Major Drugs - Charlottesville, VA, US
TearSolutions Inc. is a Delaware Corporation based in Charlottesville, VA. The company has successfully completed a well-powered 204 patient Phase II Proof of Concept clinical trial for the treatment of the signs and symptoms of dry eye in primary Sjögren's Syndrome patients. Statistically significant improvement in both sign and symptom at two weeks was found. The trial compared vehicle and two doses of LacripepTM, a novel 19 AA peptide that is present in normal tears and deficient in all forms of dry eye. The peptide restores homeostasis to the ocular surface, in particular the barrier function of the corneal epithelium and normal function of sensory nerves at the corneal surface in preclinical animal models. Restoration of epithelial barrier function can be measured clinically as a decrease in corneal fluorescein staining while the improvement in sensory nerve function restores normal production of the components of tears: the aqueous via reinnervation of lacrimal glands, the lipid via reinnervation of meibomium glands and the mucin via reinnervation of goblet cells. Improvement in fluorescein staining and tear production (Schirmer tear test) are clinical ‘signs' of dry eye that have been used in the FDA approval of Xiidra and Restasis respectively.LacripepTM was discovered at the University of Virginia with NEI funding as a naturally occurring fragment of the larger 119 AA protein, lacritin, in an unbiased screen for novel factors capable of addressing dry eye.Management team- CEO/President: Anil Asrani- Executive Chairman/Cofounder: Mark B. Logan- CSO/Cofounder: Gordon W. Laurie PhD, FARVO- CFO: Colin M. Rolph- Chief Regulatory Officer: Michelle Carpenter JD, RAC- Chief Medical Officer: Marc G. Odrich, MD- Secretary: Mac Thompson, LLDAdvisory Board- Manus C. Kraff MD- Jae K. Lee PhD- J. Daniel Nelson MD, FACS, FARVO- Kazuo Tsubota MD, FARVO
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