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Wize Pharma Announces Positive Results in First Controlled Study of Treatment for Dry Eye Syndrome in Patients With Conjunctivochalasis
HOD HASHARON, Israel, April 29, 2019 /PRNewswire/ -- Wize Pharma, Inc. (OTCQB: WIZP) a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, today 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 Company believes this result to be very important.
"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.," stated 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.
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.
About Dry Eye Syndrome (DES) and Conjunctivochalasis (CCh)
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.
Wize Pharma, Inc. is a clinical-stage biopharmaceutical company currently focused on the treatment of ophthalmic disorders, including DES. Wize has in-licensed certain rights to purchase, market, sell and distribute a formula known as LO2A, a drug developed for the treatment of DES, and other ophthalmological illnesses, including CCh and Sjögren's syndrome (Sjögren's).
LO2A is currently registered and marketed by its inventor in Germany and Switzerland for the treatment of DES, in Hungary for the treatment of DES, CCH and Sjögren's and in the Netherlands for the treatment of DES and Sjögren's. Wize's strategy involves engaging local or multinational distributors to handle the distribution of LO2A. Wize has finished a Phase II trial of LO2A for patients with CCH and is currently conducting a Phase IV study for LO2A for DES in patients with Sjögren's.
Forward Looking Statements
Wize cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as "expect," "intend," "plan," "anticipate," "believe," and "will," among others. For example, when we discuss our market potential, we are using a forward-looking statement. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Wize's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the possibility that we will not be able to successfully operate our joint venture with Cannabics Pharmaceuticals, Inc.; risks related to the substantial debt that we have incurred; our needs for additional financing; our dependence on a single compound, LO2A and on the continuation of our license to commercialize LO2A; our inability to expand our rights under our license of LO2A; the initiation, timing, progress and results of our trials and product candidate development efforts; our ability to advance LO2A into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for LO2A, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of LO2A; our ability to establish and maintain corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering LO2A and our ability to operate our business without infringing the intellectual property rights of others; estimates of our expenses, future revenues, and capital requirements; competitive companies, technologies and our industry; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting Wize is contained under the heading "Risk Factors" included in Wize's Annual Report on Form 10-K filed with the SEC on April 1, 2019, and in other filings that Wize has made and may make with the SEC in the future. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Wize does not undertake any obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
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