TearSolutions planning Phase II/III trials for therapy to treat dry eye disease

TearSolutions Inc. 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.

Late last year, the company received the minutes from a Type C meeting with the FDA regarding the development of Lacripep for the treatment of keratoconjunctivitis sicca, also known as DED, which initiated its plans to start one of two phase III trials.

According to the company, 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 company noted that 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 said in a release that it is currently planning the first phase III with targeted first enrollment in July, for which the company would expect top-line efficacy results from the general DED study in the first quarter of 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,” Marc Odrich, chief medical officer for the company, said in a statement. “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.”