IRVINE, CA -- (Marketwire) -- 05/01/12 -- ISTA Pharmaceuticals, Inc. (NASDAQ: ISTA) announced today positive results from its Phase 2 randomized, placebo-controlled, parallel-group environmental clinical study of BEPOSONE (bepotastine besilate/steroid) nasal spray for the treatment of symptoms associated with seasonal allergic rhinitis, the inflammation of the nasal passages caused by allergies. According to the trial findings, BEPOSONE nasal spray showed highly statistically significant improvements compared to placebo in patients' nasal symptoms following exposure to one of the most potent seasonal allergy triggers, Mountain Cedar pollen. These improvements were seen as early as Day 1 of therapy and were sustained through the two-week treatment period. Statistically significant improvement was also seen for BEPOSONE within 15 minutes after dosing in a small subgroup of subjects who frequently evaluated their nasal symptoms for 4 hours after their first nasal spray dose. Further, safety data demonstrated BEPOSONE was well-tolerated as a nasal spray, with an adverse event profile similar to placebo and generally consistent with those observed with bepotastine besilate dosed as a nasal spray in prior clinical trials and with other antihistamine nasal sprays.
"We are very encouraged by the results of the BEPOSONE Phase 2 pilot study, which shows promise for the use of a combination bepotastine besilate/steroid nasal spray for treatment of allergic rhinitis. Since antihistamines and steroids are often prescribed at the same time to patients for the treatment of seasonal allergic rhinitis, we believe there is a need for a combination product that brings together these two effective treatments in one convenient nasal spray formulation," commented Timothy R. McNamara, Pharm.D., Vice President of Clinical Research and Medical Affairs of ISTA Pharmaceuticals.
Dr. McNamara continued, "We designed our Phase 2 study to be similar to what we would expect to be required of a Phase 3 spring or fall natural allergen exposure environmental study. The study was intended to provide key information for making strategic decisions on appropriate Phase 3 study designs with our bepotastine besilate nasal spray franchise. Based on these results and the positive Phase 2 results from our single-agent antihistamine nasal spray of bepotastine besilate, BEPOMAX, which were reported last year, we expect to complete some additional Phase 2 studies ahead of our Phase 3 pivotal program covering both products, slated to begin in 2013. BEPOSONE and BEPOMAX represent exciting potential expansions of our prescription allergy product line, currently focused on BEPREVE® (bepotastine besilate ophthalmic solution) 1.5% for the treatment of ocular itching associated with allergic conjunctivitis."
ABOUT THE PHASE 2 BEPOSONE NASAL SPRAY CLINICAL TRIAL AND TRIAL RESULTS
The Phase 2 trial was a randomized, multi-center, double-masked, placebo-controlled, parallel-group environmental trial to evaluate the safety and efficacy of BEPOSONE, dosed twice daily, in patients presenting with allergic rhinitis caused by Mountain Cedar pollen.
Following initial screening for evidence of Mountain Cedar pollen allergy, approximately 600 patients in Texas, aged 12 years and older, were treated twice per day for two weeks with one of four formulations: bepotastine besilate/steroid combination nasal spray (BEPOSONE), a nasal spray containing one or the other of the two active agents, or placebo nasal spray. Patients graded both individual nasal and ocular symptoms on a twice-daily basis during the treatment period. The mean grades for responses to questions in the validated Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) were completed at the beginning and end of the trial as a surrogate measure of clinical benefit.
Safety was evaluated based on several variables, including recording of adverse events, physical and nasal examinations, ECG measurements and determination of pharmacokinetic parameters in a prospectively identified subpopulation, and monitoring of vital signs.
The clinical study showed BEPOSONE nasal spray provided highly statistically significant improvement compared to placebo in reducing total nasal symptoms. Each of the active agents alone, the steroid and the antihistamine, also provided improvement in nasal symptoms that was greater than placebo nasal spray and was approximately additive to the level of improvement over placebo seen with the combination in BEPOSONE nasal spray. Nasal symptom improvement superior to placebo was seen as early as Day 1 of treatment with BEPOSONE and bepotastine nasal sprays, and with steroid nasal spray beginning on Day 3. Changes in mean RQLQ grades for BEPOSONE and single agent nasal sprays over the 2-week treatment period were also significantly better for overall quality of life (QOL) improvements and for improvements in most or all individual QOL domain grades than for changes seen with placebo nasal spray.
In regard to safety, the total number of adverse events was slightly greater in treatment groups administering bepotastine-containing nasal sprays, with the most common adverse events reported being taste, nasal discomfort, headache, and nosebleed. These adverse events were generally mild. Additionally, no serious adverse events were observed during the Phase 2 study.
ISTA expects to report comprehensive data from the BEPOSONE Phase 2 Mountain Cedar pollen trial at an appropriate, peer-reviewed forum in the future.
ABOUT THE ALLERGIC RHINITIS MARKET
According to the American Academy of Allergy Asthma & Immunology (AAAAI), approximately 60 million Americans are affected by allergic rhinitis, an inflammation of the nasal passages caused by exposure to certain allergens, such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Allergic rhinitis is characterized by a number of symptoms, including sneezing, nasal congestion, nasal itching and runny nose. The eyes, ears, sinuses and throat also can be affected. Current treatments for allergic rhinitis include antihistamines, mast cell stabilizers, anti-inflammatory medications, and steroids. Based on data from IMS Health in the U.S., approximately 46.8 million prescriptions were filled for nasal allergy treatments in 2011, resulting in sales of approximately $2.5 billion.
ABOUT BEPOTASTINE BESILATE
Bepotastine besilate is a non-sedating, highly selective antagonist of the histamine H1 receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound's primary mechanisms of action suggest that it is a potentially effective treatment for nasal symptoms associated with seasonal allergic rhinitis.
Bepotastine besilate has been approved in Japan for systemic use in the treatment of allergic rhinitis since 2000 and for urticaria/dermal prurituses since 2002. It is marketed as an oral tablet in Japan by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION®. TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine besilate. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine besilate for ophthalmic use. In 2006, ISTA licensed the exclusive North American ophthalmic rights to bepotastine besilate from Senju. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine besilate from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine besilate for allergy treatment.
ISTA's eye drop formulation of bepotastine besilate, BEPREVE® (bepotastine besilate ophthalmic solution) 1.5%, was approved by the U.S. Food and Drug Administration (FDA) in September 2009 for the treatment of ocular itching associated with allergic conjunctivitis. BEPOSONE and BEPOMAX nasal spray formulations for seasonal allergic rhinitis are currently investigational drugs in clinical studies and are 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. ISTA'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.
BEPREVE®, BEPOSONE and BEPOMAX are trademarks owned by ISTA Pharmaceuticals, Inc. TALION® is a trademark of Mitsubishi Tanabe Pharma Corporation.
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 the initiation of further studies and Phase 3 trials for BEPOSONE and/or BEPOMAX, and presentation and potential implications of Phase 2 clinical trial results 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 are 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.