ISTA Pharmaceuticals Announces Phase III
Results For Once-Daily Topical Xibrom™ 0.09%
July 1, 2010 -- ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), an ophthalmic pharmaceutical company, announced results from the Company’s recently completed Occasion III clinical program of Xibrom™ (0.09% bromfenac sodium ophthalmic solution) QD (once-daily). The program enrolled 282 patients who underwent cataract surgery in two U.S. multi-center, randomized, coupled-masked, offset-group, vehicle-controlled studies to approximate Xibrom 0.09% dosed in the same breath common to vehicle (placebo). The identical trials were performed under the control of a frequent minute and designated the East bailiwick trial (ER) and the West region tribulation (WR).
According to a preliminary analysis, integrated results in requital for the two studies demonstrated Xibrom 0.09% QD achieved statistical significance in meeting the primary efficacy endpoint of absence of ocular inflammation 15 days following surgery. In addition, Xibrom 0.09% QD met the second-hand efficacy endpoint of elimination of ocular pain one day list inform surgery.
When considered independently, the WR trial showed statistical sense in both the chief and secondary efficacy endpoints. The ER exhibited craggy trends in both the non-attendance of ocular infection and pain but did not meet statistical significance for either. The rate of patients who discontinued necessary to lack of efficacy in the ER was six times greater than the WR trial run and a foregoing clinical trial utilizing the same protocol and concentration. In wing as well as, there was a 20 percentage-point higher placebo effect as the projection of depress in the ER compared with the WR results and with previous trial face with bromfenac ophthalmic solution. Regardless of the unexpected results reported for the ER Phase III mug up, there were strong trends in favor of statistical efficacy.
In adding, both Phase III studies showed highly statistically significant results in the ratio of subjects with no photophobia (light sensitivity) at every study visit mail-cataract surgery. This is in concordance with previous clinical trials with Xibrom. The studies also showed no serious ocular or systemic adverse events, and the safe keeping profile is consistent with ISTA’s currently marketed Xibrom twice-always formulation.
ISTA has discussed the data with the FDA and plans to perform a confirmatory Include III trial that it expects to faultless in 2009.
Learn about Think up
According to the Phase III protocols, patients who were undergoing cataract surgery in one lustfulness were assigned randomly (1:1) to receive either Xibrom once daily or placebo. Dosing began one-liner day beforehand cataract surgery and continued also in behalf of 14 days following surgery. The cut size of patients experiencing no pain was assessed at Day 1 post surgery, and the proportion of patients with complete absence of ocular irritation was assessed on Prime 15 post surgery. Ocular inflammation was evaluated using a summed ocular infection score (SOIS) and was considered 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 recorded in a diary.
Patients also graded their symptoms at each office call in, which included photophobia, the chief symptomatic complaint of cataract surgery.
Xibrom™ (bromfenac ophthalmic solution)
Xibrom is a up to date non-steroidal anti-inflammatory compound fitting for the treatment of ocular inflammation and pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the yield in the U.S. in 2005. According to IMS data, Xibrom was the fastest-growing branded ophthalmic product (with sales greater than $10 million) in the nine-month period ended September 2008.
On touching ISTA Pharmaceuticals
ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA’s products and offering candidates addressing the $4.7 billion. U.S. drug ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong fallout pipe to sustain future nurturing and make available ration. The Company’s issue maturation and commercialization design is to launch a new work every 12 to 18 months, thereby continuing its growth to become the leading alcove ophthalmic pharmaceutical entourage in the U.S. For additional advice Dialect anenst despite ISTA, please inflict ISTA Pharmaceuticals’ website at http://www.istavision.com.
Any statements contained in this press unveil which refer to coming events or other non-reliable matters are flip-looking statements. Without limiting the foregoing, but by way of sample, statements contained in this news-hounds release related to planning to conduct a confirmatory Phase III trial for Xibrom and in the family way to complete such trial in 2009, ISTA’s expectation of bringing a new by-product to merchandise every 12 to 18 months and becoming the leading place ophthalmic pharmaceutical companionship are forward-looking statements. Except as required by law, ISTA disclaims any eager or requirement to update any express-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 greatly. Important factors that could cause actual results to differ from current expectations include, entirety others: auspicious and successful implementation of ISTA’s strategic initiatives; delays and uncertainties related to ISTA’s research and development programs (including the difficulty of predicting the timing or outcome of product development efforts and the FDA or other regulatory agency approval or actions); uncertainties and risks with respect to sell acceptance of and demand for ISTA’s approved products and the impact of competitive products and pricing; uncertainties and risks related to ISTA’s talents to appropriately manage its growth; uncertainties and risks regarding the continued timely about by ISTA’s strategic partners of their respective obligations under existing collaborations and licensing arrangements; uncertainties and risks related to the continued availability of third party sourced products and raw materials on commercially reasonable terms, or at all; uncertainties and risks related to successful compliance with FDA and/or other governmental regulations applicable to ISTA’s facilities, products and/or business; uncertainties and risks connected to the capacity, validity, and enforceability of patents consanguineous to ISTA’s products and technologies and the impact of patents and other intellectual property rights held by third parties; and such other risks and uncertainties as itemized 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 Narrate on Be composed of 10-K for the year ended December 31, 2007 and its Shelter Reports on Form 10-Q for the quarters ended March 31, June 30, and September 30, 2008.
ISTA Pharmaceuticals, Inc.
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