Wize Pharma sought IRB approval for Phase IV study
Clinical-stage biopharmaceutical company,Wize Pharma aiming to undertake treatment of opthalmic disorders asserted having received Institutional Review Board approval for the protocol of its Phase IV study. Phase IV randomized, double-blind, placebo-controlled study of LO2A versus Alcon’s Systane Ultra UD, an over-the-counter lubricant eye drop product used to relieve dry and irritated eyes.
The study set to assess he safety and efficacy of LO2A for symptomatic improvement of DES in 60 adult patients with Sjögren’s. Enrolled patients will be randomized in a 1:1 ratio to one of two treatment groups, LO2A or Systane Ultra UD.
The study is designed to advocate Wize’s clinical approval pathway for LO2A for treatment of DES in Sjögren’s patients within certain markets including the U.S, China, Ukraine and Israel. Enrolling commences in the first quarter of 2018. LO2A currently has regulatory approval for DES in Israel, where sales are anticipated to begin for Wize in 2018. 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.
Wize’s Chairman, Ron Mayron stated “IRB approval marks an important milestone in our clinical development program of LO2A for the treatment of DES in Sjögren’s patients. LO2A has previously demonstrated efficacy in providing symptomatic improvement of dry eye associated with Sjögren’s in a clinical trial in Hungary and has been approved for this indication in the Netherlands. We look forward to commencing our Phase IV study, aiming to advance towards regulatory approvals for treatment of patients suffering from DES and Sjögren’s in multiple markets where the formula is not yet available including eventually the United States,”
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 afflict up to 4 million people in the U.S. 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.