LO2A Licensor, Resdevco, Granted Market Approval for the Treatment of Sjögren's Syndrome in Hungary
HOD HASHARON, Israel, March 11, 2019 /PRNewswire/ -- Wize Pharma, Inc. ("Wize Pharma" or the "Company") (OTCQB: WIZP) a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, today announced that it was informed by Resdevco, LO2A licensor, that its Hungarian distributor has received an updated market authorization from the Hungarian regulatory authority, The National Institute of Pharmacy and Nutrition (OGYÉI) for the treatment of ophthalmological symptoms of Sjögren's Syndrome. As a result, LO2A, marketed under the trade name Conheal® in Hungary, is now available for the treatment of dry eye syndrome, Conjunctivochalasis and ophthalmological symptoms of Sjögren's Syndrome.
LO2A is already approved in The Netherlands for the treatment of dry eye syndrome and protection from dry eye as result of Sjögren's Syndrome. Both countries are member states of the European Union.
"There are limited therapeutics options for the treatment of the eye problems resulting from Sjogren's syndrome, all of them used off label and without specific regulatory authorization. Consequently, this approval is an important event in the development plan for LO2A, being the first eyedrops specifically approved for treatment of the ophthalmological symptoms of Sjögren's Syndrome. Most patients use products intended to treat dry eye to manage this much more severe condition," said Wize's Chairman, Noam Danenberg. "Wize Pharma's clinical program focuses on pursuing LO2A approval for treatment of ophthalmological symptoms of Sjögren's Syndrome and treatment of Conjunctivochalasis in the United States. The European regulatory approvals will provide further supportive data for clinical and regulatory development in the USA."
Sjogren's syndrome is an autoimmune disease that attacks the glands that make tears and saliva. This causes a dry mouth, dry eyes and potentially dryness in other places such as the nose, throat and skin.
About Wize Pharma, Inc.
Wize Pharma, Inc. is a clinical-stage biopharmaceutical company currently focused on the treatment of ophthalmic disorders, including dry eye syndrome ("DES"). Wize Pharma 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 conjunctivochalasis ("CCH") and ophthalmological symptoms of Sjögren's Syndrome. Wize Pharma 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 Syndrome. 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 ophthalmological symptoms of Sjögren's Syndrome and in the Netherlands for the treatment of DES and protection from dry eye as result of Sjögren's Syndrome. Wize Pharma's strategy involves engaging local or multinational distributors to handle the distribution of LO2A.
Forward Looking Statements
Wize Pharma 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. 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 Pharma'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 the joint venture agreement may never become effective or will be terminated if the Company and Cannabics do not agree on a business plan for the joint venture, changes in government policy and/or regulation, 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 Pharma is contained under the heading "Risk Factors" included in Wize Pharma's Annual Report on Form 10-K filed with the SEC on March 29, 2018, and in other filings that Wize Pharma 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 Pharma 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 whether as a result of new information, future events or otherwise, except as may be required by law.
For all Inquiries, please contact:
CFO & Acting CEO
LHA Investor Relations
Miriam Weber Miller
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SOURCE Wize Pharma, Inc.