Shares of Inspire Pharmaceuticals lost one-third of their value in premarket trading after it was announced that the FDA found their data for the dry eye therapy diquafosol tetrasodium insufficient to warrant an approval. The agency outlined steps needed to gain a green light for diquafosol tetrasodium and urged a meeting to plan a way forward for the company. Inspire has been waiting for more than two years for approval of the drug. Allergan, which sells the dry eye treatment Restasis, had been working with Inspire to bring the new drug to market.
The FDA's letter stated that "[t]he submitted clinical studies fail to demonstrate adequate replication of results for the efficacy endpoints and therefore are insufficient to establish efficacy. Based on our review of the submitted data, consistent findings of corneal clearing need to be demonstrated to support the efficacy of the drug product."
- read this AP report for more information