As reported on Business Wire, TearSolutions, a clinical-stage biotechnology company focused on ophthalmic therapies, has announced key regulatory and clinical progress for its investigational drug Lacripep® in the treatment of neurotrophic keratitis (NK). The company has secured both Orphan Drug Designation and Fast Track status from the U.S. Food and Drug Administration (FDA) and has initiated a Phase 2 clinical trial, with the first patients already enrolled and treated.
Neurotrophic keratitis is an uncommon but serious degenerative condition of the cornea marked by diminished or absent corneal sensitivity. This impairment disrupts normal healing processes, increasing the risk of persistent epithelial defects, ulceration, and ultimately vision loss. Current treatment options remain limited, underscoring the need for innovative therapies.
The FDA’s Orphan Drug Designation is granted to therapies targeting rare diseases and provides development incentives such as tax credits, assistance with clinical trial design, and up to seven years of market exclusivity if the product is approved. In parallel, Fast Track designation is intended to accelerate the development of therapies addressing serious conditions by enabling closer collaboration with the FDA and allowing for rolling submission of regulatory applications.
Company leadership emphasized that receiving both designations highlights the significant unmet need in NK and reinforces the therapeutic promise of Lacripep. These regulatory pathways are expected to help streamline development and potentially shorten the timeline to bring the therapy to patients.
The newly launched Phase 2 study is designed as a randomized, multicenter, vehicle-controlled trial evaluating both efficacy and safety of Lacripep in individuals diagnosed with NK. Approximately 54 participants are expected to be enrolled across U.S. sites. The study aims to further define the drug’s clinical profile and its potential to address corneal damage associated with the disease.
With patient dosing now underway, TearSolutions is entering a critical stage in its development program. Results from this trial will help determine next steps for Lacripep as the company works toward delivering a new treatment option for patients affected by this rare and sight-threatening condition.
