TearSolutions has received Orphan Drug and Fast Track designations from the FDA for Lacripep in neurotrophic keratitis (NK), and has initiated a Phase 2 clinical trial with the first patients now dosed.

The Charlottesville, Virginia-based clinical-stage biotechnology company is developing Lacripep as a potential first-in-class treatment for neurotrophic keratitis, a rare degenerative corneal disease marked by reduced or absent corneal sensitivity and impaired corneal healing. The condition can lead to persistent epithelial defects and vision loss.

The FDA’s Orphan Drug designation provides development incentives, including tax credits for clinical testing and the potential for seven years of US market exclusivity if the drug is approved. Fast Track designation is designed to accelerate development and review for therapies targeting serious conditions, allowing for more frequent interaction with the FDA and the possibility of rolling review of a New Drug Application.

TearSolutions has also begun a multicenter, randomized, vehicle-controlled Phase 2 trial in the United States to assess Lacripep’s safety and efficacy in patients with neurotrophic keratitis. The study is expected to enroll approximately 54 participants.

Lacripep is a synthetic peptide derived from lacritin, a human tear protein. According to TearSolutions, preclinical and early studies suggest the therapy has dual neurotrophic and prosecretory functions, with the aim of addressing underlying nerve damage, restoring basal tear secretion, and improving corneal epithelial health.

CEO of TearSolutions, Anil Asrani, said the FDA designations represent a significant milestone and underscore the unmet need in neurotrophic keratitis. He added: "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."

Source: TearSolutions.