Irvine-based Allergan Inc. was dealt a minor disappointment Wednesday when regulators rejected another drug maker’s application for a chronic dry eye disease treatment.
The Food and Drug Administration said Inspire Pharmaceuticals Inc.’s diquafosol treatment failed to show statistically significant improvement as compared to placebo in testing.
Allergan saw diquafosol as a possible complement to its Restasis drug, which was approved in 2002 to treat chronic dry eye disease.
“We remain hopeful that Inspire will find a pathway to FDA approval for diquafosol since it could be synergistic with our Restasis,” said Dr. Scott Whitcup, Allergan’s Executive Vice President, Research & Development. “However, as we know from our own experience, the development of a pharmaceutical to treat chronic dry eye disease can be extremely challenging.”
Drug sales often get a boost when one treatment is shown to work with another. Allergan said that while it was disappointed, it hadn’t included diquafosol in its strategic plans.
“Given the challenges associated with the research, development and regulatory approval of dry eye pharmaceuticals, we have always taken a conservative approach,” said David E.I. Pyott, Allergan’s chairman and chief executive. “Instead, our strategic plans have focused on vigorously building Restasis, the only pharmaceutical approved by the FDA for the treatment of chronic dry eye disease.”
Shares of Allergan were down 2% to $72 midday Wednesday. Durham, N.C.-based Inspire saw its shares tumble 44% to $8.9.
