TearSolutions, Inc. Announces Outcome of Type C Meeting with FDA and Next Steps in the Development of Lacripep™
Charlottesville, Va., Feb. 14, 2022 — TearSolutions, Inc. (“the Company”), a privately held developer of a replacement therapy for the treatment of Dry Eye Disease (DED) called Lacripep, today announced that in late 2021 it received official minutes from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the development of Lacripep for the treatment of keratoconjunctivitis sicca, also known as DED, and is planning to begin one of two phase III trials.
Based on guidance the Company received, TearSolutions is preparing to conduct two phase III pivotal trials, one in a primary Sjögren’s Syndrome (pSS) patient population and the second in a potentially less severe general dry eye population. The first trial will be a multi-part Phase II/III trial where one study will be conducted in patients with DED associated with pSS to confirm results observed in the previously conducted Phase I/II trial and the other study will be in a general, potentially less severe, DED population. The second phase III trial is planned to be in a general DED population that will not exclude pSS patients. In addition, FDA provided guidance with regard to the study design for the first phase III, which has been incorporated into the trials’ preliminary design characteristics:
- Number of patients: approximately 240
- Patient populations: pSS associated DED and general DED
- Primary endpoint: statistically significant improvement in both sign (inferior corneal fluorescein staining) and symptom (burning and stinging) as compared to baseline
- Visits: Screening/Baseline, Week 2, Week 4, Week 6 and safety follow-up over the course of one year
The Company is currently planning the first phase III with targeted first enrollment in July 2022, for which the Company would expect top-line efficacy results from the general DED study in Q1 2023 and at the end of 2023 for the pSS DED study. The initiation and execution of the first phase III, beyond the start-up phase, is subject to additional funding or strategic partnering and may be further impacted by the COVID-19 pandemic.
“We thank FDA for the constructive comments, guidance and support related to the continued development of Lacripep,” commented Marc Odrich, Chief Medical Officer. “The feedback from FDA and our advisors, along with the learnings from our Phase I/II first-in-human trial has us convinced that we are on a path to bringing a novel and disruptive therapy to the market in Lacripep, which has the potential to address significant unmet needs for the millions of people suffering from Dry Eye Disease.”
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
Lacripep was patented by Dr. Gordon Laurie, a professor at the University of Virginia, based on his groundbreaking NIH funded research into the composition of human tears. 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.