IRVINE, Calif., Sept. 27 /PRNewswire-FirstCall/ -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) today highlighted results from the Company's REMURA™ (bromfenac ophthalmic solution for dry eye) Phase 2 clinical study. The study achieved statistical significance in the primary endpoint of the objective sign of conjunctival staining (p<0.001) as compared to baseline. The study also achieved statistical significance on the objective sign of corneal staining (p<0.01) as compared to baseline. In addition, patients achieved statistically significant improvements in subjective symptoms measured by the Ocular Surface Disease Index* (OSDI) (p<0.001) and in patients' most bothersome ocular symptoms. Patients treated with REMURA maintained the improvements in the signs and symptoms of dry eye disease for 10 days after discontinuing treatment, which was evaluated at the time of the follow up visit. Adverse events were uncommon, and there were no serious ocular or systemic adverse events.
These results were presented in poster sessions at the 6th International Conference on the Tear Film & Ocular Surface in Florence, Italy, in poster presentations titled "Bromfenac Ophthalmic Solution for Treating the Signs of Dry Eye Disease" and "Alleviation of Dry Eye Disease Symptoms with Bromfenac Ophthalmic Solution."
ISTA's REMURA Phase 2 study enrolled 38 patients who exhibited signs and symptoms consistent with moderate dry eye disease. The study was designed to investigate the effects of REMURA compared to baseline on the objective signs of conjunctival staining (Lissamine Green test) and corneal staining (Fluorescein test), as well as subjective symptoms (OSDI and patients' most bothersome ocular symptoms), when administered under normal environmental conditions. All patients received REMURA in both eyes, twice daily, for 42 days. Patient baseline scores were recorded prior to the first treatment with REMURA and were compared to scores at Day 14, Day 42 and Day 52.
Authors of the posters were Simon P. Chandler, Ph.D., James A. Gow, M.D. and Timothy R. McNamara, Pharm.D. of ISTA Pharmaceuticals, Inc., Irvine, CA, USA; Sheri L. Rowen, M.D., of the Mercy Medical Eye and Cosmetic Surgery Center, Baltimore, MD, USA; and Neal A. Sher, M.D., F.A.C.S., Partner, Eye Care Associates, Minneapolis, MN, USA.
ISTA recently announced the Company has initiated its REMURA Phase 3 clinical study program. Two Phase 3 studies to evaluate the efficacy and safety of REMURA are being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA), and two remaining Phase 3 safety studies are the subject of additional SPAs currently under review by the FDA. ISTA anticipates starting the remaining safety studies later this year and reporting results for the first two Phase 3 efficacy and safety studies in the middle of 2011.
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 REMURA AND 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 currently is awaiting FDA approval (with an FDA action date of October 16, 2010) for BROMDAY™ (formerly referred to as XiDay), a once-daily bromfenac ophthalmic solution for the treatment of post-operative 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 studies 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 post-operative 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.
*Ocular Surface Disease Index, or OSDI, is a copyright of Allergan, Inc.
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