The FDA granted orphan drug designation and fast track designation to Lacripep, according to a press release from TearSolutions. If approved, Lacripep would be the second treatment indicated for neurotrophic keratitis.
In addition, the first patients have been dosed in a phase 2 multicenter, randomized clinical trial of Lacripep, the company said.
The topical therapy is a synthetic peptide made from “a naturally occurring fragment” of lacritin, a human tear protein, according to TearSolutions.
“Lacripep regenerates certain cell types like the corneal epithelium and corneal sensory nerves,”