TearSolutions, Inc., Announces Results From First-In-Human Clinical Trial published in Cornea

TearSolutions, Inc., Announces Results From First-In-Human Clinical Trial published in Cornea Charlottesville, Va. – Sept. 28, 2022 – TearSolutions, Inc., a privately held developer of a potentially disruptive therapy for the treatment of Dry Eye Disease (DED) called LacripepTM, today announced that the results from its first-in-human study have been published in Cornea, a leading peer-reviewed ophthalmology journal. This study, the largest ophthalmic trial to date in patients with primary Sjögren's syndrome DED, established Lacripep’s safety and tolerability as well as its ability to significantly improve clinically relevant signs and symptoms of DED. Patients in the study experienced improvements after just two weeks of treatment, which is market-leading in terms of Lacripep’s speed of efficacy and relief. The study also established Lacripep’s safety, tolerability and metrics of efficacy in patients with moderate to severe DED. “We are thrilled that Cornea published our first-in-human study, as it validates our belief that Lacripep represents a novel and potentially transformative solution in a market that continues to have significant unmet needs," said TearSolutions President and CEO Anil Asrani. "We look forward to building upon this data as we now move into our next clinical trial where we will test whether we can deliver even faster and better relief for patients suffering from this disease without sacrificing our best-in-class comfort profile." TearSolutions will leverage the learnings from this trial to inform a Phase II clinical trial to evaluate the safety and efficacy of Lacripep in the general DED population. "Our goal is to provide a solution for all patients who suffer from Dry Eye Disease, as we know that all forms of DED are deficient in ‘Lacritin,’ our proprietary protein, from which TearSolutions’ therapeutic peptides like Lacripep are derived and serve as natural replacement therapies," Asrani said. About TearSolutions, Inc. TearSolutions is a privately held biotechnology company focused on the discovery, development and commercialization of novel therapies for the treatment of patients with DED. The Company is based in Charlottesville, VA. The Company is currently developing Lacripep, a bioactive proprietary proteoform of lacritin, for chronic treatment of the signs and symptoms of DED and recently completed a Phase I/II clinical trial of Lacripep in primary Sjögren’s Syndrome (pSS) patients, who experience the most severe form of DED. This trial represents the largest ophthalmic trial undertaken to date in the pSS patient population and is the first clinical study conducted with Lacripep as the active ingredient. Lacripep exhibited a highly statistically significant reduction in sign (inferior corneal staining) and symptom (burning and stinging). Importantly, it showed this improvement after only two weeks of dosing. Lacripep was well tolerated in this population and no serious treatment related adverse events were observed. TearSolutions continues to focus on the development of additional product candidates for DED. More information is available at www.tearsolutions.com About Lacripep Lacripep was patented by Dr. Gordon Laurie, a professor at the University of Virginia, based on his groundbreaking NIH funded research into the biological basis of DED. He discovered lacritin and developed Lacripep, which represents a unique treatment modality, since it would be a naturally occurring protein replacement therapy to restore homeostasis in patients with DED, as well as representing a novel mechanism of action in DED. The intellectual property invented by Dr. Laurie is exclusively licensed to TearSolutions, Inc. from the University of Virginia Licensing and Ventures Group. Investors & Media Anil Asrani, Chief Executive Officer, TearSolutions [email protected] Colin Rolph, Chief Financial Officer, TearSolutions [email protected] Source: TearSolutions, Inc.

The release as fetched from its publisher. tearsolutions.com ↗