Wize Pharma, Inc. a clinical-stage biopharmaceutical company, has enrolled the first patient in its phase IV clinical trial in Israel for LO2A in the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren's syndrome.

In addition to meeting marketing approval requirements in Israel, this study is also designed to support Wize's clinical approval pathway for LO2A for the treatment of DES in patients with Sjögren's in other markets including the US, China, and Ukraine. LO2A is already approved in Israel for the treatment of DES and sales are expected to commence in Israel in 2018.

This randomized, double-masked study will 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 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 will be 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 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.

"We are very pleased to commence patient enrollment in this phase IV study and we expect the study to complete enrollment and treatment of all patients in the fourth quarter of 2018. If the study meets its primary endpoint, we expect this will lead to approval from the Israeli Ministry of Health, which has already approved LO2A for the treatment of DES," stated Wize's Chairman, Ron Mayron. "We are particularly encouraged in this indication because a prior clinical study of LO2A in Hungary demonstrated efficacy in the symptomatic treatment of DES in Sjögren's syndrome patients, which led to LO2A's approval for Sjögren's in the Netherlands."

The global DES treatment market was valued at approximately $3.7 billion in 2017 and is expected to grow to $4.9 billion by 2022 according to Market Scope.

Dry Eye Syndrome (DES) is caused by the reduced production and/or improper quality of tear film. One of the causes of reduced tear production is Sjögren's, a chronic autoimmune disease that is estimated to affect up to 4 million people in the US. In patients with DES and Sjögren's, the absence of adequate tear production disrupts the normal function of the tear film in protecting the surface of the eye, resulting in increased friction that damages the integrity of the corneal and conjunctival surface.

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 Conjunctivochalasis (CCH) and Sjögren's.