Wize Pharma Announces Positive Topline Results in Phase IV Study of LO2A for the Treatment of Dry Eye Syndrome in Patients with Sjögren's Syndrome
- LO2A successfully demonstrated non-inferiority vs comparator on all efficacy endpoints treating dry eye signs and symptoms in patients suffering from Sjögren's syndrome
- LO2A continues to demonstrate a safe treatment profile
- Results demonstrated clinically meaningful improvement in both signs and symptoms in line with U.S. FDA ophthalmic drug approval expectations
- Exploratory analysis resulted in additional positive observations with regards to LO2A's potential clinical attributes
Nov 12, 2020, 08:58 ET
HOD HASHARON, Israel, Nov. 12, 2020 /PRNewswire/ -- Wize Pharma, Inc. (OTCQB: WIZP), a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, today reported topline results from its Phase IV clinical trial of its in-license eye drop formula, LO2A, for the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren's syndrome.
The randomized, double-masked comparative study evaluated LO2A versus Alcon's Systane® Ultra UD ("comparator"), an over-the-counter lubricant eye drop product used to relieve dry and irritated eyes in DES patients, which is also used to treat dry eye in patients with Sjögren's syndrome.
The study was performed in five centers in Israel and was classified as a Phase IV exploratory study, since LO2A is already approved for marketing in Israel for DES patients.
The study design included 69 patients (138 eyes) with Sjögren's syndrome experiencing DES that were randomized in a 1:1 ratio into two treatment groups, LO2A or Systane® Ultra UD. Drops were administered topically to the eye over a 3-month period.
The primary endpoint of the study was change in corneal 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 (referred to as "sign").
Secondary endpoints included a conjunctival staining score after one month of treatment and changes in quality of life with subjective questionnaires, including Ocular Surface Disease Index (OSDI) and Visual Analogue Scale (VAS) score after one and three months of treatment (referred to as "symptoms").
Clinically significant results were defined as a reduction of 3 points in corneal and conjunctival staining and an improvement of 30 points in VAS and of 10 points in OSDI measurements.
Topline results include:
- LOA2 met its primary endpoint of non-inferiority vs. comparator at the 3-month time point in corneal staining with a p value of 0.001.
- LO2A continued, as in prior trials, to demonstrate a good safety profile with no major adverse events or side effects reported.
- A numeric advantage was evident in both the signs and symptoms of DES for patients using LO2A vs. the comparator in the subgroup of patients with primary Sjögren's (11 and 17 patients with primary Sjögren's were in the LO2A and Control groups, respectively).
- LO2A demonstrated clinically meaningful improvement in both the signs and symptoms of DES in patients suffering from Sjögren's - 100% of the patients treated with LO2A showed a clinically significant improvement in at least one of the primary and secondary end point measurements included in the trial at the 3-month time point vs. 90% of patients treated with comparator. In addition, among the LO2A treatment group, 74% of patients showed a clinically significant improvement in both signs and symptoms vs. 59% in the comparator group.
- For the subset of patients with primary Sjögren's, average conjunctival staining at the 3-month time point was reduced on average by 4.1 points by LO2A, compared to an average reduction of 2.7 points by the comparator, marking about a 52% difference.
- For the subset of patients with primary Sjögren's, there was an average reduction of 37.4 points in the eye dryness score measured by VAS in the group treated by LO2A, compared to an average reduction of 21.4 points in the comparator group at the 3-month time point, resulting in approximately a 75% difference.
"We are pleased with these topline results, especially given the clinical improvement in signs and symptoms. Sjögren's patients that are suffering from dry eye tend to develop severe dry eye, and we believe LO2A has clearly demonstrated its ability to improve both signs and symptoms of these patients. LO2A appears to be a promising proposition to this sub-group of patients and in-line with the growing need for personalized treatment. Sjögren's patients suffering from dry eye currently have no approved treatment available and this data supports our plans to monetize our rights in the LO2A technology," stated Noam Danenberg, CEO of Wize.
Dr. Penny Asbell, MD, Chair of the Department of Ophthalmology at The University of Tennessee Health Science Center and Director of the Hamilton Eye Institute commented, "Dry eyes are typically one of the most bothersome symptoms associated with Sjögren's syndrome. This subpopulation of dry eye is often especially bothered by ocular discomfort, blurred vision, and visual fatigue affecting their quality of life, and with little specific treatment to address their symptoms. The LO2A clinical trial is an important step in finding new treatments for dry eye associated with Sjögren's."
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.
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 data resulting from the Phase IV trial supports our plans to monetize our rights in the LO2A technology that we believe LO2A has clearly demonstrated its ability to improve both signs and symptoms in Sjögren's patients suffering from DES, and that LO2A appears to be a promising proposition to Sjögren's patients suffering from DES and is in-line with the growing need for personalized treatment, 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, 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 applicable law.
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