June 24, 2009 / 1:18 PM / 10 years ago

UPDATE 3-US FDA staff: No big safety issues with Ista drug

 * Drug under review for treating allergy-related eye itch
 * Advisory panel meets Friday to evaluate data
 * Ista shares gain more than 5 pct
 (Adds analyst comments, updates share movement)
 By Lisa Richwine
 WASHINGTON, June 24 (Reuters) - No serious safety problems
were reported in studies of Ista Pharmaceuticals Inc's ISTA.O
proposed eye drops for allergy-related itching, U.S. drug
reviewers said in documents released on Wednesday.
 In one study that evaluated risks, 25 percent of patients
treated with the drug reported a change in taste, such as a
bitter taste or aftertaste, said staff in the Food and Drug
Administration division that reviews eye drugs.
 The analysis was prepared for an advisory panel that meets
Friday to consider if adequate safety and effectiveness has
been shown for the drug, called Bepreve.
 Shares of Ista gained 5.5 percent in afternoon trading to
$3.99 on the Nasdaq.
 Several medicines are approved for treating allergies, but
Ista said there was a need for new options with fewer side
effects. Approved drugs may cause sleepiness, dry mouth and
other problems.
 Bepreve reduced eye itching "with few mild and transient"
side effects, the company said in a separate summary released
by the FDA.
 SunTrust Robinson Humphrey analyst Frank Pinkerton has
forecast Bepreve sales of $12 million in 2010 if the drug wins
approval for U.S. sales.
 The advisory panel, a group of outside experts, will
discuss whether adequate evidence of safety and effectiveness
was provided for Bepreve as well as for another drug, River
Plate Biotechnology's proposed solution to treat dry eye.
 FDA reviewers, in a separate analysis prepared for the
meeting, said they had identified "three major statistical
issues" in River Plate's application to market a hyaluronate
sodium solution under the name Rejena.
 One of the company's key studies lacked a "robust treatment
effect" for the product, the reviewers said. An earlier study
failed to meet its main goal to show effectiveness and an FDA
reviewer could not replicate the company's finding that
secondary goals were met, the FDA staff said.
 Alcon Inc ACL.N holds U.S. marketing rights for the River
Plate drug. The product already is sold in Europe.
 In a separate summary, River Plate said there was
"compelling and scientifically thorough evidence" of
effectiveness, safety was "widely established" and the drug's
"benefit-to-risk evaluation is overwhelmingly positive."
 UBS analyst Marc Goodman, in a research note, said there
was a "strong likelihood" the FDA panel would recommend against
approval of the River Plate drug and might urge additional
studies. Goodman said he had no sales forecast for the drug and
maintained a "strong positive view" of Alcon overall.
 The FDA will consider the advisory panel's input before
deciding whether to approve the drugs. The agency usually
follows panel recommendations.
 Alcon shares were up 0.2 percent at $113.68 on the New York
Stock Exchange on Wednesday afternoon.
 The FDA posted the meeting documents here.
 (Reporting by Lisa Richwine; Editing by Lisa Von Ahn, Gerald
E. McCormick and Matthew Lewis)


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