Wize Pharma Completes Phase IV Study of LO2A for Dry Eye Syndrome with Sjögren's Syndrome

Wize Pharma 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," said 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.

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