A new-to-market compounded version of Allergan Plc’s blockbuster dry-eye treatment Restasis could put patients at risk, Allergan said Oct. 20.
San Diego-based ophthalmic pharmaceutical company Imprimis Pharmaceuticals Inc. announced it planned to launch a cheaper, compounded version of the Allergan blockbuster, which pulled in $1.4 billion in U.S. sales last year.
But health-care providers and patients need to be wary, Allergan said, because the Imprimis product isn’t required to go through clinical trials nor is it subject to FDA review.
“Allergan fully recognizes the value and legitimacy of traditional and legal compounding efforts,” Mark Marmur, director of corporate affairs for Allergan in Parsippany, N.J., told me in an email.
Because the Imprimis drug is compounded, patients would need to get a prescription to obtain the drug.
But Imprimis’s compounding model is large-scale, not small-scale, Marmur said. “Imprimis’ compounding business model involves mass manufacturing and distribution of unapproved new drugs under the guise of compounding,” Marmur said, and could expose patients to drugs and combinations of drugs that haven’t been shown to be safe or effective.
“If successful in bringing forward a product, Imprimis’ compounded cyclosporine-based formulation will have not been tested in controlled trials, FDA reviewed or approved, potentially placing patients and customers at significant risk,” Marmur said.
Imprimis said its product is made from Food and Drug Administration-approved drug components and compounded in FDA-inspected facilities, which are subject to specific manufacturing controls.
Approximately 30 million Americans may have dry-eye disease, which is characterized by irritated, gritty, scratchy or burning eyes and blurred vision.
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