TearSolutions announced that the FDA has granted both Orphan Drug Designation (ODD) and Fast Track Designation to its lead investigational therapy, Lacripep, for the treatment of neurotrophic keratitis (NK). The company also announced the initiation of its phase 2 clinical trial, with the first patients now dosed.

“Receiving both Orphan Drug and Fast Track designations from the FDA is a significant milestone that underscores the unmet medical needs that still exist in neurotrophic keratitis and the potential for Lacripep to transform how this disease is treated,” said Anil Asrani, Chief Executive Officer of TearSolutions. “These designations validate our approach and afford us the opportunity to work closely with the FDA to accelerate our clinical development and bring this much-needed therapeutic option to patients sooner.”

The newly initiated phase 2 clinical trial is a multicenter, randomized, vehicle-controlled study designed to evaluate the safety and efficacy of Lacripep in patients with NK. Approximately 54 participants are expected to be enrolled across study sites in the United States. If successful, Lacripep could offer a novel therapeutic option for patients suffering from NK, a condition for which treatment choices remain limited.

Additional information about the study is available through ClinicalTrials.gov under identifier NCT07568730.