SEP 08, 2014
Comprehensive Ophthalmology, Cornea/External Disease
Herantis Pharma announced that the U.S. FDA has cleared its Investigational New Drug application for a phase 2 study of Cis-UCA, an eye drop targeting the inflammation that causes dry eye symptoms.
The company expects to begin patient enrollment in 2014 for a multicenter study of 150 patients randomized to receive either placebo or one of two different doses of Cis-UCA.
Cis-urocanic acid (cis-UCA), is an endogenous small molecule component of human and animal skin shown to suppress the inflammatory response in ocular epithelial cells, and has shown a strong cytoprotective effect on the ocular epithelial cells, reversing the loss of cell viability in response to the UVB stress.
Preclinical studies in relevant animal models of eye inflammation also demonstrate strong proof-of-concept for the cis-UCA eye drops.