TearSolutions, Inc. (“TearSolutions”), a clinical-stage biotechnology company developing novel ophthalmic therapeutics, today announced receiving Food and Drug Administration (FDA) Orphan Drug (ODD) and Fast Track Designations for Lacripep in Neurotrophic Keratitis (NK) and initiating a Phase 2 clinical trial with first patients dosed.
The FDA’s ODD provides incentives, including tax credits for clinical testing and up to seven years of U.S. market exclusivity upon regulatory approval. The Fast Track Designation facilitates more frequent interactions with the FDA and enables a rolling review of the New Drug Application, expediting the development and review process for drugs that treat serious conditions.
NK is a rare, degenerative corneal disease characterized by a reduction or absence of corneal sensitivity and severe impairment of corneal healing, which can lead to persistent epithelial defects and vision loss.
“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
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