Phase 4 Trial of Treatment for Dry Eyes, LO2A Drops, in Sjögren’s Patients Fully Enrolled

A Phase 4 clinical trial investigating LO2A eye drops, by Wize Pharma, as a treatment for dry eye symptoms in Sjögren’s syndrome patients is fully enrolled, the company announced.

Topline results from the study, taking place at multiple sites in Israel, are expected by August. They will be used to support requests for the eye drop formula’s approval to treat Sjögren’s in that and other countries, including the U.S. and China.

“We are very pleased to have completed enrollment in this Phase 4 study,” Noam Danenberg, the CEO of Wize, said in a press release.

LO2A is currently approved to treat dry eyes due to Sjögren’s syndrome in Hungary and the Netherlands, Danenberg added.

Insufficient tear production is a hallmark of this autoimmune disease, the result of damaging immune system attacks that target glands producing tears and saliva. Patients experience a persistently dry, scratchy feeling in the eyes that can be damaging and that affect their quality of life.

Wize developed LO2A as a substitute for the tears that lubricate and protect the surface of the eyes. It can be used with contact lenses.

The treatment has been available to people with dry eye syndrome in Israel and several European countries for more than 10 years. Hungary and the Netherlands recently extended its approval to cover dry eye symptoms caused by Sjögren’s syndrome.

LO2A eye drops are marketed as Conheal, by Resdevco, in Hungrary and as Hylan, by Pharma Stulln, in the Netherlands. They come in single dose vials to minimize risk of infection and contamination, Wize reports.

The ongoing Phase 4 trial (NCT03319420), also known as a post-marketing surveillance study, is comparing LO2A’s ability to relieve dry eyes with that of an over-the-counter lubricant known as Systane Ultra UD. About 60 people with Sjögren’s will use the drops, four times daily in each eye, for three months.

Its primary goal is to see if LO2A lessens the damage done to the eyes by dryness, as measured through changes in patients’ scores on the National Eye Institute/Industry (NEI) Industry Grading System from the study’s start to the end of treatment.

Secondary goals include improvements in eye health and in tear production, assessed through changes in the Ocular Surface Disease Index (OSDI) questionnaire and Schirmer’s test scores, respectively.