Wize Pharma Completes Patient Enrollment In Phase IV Study Of LO2A for the Treatment of Dry Eye Syndrome in Patients With Sjögren's Syndrome

Hod Hasharon: Wize Pharma a clinical-stage biopharmaceutical company focused on the treatment of ophthalmic disorders, today announced it has completed enrolment in its Phase IV clinical trial of its eye drop formula to evaluate the efficacy of LO2A for the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren's syndrome.

"We are very pleased to have completed enrolment in this Phase IV study. We expect to announce topline results during the second quarter of this year," stated Wize CEO Noam Danenberg. "LO2A is already approved for the symptomatic treatment of DES in patients with Sjögren's syndrome in Hungary and the Netherlands."

LO2A is approved for marketing in Israel under the tradename EyeCon®. Although it is not yet approved for the symptomatic treatment of DES in patients with Sjögren's syndrome in Israel, this study was classified as a post-marketing, Phase IV study by the Israeli Ministry of Health. The Phase IV trial is a randomized, double-masked study 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 who are experiencing DES are being randomized in a 1:1 ratio to one of two treatment groups, LO2A or Systane® Ultra UD. Drops are administered topically to the eye over a three-month period. The primary endpoint of the study changes 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 Ocular Surface Disease Index (OSDI) score after one and three months of treatment.

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This study is designed to support Wize's clinical approval pathway for LO2A for the treatment of DES in patients with Sjögren's syndrome in the USA and other markets.

Following successful completion of the Phase IV study in Sjögren's syndrome, Wize plans to submit data from both this Phase IV study and the formerly announced completed Phase II CCh study to the U.S Food and Drug Administration through a pre-Investigational New Drug (IND) meeting, where Wize will seek guidance on the regulatory approval path for LO2A in the U.S.

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