience with the Unity VCS system
Patricia Buehler, MD, MPH, founder and CEO of Osheru, talks about the Ziplyft device for noninvasive blepharoplasty at the 2025 American Society of Cataract and Refractive Surgeons (ASCRS) annual meeting
(Image credit: Ophthalmology Times) ASCRS 2025: Bonnie An Henderson, MD, on leveraging artificial intelligence in cataract refractive surgery
(Image credit: Ophthalmology Times) ASCRS 2025: Gregory Moloney, FRANZO, FRCSC, on rotational stability
© 2025 MJH Life Sciences

All rights reserved.