IRVINE, CA--(Marketwire -05/10/12)- ISTA Pharmaceuticals, Inc. (ISTA), today presented results from the second of two Phase 3 studies of PROLENSA™ (bromfenac ophthalmic solution), the Company's once-daily topical nonsteroidal anti-inflammatory product candidate for the treatment of ocular inflammation and pain following cataract surgery. The findings showed PROLENSA met both the study's primary and secondary efficacy endpoints, producing statistically greater clearing of subjects' ocular inflammation by Day 15 and a greater proportion of subjects that were pain free at one day post-cataract surgery than placebo. These data were presented in a poster session at the 2012 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held from May 6-10, 2012, in Fort Lauderdale, FL. Last month, ISTA presented similar results from the Company's first Phase 3 study in a poster session at the 2012 American Society of Cataract and Refractive Surgery (ASCRS) Symposium and Congress in Chicago, IL. Data from both studies were collected under a common protocol and conducted and analyzed as two independent studies in the U.S. Based on the results of the two Phase 3 studies, ISTA intends to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for PROLENSA in the first half of 2012.
Additional data from the poster presentation, titled "Efficacy of Low-Concentration, Modified Bromfenac Ophthalmic Solution Administered Once Daily for Ocular Inflammation and Pain Associated with Cataract Surgery", demonstrated that there were no serious drug-related ocular or systemic adverse events, and that PROLENSA's safety profile was consistent with ISTA's currently marketed once-daily topical nonsteroidal anti-inflammatory (NSAID) compound, BROMDAY™ (bromfenac ophthalmic solution) 0.09%.
Authors of the poster were Sharon K. Klier, MD, MPH, James H. Peace, MD, Damien F. Goldberg, MD, James A. Gow, MD, Timothy R. McNamara, PharmD for the Low Concentration Bromfenac Ophthalmic Solution Once Daily Study Group.
ABOUT THE PHASE 3 PROGRAM
ISTA conducted two Phase 3 multi-center, randomized, double-masked, parallel-group controlled studies. Each study enrolled two hundred and twenty (220) subjects who underwent cataract surgery in one eye (unilateral). Subjects were assigned randomly (1) to receive either PROLENSA once daily or placebo (vehicle) once daily. Dosing of PROLENSA began one day before cataract surgery and continued on the day of surgery and for 14 days following cataract surgery. The proportion of subjects experiencing no ocular pain was assessed at Day 1 post surgery and throughout the study, and the proportion of subjects with complete absence of ocular inflammation was assessed as early as Day 1 post surgery through Day 22 post surgery. Ocular inflammation was evaluated using a summed ocular inflammation score (SOIS) and was measured by an assessment of cells in the anterior chamber of the eye ("cells") and cellular protein ("flare"). The secondary efficacy endpoint was evaluated via a pain score from the Ocular Comfort Grading Assessment (OCGA) recorded in a patient's diary. Safety was assessed based on several variables, including adverse events, ophthalmic evaluations, and OCGA.
PROLENSA™ (bromfenac ophthalmic solution) is being developed as a once-daily topical nonsteroidal anti-inflammatory compound for the treatment of ocular inflammation and pain following cataract surgery. PROLENSA incorporates a lower concentration of bromfenac than the company's current once-daily NSAID, BROMDAY (bromfenac ophthalmic solution) 0.09% in a new, modified ophthalmic formulation. From 2005 until 2011, ISTA marketed XIBROM (bromfenac ophthalmic solution)® 0.09% in the U.S. for twice-daily use for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. In October of 2010, ISTA received FDA approval for once-daily BROMDAY and discontinued shipments of XIBROM in February 2011. BROMDAY is currently the only once-daily treatment option in the $370 million U.S. ophthalmic nonsteroidal anti-inflammatory market. ISTA acquired the U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. A U.S. patent was issued to ISTA's licensor, Senju, for PROLENSA, which expires in September 2025. PROLENSA is an investigational drug and not yet available for commercial use.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is the third largest branded prescription eye care business in the United States, with an expanding focus on allergy therapeutics. ISTA currently markets four products, including treatments for ocular inflammation and pain post-cataract surgery, glaucoma, and ocular itching associated with allergic conjunctivitis. The Company's development pipeline contains additional candidates in various stages of development to treat dry eye, ocular inflammation and pain, and nasal allergies. Headquartered in Irvine, California, ISTA generated revenues of $160 million in 2011. For additional information about ISTA, please visit the corporate website at www.istavision.com.
BROMDAY™ (bromfenac ophthalmic solution) 0.09%, XIBROM (bromfenac ophthalmic solution)® 0.09% and PROLENSA™ (bromfenac ophthalmic solution) are trademarks of ISTA Pharmaceuticals, Inc.
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Reform Act of 1995. Without limiting the foregoing, but by way of example, statements contained in this press release related to filing of a new drug application with the FDA are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA's expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, delays and uncertainties related to FDA actions and such other risks and uncertainties as detailed from time to time in ISTA's public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA's Annual Report on Form 10-K for the year ended December 31, 2011 and ISTA's Quarterly Report on Form 10-Q for the quarter ended March 31, 2012.