ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA), presented results from the Company’s Bepreve(TM) (bepotastine besilate ophthalmic solution) Phase 3 pivotal clinical studies using the Conjunctival Allergen Challenge (CAC) model of allergic conjunctivitis. The studies demonstrated Bepreve 1.5% was effective at reducing ocular itching for at least 8 hours after dosing, with high statistical significance for improvement in ocular itching compared to placebo for up to 16 hours after dosing. In addition, there was evidence that Bepreve 1.5% substantially reduces tearing caused by a conjunctival allergen challenge for at least 8 hours after dosing. In addition, ISTA demonstrated Bepreve 1.5%, dosed twice daily for six weeks, was safe with minimal adverse events in a healthy pediatric population from 10-17 years of age. Results were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting in Ft. Lauderdale, FL.

In the poster presentation titled “Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Ocular Itching Following Dosing in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis”, ISTA demonstrated positive results from two 7-week, masked, randomized, placebo-controlled CAC clinical studies (1 single site, 1 multi-site). The two studies enrolled a total of 157 patients in the placebo and Bepreve 1.5% treatment groups. The study showed Bepreve 1.5% dosed in both eyes was clinically effective in reducing ocular itching associated with allergic conjunctivitis in the CAC model for at least 8 hours after dosing and statistically superior to placebo in reducing ocular itching at CAC tests conducted 15 minutes, 8 hours, and 16 hours after dosing (P<0.0001). The 8 hour and 16 hour measurements correlate with accepted standards for efficacy as a twice-a-day and once-a-day drop respectively.

In a separate poster presentation titled “Bepotastine Besilate Ophthalmic Solution 1.5% Reduces Tearing at 8 Hours Following Dosing in a Multi-Site Clinical Trial Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis”, ISTA demonstrated positive results from a multi-center, double-masked, placebo-controlled, clinical study with 86 patients who were randomized to receive either Bepreve 1.5% or placebo in both eyes in three CAC tests spaced two weeks apart. The results showed Bepreve 1.5% was statistically superior to placebo for at least 8 hours after ophthalmic dosing for reducing CAC-induced tearing.

In another poster presentation titled “The Safety of the Anti-Histamine Bepotastine Besilate Ophthalmic Solution in a Healthy Pediatric Population from Ten to Seventeen Years of Age”, ISTA demonstrated Bepreve 1.5% dosed in both eyes twice daily for six weeks was safe in a healthy pediatric population from 10-17 years of age. The pediatric subjects in this age group (n = 45) were among 861 patients enrolled in this masked, randomized, placebo-controlled clinical trial, with a randomization of 2:1 (Bepreve 1.5%:placebo). The proportion of subjects in the Bepreve 1.5% treatment group with an adverse event (22.5%) was very similar to that seen for subjects instilling placebo (20.0%). No serious adverse events were reported during the clinical trial for any pediatric subject.

Earlier in the week, the Company presented additional results from clinical studies with Bepreve 1.0%, as well as data from a clinical study with the Company’s Xibrom(TM) (bromfenac ophthalmic solution 0.09%) product and laboratory results with Vitrase(R) (hyaluronidase injection). The results were presented in the following poster presentations:

Bepotastine Besilate Ophthalmic Solution 1.0% Rapidly Reduces Conjunctival Hyperemia in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Authors: J.A. Gow, G.L. Torkildsen, J.I. Williams, P.J. Gomes, M.B. Abelson, T.R. McNamara

Bromfenac for the Treatment of Chronic Pseudophakic Cystoid Macular Edema

Author: E.F. Kadrmas

Stability of Vitrase(R) Solutions after Dilution in Anesthetics

Authors: B.A. Aird, J.D. Dahlstrom, G.A. Baklayan, J.A. Gow

About ISTA Pharmaceuticals

ISTA Pharmaceuticals is an ophthalmic pharmaceutical company. ISTA’s products and product candidates addressing the $5.1 billion U.S. prescription ophthalmic industry include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company currently markets three products and is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S

Source: ISTA Pharmaceuticals, Inc

View drug information on Bromfenac.

WASHINGTON, May 7 — Test kits used to diagnose myocardial infarctions have been recalled by their manufacturer, the FDA announced today.

A single lot of Biosite’s Triage Cardiac Panel, a blood test for troponin I, CK-MB, and myoglobin, distributed in January and February of this year, may lead to false negative results, the company said.

The recall applies to test kits identified as catalog number 97000HS and lot #W44467B, shipped as 25 individually pouched devices per kit box.

“Although there have been no reported issues of patient misdiagnosis associated with this lot to date, low recovery may lead to reporting of falsely low values for CK-MB, troponin I, and myoglobin,” according to Biosite. The company said it was investigating the underlying cause.

A false negative test result would indicate that a person has not had a heart attack or heart muscle injury when in fact they have, the FDA said.

The FDA designated the recall as Class I, the most serious type because there is a reasonable probability that use of these products will cause serious injury or death.

The product’s instructions indicate that results of the Triage Cardiac Panel should not be used as absolute evidence of myocardial infarction. Diagnoses should be made in the context of all the clinical and laboratory data available, according to Biosite.

Related source:

FDA announcement of recall

Amarin Corporation plc (NASDAQ:AMRN) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for its planned Phase 3 registration clinical trial of AMR101 (ethyl-EPA) in patients with hypertriglyceridemia, or very high triglyceride levels. The SPA is a written agreement between the Company, as the trial’s sponsor, and the FDA regarding the design, endpoints, and planned statistical analysis of the Phase 3 trial to be used in support of a New Drug Application (NDA).

Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented “Receiving FDA agreement on the Phase 3 trial represents an important milestone for Amarin. We now look forward to commencing this Phase 3 trial shortly.”

Pursuant to the SPA, the Phase 3 trial will be a multi-center, placebo-controlled, randomized, double-blind, 12-week study to evaluate the efficacy and safety of two doses of AMR101, a prescription grade Omega-3 fatty acid, in patients with fasting triglyceride levels of ?500 mg/dL (the AMR101 MARINE Study). The primary endpoint in the trial is the percentage change in triglyceride level from baseline to week 12. Following completion of the 12-week double-blind treatment period, patients will be eligible to enter a 40-week, open-label, extension period.

The trial is expected to enroll approximately 240 patients, with enrolment planned to commence in mid-2009. The trial will be conducted in centers throughout North and Central America, Europe, India and South Africa. The Company plans to use the results of this Phase 3 registration trial as the basis for the submission of an NDA to the FDA.

In addition to the AMR101 MARINE study, Amarin is also planning to conduct a Phase 3 trial with AMR101 in patients with high triglyceride levels (?200 mg/dL and ?500 mg/dL) who are on statin therapy.

Amarin has worked closely with its Cardiovascular Advisory Group in designing these trials. The Advisory Group, consisting of leading experts in the field of cardiovascular disease research and development, comprises: Dr. Harold Bays, Medical Director and President of Louisville Metabolic and Atherosclerosis Research Center; Professor Philip Calder, Nutritional Immunology at the University of Southampton, UK; Dr. Michael Criqui, Professor and Chief, Division of Preventive Medicine, in the Department of Family and Preventive Medicine at the University of California, San Diego School of Medicine; Dr. Meredith Hawkins, Professor of Medicine and Director of the Global Diabetes Initiative at the Albert Einstein College of Medicine in New York; Dr. Sotirios Tsimikas, Professor of Medicine and Director of Vascular Medicine at the University of California, San Diego and Dr. Anthony Wierzbicki, Consultant in Chemical Pathology/Metabolic Medicine at Guy’s and St Thomas’ Hospitals NHS, UK.

About AMR101

AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (ethyl-EPA). Amarin has developed a substantial body of data on AMR101 to date. Amarin has previously investigated AMR101 in central nervous system (CNS) disorders in several double-blind, placebo-controlled studies, including Phase 3 trials in Huntington’s disease. Over 900 patients have received AMR101 in these studies, with over 100 receiving continuous treatment for one year or more. In all studies performed to date, AMR101 has shown a very good safety profile.

Numerous independent studies have demonstrated the safety, tolerability and efficacy of ethyl-EPA in lowering plasma triglycerides in patients with high triglyceride levels of varying degrees of severity. In Japan, an ethyl-EPA prescription product has been approved for the treatment of hyperlipidemia and has been on the market for seventeen years.

About Hypertriglyceridemia

Hypertriglyceridemia refers to a condition in which patients have high blood levels of triglycerides and is associated with increased risk of heart disease. It is one component of a range of lipid disorders collectively referred to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed to be in excess of 100 million, with over 10 million of those diagnosed with hypertriglyceridemia.

Source
Amarin Corporation plc

WHEELING, W.Va., May 7 — More than 80% of the cases of West Nile virus that tested positive in 2008 with a now-recalled serological test kit have not been confirmed with retesting.

The diagnosis was confirmed in only 45 of 249 patients (18%) reported to the ArboNet surveillance system as having West Nile virus, according to a report in the May 8 issue of Morbidity and Mortality Weekly Report.

Retesting refuted the diagnosis in 77 cases (31%) and the remaining cases were not retested, said the report, authored by 20 investigators from state public health departments, the FDA, and the CDC.

Another 269 cases with positive results from the suspect kits showed no illness compatible with West Nile virus infection and were never reported to ArboNet, according to the report.

The CDC’s final case count for symptomatic West Nile virus infections in 2008 now stands at 1,356, after false-positives were removed from earlier tallies.

Two lots of West Nile virus serological test kits sold by Inverness Medical under its PanBio brand were recalled on Oct. 8, 2008, following reports that the tests were prone to false positive results.

In early September, for example, a New York state public health lab found that 13 of 15 specimens testing positive with a PanBio kit were negative on retesting with a different assay.

One of the recalled lots was distributed only in Canada; the other was shipped from July to September 2008 to four U.S. labs, including one that received specimens from healthcare providers and hospitals throughout the country.

The investigation found that 568 specimens from 518 patients had been tested with the affected kits.

One-third of the patients for whom clinical information was recorded had no symptoms consistent with West Nile virus disease, the report said.

In an accompanying unsigned commentary, MMWR editors pointed out that such testing is inappropriate for asymptomatic individuals.

“Healthcare providers should consider that commercially available WNV IgM kits are only intended to help provide a presumptive diagnosis of WNV neuroinvasive disease when requesting testing and interpreting the results,” the editors wrote.

They also upbraided laboratories for the low rate of confirmation testing that had been performed — less than 10% of samples before the investigation of the false-positives began.

“Commercial laboratories should work with public health laboratories to ensure that confirmatory testing is performed on all presumptive positive results,” the editorial said.

The revised 2008 numbers come in at less than half the 3,360 cases of West Nile virus reported in 2007.