ISTA Pharmaceuticals Announces Statistically Significant Phase 3 Results for PROLENSA(TM)
ISTA Plans to File PROLENSA New Drug Application in First Quarter 2012 PROLENSA's Formulation Covered by Pending Patent Applications
IRVINE, CA, Oct 13, 2011 (MARKETWIRE via COMTEX) -- ISTA Pharmaceuticals, Inc. ISTA -3.96% , today announced statistically significant results from the company's Phase 3 clinical program for PROLENSA(TM) (bromfenac ophthalmic solution). PROLENSA is a low concentration of bromfenac in a modified ophthalmic solution developed to treat pain and inflammation associated with cataract surgery. In both Phase 3 studies, PROLENSA was statistically significantly better than placebo and met the primary efficacy endpoint of absence of ocular inflammation 14 days following surgery and the secondary efficacy endpoint of elimination of ocular pain one day post-surgery. There were no serious drug-related ocular or systemic adverse events, and PROLENSA's safety profile was found to be consistent with ISTA's currently marketed topical non-steroidal anti-inflammatory (NSAID) compound, BROMDAY(TM) (bromfenac ophthalmic solution) 0.09%.
"Our goal with the bromfenac franchise has been to deliver a safe and highly effective treatment for pain and inflammation post-cataract surgery, with the most convenient dosing schedule," stated Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals. "The new, optimized formulation used for PROLENSA enhances the penetration of the drug into ocular tissues, allowing us to lower the concentration of the active ingredient, bromfenac, while maintaining the convenience of once-daily use currently prescribed with BROMDAY. This study had the lowest number of adverse events (greater than 2%) than any of our bromfenac clinical trials for cataract surgery to date. And, to the best of our knowledge, PROLENSA contains the lowest concentration of bromfenac currently under investigation in any clinical trials for inflammation and pain associated with cataract surgery. We are very pleased with the strong clinical results for PROLENSA, as they represent an important step in extending the commercial success of our bromfenac product line. Based upon the results announced today, we plan to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for PROLENSA in the first quarter of 2012, with a commercial launch planned for late 2012 or early 2013."
Added Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA, "Assuming timely approval and commercial launch, we will focus the sales force on converting the 4,500+ ophthalmologists who prescribe the majority of the once-daily BROMDAY to prescribe PROLENSA. Because PROLENSA has a lower concentration of the active ingredient with high efficacy and safety, we plan to discontinue BROMDAY sometime after the successful launch of PROLENSA. This is the same commercial strategy successfully implemented earlier this year for conversion of our twice-daily XIBROM(TM) prescriptions to our once-daily BROMDAY."
PROLENSA is covered by patents pending in the U.S. on its formulation and method of use, with potential coverage until 2024. In addition, assuming PROLENSA is approved, the company will seek a three-year exclusivity period under the Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act.
About the Phase 3 Study
ISTA conducted two Phase 3 multi-center, randomized, double-masked, parallel-group controlled studies. Data were collected under a common protocol and conducted and analyzed as two independent studies in the U.S. Four hundred and forty (440) patients who underwent cataract surgery in one eye (unilateral) were assigned randomly (1:1) to receive either PROLENSA once daily or placebo (vehicle). Dosing began one day before cataract surgery and continued the day of the surgery and for 14 days following surgery. The proportion of patients experiencing no pain was assessed at Day 1 post surgery and throughout the study, and the proportion of patients 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 immune cells in the anterior chamber of the eye ("cells") and cellular debris ("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.
The studies' protocol and positive results were highly similar to those seen in previous Phase 3 trials for ISTA's current marketed drug, once-daily BROMDAY(TM) (bromfenac ophthalmic solution) 0.09%.
ABOUT PROLENSA(TM)
PROLENSA(TM) (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, in a new formulation. From 2005 until 2011, ISTA marketed XIBROM (bromfenac ophthalmic solution)(R) 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 on February 28, 2011. ISTA acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. BROMDAY is currently the only once-daily treatment option in the $350 million U.S. ophthalmic nonsteroidal anti-inflammatory market. PROLENSA is an investigational drug and not yet available for commercial use.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is a fast growing and 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 $156.5 million in 2010. For additional information about ISTA, please visit the corporate website at www.istavision.com .
PROLENSA(TM) (bromfenac ophthalmic solution), BROMDAY(TM) (bromfenac ophthalmic solution) 0.09% and XIBROM (bromfenac ophthalmic solution)(R) 0.09% are trademarks of ISTA Pharmaceuticals, Inc.
Full prescribing information for BROMDAY is available on ISTA Pharmaceuticals' website at http://www.istavision.com/pdf/BROMDAYPI101008.pdf
FORWARD-LOOKING STATEMENTS
Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release that refer to the initiation and completion of NDA filings for PROLENSA, the potential for PROLENSA receiving NDA approval, potential launch dates for PROLENSA, and potential patent grants and Hatch-Waxman exclusivity covering PROLENSA 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 the timing of NDA filings, the FDA or other regulatory agency approval or actions, uncertainties regarding the scope and timing of patent issuances (if any) 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, 2010, and Forms 10-Q for quarters-ended March 31, and June 30, 2011.