Inspire Pharmaceuticals moved a step closer this morning to bringing its dry-eye drug to market when it announced its intent to file a new drug application with the Federal Drug Administration.
In a statement, Inspire said the company met with FDA representatives on Oct. 29 to discuss INS365 Ophtlalmic and to review test data.
“This is a major breakthrough for our dry eye program,” stated Christy Shaffer, CEO of Inspire. “We have been pleased with the ongoing guidance we have received from the FDA. These discussions have been helpful in defining the pathway for the NDA filing. We are in the process of scheduling a pre-NDA meeting, which will likely take place within the next few months. We will provide further details on the timing of the NDA filing following the pre-NDA meeting.”