ISTA Pharmaceuticals Initiates Phase 3 Clinical Program for REMURA in Dry Eye Disease
- FDA Agrees to Special Protocol Assessment -
IRVINE, Calif., Sept. 16 /PRNewswire/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), today announced that it has initiated a Phase 3 clinical program of ISTA's proprietary formulation of REMURATM (bromfenac ophthalmic solution for dry eye) for alleviating the signs and symptoms of dry eye disease. The Phase 3 efficacy studies are being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).
"We are pleased by the initiation of our pivotal REMURA dry eye efficacy program. Further, reaching agreement with the FDA on the SPA for REMURA efficacy studies provides additional clarity regarding the path to approval, which will help us to bring a safe and effective treatment to patients suffering from dry eye," stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. "Dry eye is a large and growing market, with 2010 worldwide prescription sales expected to be about $600 million. Dry eye also is an underserved market, as patients suffering from chronic dry eye syndrome have few quality therapy options. We are very excited by the potential of REMURA as a new treatment modality for dry eye patients."
At this time, ISTA plans to assess the safety and efficacy of REMURA in alleviating the signs and symptoms of dry eye disease by conducting four randomized, double-masked, placebo-controlled Phase 3 studies. The recently initiated Phase 3 studies will evaluate the efficacy and safety of bromfenac in two simultaneous studies operating under a common protocol in approximately 1000 patients with mild or moderate dry eye disease. The multi-center trials will be conducted at more than 30 sites in the U.S. Two concentrations of bromfenac (both lower than the currently marketed Xibrom (bromfenac ophthalmic solution)® 0.09%), will be dosed in addition to placebo. Patients will be randomized at a ratio of 1:1:1 to receive either bromfenac or placebo in both eyes twice daily and will be evaluated over the course of 42 days. For both efficacy studies, the objective sign of conjunctival staining will be measured using the Lissamine Green test and subjective symptoms will be measured using the Ocular Surface Disease Index (OSDI). ISTA anticipates reporting results in the middle of 2011.
The two remaining Phase 3 safety studies are the subject of additional SPAs currently under review by the FDA. To meet FDA guidance on drugs for chronic dosing, the Company expects to conduct both a six-month and a twelve-month safety study. ISTA anticipates it will initiate one or both of these safety studies later this year, subject to reaching agreement with the FDA on the SPAs.
ABOUT DRY EYE DISEASE
Dry eye occurs when there is an imbalance of tears that provides moisture and lubrication to the eye, which can result in pain, itching, redness, blurry vision, light sensitivity and/or a gritty sensation or feeling of sand in the eye. Causes for dry eye include environmental conditions such as air conditioning, smoke and dust, aging and menopause, side-effects from antihistamines and birth control pills, Sjogren's syndrome, rheumatoid arthritis and structural problems with the eye lid's ability to close. Left untreated, dry eye can lead to abrasions on the surface of the eye and damage to the cornea. Current treatments include artificial tears and ointments, topical steroids, a topical immunomodulator that is the only approved prescription eye drop treatment and punctal occlusion (closing or plugging of tear drains).
ABOUT BROMFENAC OPHTHALMIC SOLUTION
REMURA (bromfenac ophthalmic solution for dry eye) is a sterile, topical non-steroidal anti-inflammatory (NSAID) compound under investigation for use as an ophthalmic agent to alleviate the signs and symptoms of dry eye disease. Since 2005, ISTA has 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. ISTA acquired U.S. ophthalmic rights to bromfenac in May 2002 under a license from Senju Pharmaceuticals Co. Ltd. ISTA is currently awaiting FDA approval (with an FDA action date of October 16, 2010) for BROMDAYTM, a once-daily bromfenac ophthalmic solution for the treatment of ocular inflammation and pain associated with cataract surgery.
ABOUT ISTA PHARMACEUTICALS
ISTA Pharmaceuticals, Inc. is the fourth largest and fastest growing 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, the Company generated 2009 revenues of $111 million. For additional information about ISTA Pharmaceuticals, please visit the corporate website at www.istavision.com.
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 related to the expected initiation and completion of the Phase 3 study of REMURA (bromfenac ophthalmic solution for dry eye) and the FDA's review and approval of BROMDAY, a once-daily formulation of bromfenac ophthalmic solution for ocular inflammation and pain associated with cataract surgery, 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 and success of clinical trials and FDA or other regulatory agency approval or 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, 2009, and its Quarterly Report on Forms 10-Q for the second quarter ended June 30, 2010.