Wize Pharma announced completion of statistical analysis of the Phase II clinical results from its trial of LO2A for the symptomatic treatment of dry eye syndrome (DES) in patients with moderate to severe conjunctivochalasis (CCh). LO2A is a prescription eye drop for the treatment of DES, as well as DES in patients with CCh and Sjögren's Syndrome.
Achieving its primary efficacy endpoint, LO2A diminished the objective parameters of the corneal damage of CCh patients.
"The full statistical analysis of our Phase II study results confirms LO2A's efficacy in treating DES in patients with CCh. Multiple clinical measures, most notably the primary efficacy endpoint, suggest that LO2A is effective in this patient population. We intend to use this data in a pre-IND meeting with the FDA, when we will seek guidance on the regulatory approval path in the U.S.," said Wize's CEO, Noam Danenberg. "With LO2A we are addressing a multi-billion dollar market with a prescription grade eye drop that has distinct advantages over the standard of care, including the fact that LO2A can be used with any contact lenses and that it is preservative free, thereby minimizing the potential for corneal damage. Moreover, LO2A is the first and only treatment to be evaluated in the treatment of DES in patients with CCh, and therefore is positioned to potentially become the first such product on the market, given regulatory approval."
CCh refers to the presence of redundant folds of loose conjunctiva. These folds can irritate the eye and disrupt the tear film and its outflow, leading to DES. CCh is thought to be present in up to one-third of patients with DES. The global DES treatment market was valued at approximately $3.7 billion in 2017 and is expected to grow to $4.9 billion by 2022 according to Market Scope.
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The Phase II multi-center, randomized, double-blind, placebo-controlled study demonstrated the efficacy to treat the dry eye and safety of LO2A as compared to placebo in patients with moderate to severe CCh. Patients were randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, and were treated with topical eye drops for three months.
The primary endpoint was a change from baseline in lissamine green conjunctival staining (LGCS) score, a standard measurement tool for this indication, at three months. The originally planned primary analysis was based upon recruitment of a sample size of 62 patients. The actual analysis, performed on the 49 fully-evaluable patients, used a mixed model with repeated measures (MMRM) and utilized all post baseline observations (1-month and 3-month follow-ups). This measure demonstrated a statistically significant improvement in the LO2A-treated group compared to the placebo group (P=0.0079).
The original planned primary endpoint analysis, which compared average reduction in LGCS score from baseline to three months, demonstrated a strong trend towards significance (P=0.0713). Average reduction in LGCS scores between baseline and 3 months were -3.5 and -1.6 in the LO2A and placebo groups, respectively.
While the study was not powered to demonstrate statistically significant differences in the secondary endpoints, the results indicated the probability of significant improvement with a larger sample size.
LO2A treatment was shown to be safe and well tolerated in this Phase II study in terms of adverse events, visual acuity, slit lamp examination, fundoscopy or intraocular pressure.
DES is caused by the reduced production and/or improper quality of tear film. CCh is present in up to one-third of dry eye patients. CCh refers to the presence of redundant folds of loose conjunctiva. These folds can irritate the eye and disrupt tear film and its outflow, leading to DES.