Wize Pharma Completes Phase IV Study of LO2A for the Treatment of Dry Eye Syndrome in Patients with Sjögren's Syndrome
HOD HASHARON, Israel, May 7, 2020 /PRNewswire/ -- Wize Pharma, Inc. (OTCQB: WIZP), a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, today announced it has completed treating patients in its Phase IV clinical trial of its prescription eye drop formula, LO2A, for the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren's syndrome.
This study is designed to demonstrate the clinical efficacy and safety of LO2A in DES patients with Sjögren's syndrome. Since LO2A has been previously approved for marketing in Israel for DES patients, the Israeli Ministry of Health classified the study as a post-marketing Phase IV study for the purpose of expanding LO2A's current approved status for the treatment of DES to include the symptomatic treatment of DES in patients with Sjögren's syndrome.
"Having completed the study, we now look forward to evaluating the data resulting from this Phase IV trial in Sjogren's. We believe that positive results in this current study, when combined with the positive results from our Phase II conjunctivochalasis (CCh) study, will create a strong application package for an IND with the U.S. Food and Drug Administration," stated Noam Danenberg, CEO of Wize. "We previously expected to announce topline results in the second quarter of this year. Due to the impact of COVID-19 on the healthcare system and our current limited ability to access hospitals to monitor data, the release of topline results may potentially be delayed into the third fiscal quarter of 2020."
More than 16 million adults have DES in the U.S., where the treatment market was valued at $4.5 billion in 2018 and is expected to grow to $6.2 billion in 2024. Growth in DES is driven by an aging population, increased screen usage, exposure to air conditioning and weather conditions, leading to an economic burden to U.S. economy of $55.4 billion.
The Phase IV trial is a randomized, double-masked study intended to evaluate LO2A versus Alcon's Systane® Ultra UD, an over-the-counter lubricant eye drop product used to relieve dry and irritated eyes. Approximately 60 evaluable patients with Sjögren's syndrome experiencing DES were randomized in a 1:1 ratio to one of two treatment groups, LO2A or Systane® Ultra UD. Drops were administered topically to the eye over a three-month period. The primary endpoint of the study is change in corneal/conjunctival staining score using the National Eye Institute (NEI) Industry Grading System after 3 months of study treatment. This is an objective measure used to determine the severity of the damage caused by dryness of the eye. Secondary endpoints include corneal/conjunctival staining score after one month of treatment and change in quality of life with subjective questionnaires such as Ocular Surface Disease Index (OSDI) and Visual Analogue Scale (VAS) score after one and three months of treatment.
LO2A is approved for the symptomatic treatment of DES in patients with Sjögren's syndrome in the Netherlands and Hungary.
About Wize Pharma
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. In November 2018, Wize completed a Phase II randomized, double-blind, placebo-controlled trial of LO2A for patients with CCh, which demonstrated a statistical significance result, using a mixed model with repeated measures (MMRM). Wize is currently conducting a Phase IV study for LO2A for DES in patients with Sjögren's, expected to publish results in either the second or third fiscal quarter of 2020.
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 that the study is designed to demonstrate the clinical efficacy of LO2A in DES patients with Sjögren's syndrome, the expected timing of the release of topline data from the Phase IV trial, and our belief that the data resulting from the Phase IV trial, combined with the with the positive results from our Phase II CCh study, will create a strong application package for an IND with the U.S. Food and Drug Administration, 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 consummate the transactions with Bonus and the investors or, if we do consummate such transactions, that we will not receive the benefits we planned to achieve from such transactions; the possibility that we will not be able to successfully operate our joint venture with Cannabics Pharmaceuticals, Inc.; 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 Securities and Exchange Commission (the "SEC") on March 30, 2020, 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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