CHARLOTTESVILLE, Va., Feb. 14 10, 2022 (GLOBE NEWSWIRE) — TearSolutions, Inc. (“the Company”), a private company developing an alternative therapy for the treatment of dry eye disease called Lacripep, today announced that by the end of 2021, it has received official minutes of a Type C meeting with the United States Food and Drug Administration (FDA) regarding the development of Lacripep for the treatment of keratoconjunctivitis sicca, also known as DED, and plans to begin one of two phase III trials.
Based on advice received by the company, TearSolutions is preparing to conduct two pivotal phase III trials, one in a population of patients with primary Sjögren’s syndrome (pSS) and the second in a potentially general dry eye population. less severe. The first trial will be a multi-part phase II/III trial where one study will be conducted in patients with pSS-associated DED to confirm the results seen 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 should focus on a general DED population that will not exclude patients with pSS. In addition, the FDA provided guidance regarding the study design for the first phase III, which was incorporated into the preliminary design features of the trials:
- Number of patients: around 240
- Patient populations: pSS-associated DED and general DED
- Primary endpoint: Statistically significant improvement in both sign (lower fluorescein corneal staining) and symptoms (burning and stinging) from baseline
- Visits: Screening/Baseline, Week 2, Week 4, Week 6 and safety monitoring over the course of a year
The Company is currently planning the first phase III with targeted first recruitment in July 2022, for which the Company expects leading efficacy results from the general DED study in the first quarter of 2023 and the end of 2023 for the pSS DED study. The launch and execution of the first phase III, beyond the start-up phase, is subject to additional funding or strategic partnership and may be further impacted by the COVID-19 pandemic.
“We thank the FDA for the constructive feedback, guidance and support related to the continued development of Lacripep,” commented Marc Odrich, Chief Medical Officer. “Feedback from the FDA and our advisors, as well as learnings from our first-in-man Phase I/II trial, have convinced us that we are on the right track to bringing a new and disruptive therapy to market at Lacripep, which has the potential to address significant unmet needs for the millions of people suffering from dry eye.”
About TearSolutions, Inc.
TearSolutions is a private 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, Virginia. The Company is currently developing Lacripep, a proprietary bioactive proteoform of lacritin, for the chronic treatment of the signs and symptoms of DED and recently completed a Phase I/II clinical trial of Lacripep in patients with primary Sjögren’s syndrome (PSS), who suffer from 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 showed a highly statistically significant reduction in signs (staining of the lower cornea) and symptoms (burning and stinging). Importantly, it showed this improvement after just 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 developing 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 as it is believed to be a natural protein replacement therapy to restore homeostasis in patients with DED, as well as representing a new mechanism for action in the SSO. Intellectual property invented by Dr. Laurie is licensed exclusively to TearSolutions, Inc. of the University of Virginia Licensing and Ventures Group.
Investors & Media
Anil Asrani, Chief Executive Officer, TearSolutions [email protected]
Colin Rolph, CFO, TearSolutions [email protected]
Source: TearSolutions, Inc.