TearSolutions Announces Results From First-In-Human Clinical Trial Published in Cornea

TearSolutions announced that the results from its first-in-human study of Lacripep for the treatment of dry eye disease have been published in Cornea.

The 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, according to TearSolutions. Patients in the study experienced improvements after just 2 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," TearSolutions President and CEO Anil Asrani said in a company news release. "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 2 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," Mr. Asrani said.