Key Developments For Ista Pharmaceuticals Inc
Ista Pharmaceuticals Inc (ISTA.O) (Consolidated Issue listed on NASDAQ Global Market)
ISTA Pharmaceuticals Highlights Bepreve Clinical Data At 2009 Annual Meeting Of the American College Of Allergy, Asthma & Immunology
ISTA Pharmaceuticals announced additional results from the Company's Bepreve (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies. In a poster presentation titled, 'Treatment of Ocular Itching with Bepotastine Besilate Ophthalmic Solution 1.5% for Subjects with More Severe Itching Response in a Conjunctival Allergen Challenge (CAC) Clinical Model of Allergic Conjunctivitis,' integrated results from two Phase 3 studies demonstrated Bepreve 1.5% was as effective in suppressing ocular itching in patients with more severe itching as in patients with all grades of ocular itching. A total of 157 patients were enrolled in two 7-week, masked, randomized, placebo-controlled CAC clinical studies (1 single site, 1 multi-site). 113 patients exhibited bilateral ocular itching grades greater than or equal to 3 at screening during study visit 2. Individuals were assessed at 15 minutes, 8 hours, or 16 hours following instillation at study visits spaced 2 weeks apart during the enrollment period. The difference in mean itching grades (placebo-active) for the more severely affected subjects was within plus or minus 0.1 unit of the differences for the entire intent-to-treat (ITT) population. Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Nasal Congestion with Rapid Onset in a Clinical Model of Allergic Conjunctivitis.
ISTA Pharmaceuticals Raises FY 2009 Revenue Outlook; Issues FY 2009 Earnings Outlook; EBIT Outlook Below Analysts' Estimates
ISTA Pharmaceuticals updated its fiscal 2009 outlook and expects total net revenue including net product revenue of $106-$109 million, expects operating income (EBIT) to be approximately breakeven and net loss to be approximately $7-$10 million. According to Reuters Estimates, analysts were expecting the Company to report revenues of $104 million, EBIT loss of $1.41 million and net loss of $8 million for the same period.
ISTA Pharmaceuticals Announces Bepreve Clinical Data At American College of Clinical Pharmacy (ACCP) 2009 Annual Meeting
ISTA Pharmaceuticals announced the poster presentations of results from the Company's Bepreve (bepotastine besilate ophthalmic solution) 1.5% Phase 3 clinical studies in allergic conjunctivitis. The studies demonstrated Bepreve was safe and well-tolerated when given twice daily for six weeks in a healthy pediatric population as young as three years of age. In a poster previously presented at the American Academy of Allergy Asthma & Immunology 2009 Annual Meeting titled, The Ocular Comfort and Safety of an Anti-Histamine Bepotastine Besilate Ophthalmic Solution 1.5% in a Healthy Pediatric Population, ISTA presented results from a six week, multi-center, randomized, double-masked, placebo-controlled, parallel-group safety study. The study enrolled 861 individuals, of whom approximately 15% (127 subjects) were pediatric subjects. Subjects were randomized to receive either Bepreve or placebo twice daily. Following test drop instillation for each eye at study visit 2 (one week of dosing) and visit 3 (three weeks of dosing), the overall comfort of the investigational product was graded using a quantitative scale. The study showed there was no clinically or statistically significant difference in the ocular comfort of Bepreve and placebo among pediatric subjects, either immediately after or five minutes following instillation.
ISTA Pharmaceuticals Raises FY 2009 Revenue Guidance; Reaffirms FY 2009 Earnings Guidance
ISTA Pharmaceuticals raised fiscal 2009 guidance for total net revenue, including net product revenue of $101 to $104 million and $2.9 million from the one-time recognition of deferred revenue resulting from modification of partnership with Otsuka, to be in the range of $104 to $107 million. The Company reiterated its guidance for operating income to be neutral in fiscal 2009. According to Reuters Estimates, analysts on an average were expecting the Company to report revenue of $100 million for the same period.
ISTA Pharmaceuticals's Bepreve Receives FDA Approval for Treatment of Ocular Itching Due to Allergies
ISTA Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has approved Bepreve (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.
