ISTA Pharmaceuticals, Inc. announced that it has initiated a phase 3 clinical programme of ISTA's proprietary formulation of Remura (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 US Food and Drug Administration (FDA).

"We are pleased by the initiation of our pivotal Remura dry eye efficacy programme. 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-centre trials will be conducted at more than 30 sites in the US. Two concentrations of bromfenac (both lower than the currently marketed Xibrom (bromfenac ophthalmic solution) 0.09 per cent), 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.

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).

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)(R) 0.09% in the US 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 US 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 Bromday, a once-daily bromfenac ophthalmic solution for the treatment of ocular inflammation and pain associated with cataract surgery.

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.