|Posted by australiandryeye on June 17, 2018 at 5:55 AM|
LO2A eye drops significantly improve dry eye symptoms in Sjögren’s syndrome patients, according to a small Phase 2 clinical study performed in Hungary.
The findings were presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, on May 2 in Honolulu, Hawaii, in the poster presentation “The anti-inflammatory effect of isotonic glycerol in Sjögren’s syndrome-related dry eye.”
The reduced tear production associated with Sjögren’s syndrome leads to eye dryness, one of the hallmarks of this autoimmune disease. Patients experience a persistent dry, scratchy feeling in the eyes that can lead to damage and a decrease in quality of life.
LO2A eye drops — known as Conheal in Hungary — are artificial tears presented in unit-dose vials that contain isotonic glycerol and hyaluronic acid. The formulation is registered and marketed by its inventor for the treatment of dry eye syndrome in Hungary, Germany, Switzerland, Israel, and Netherlands, and for Sjögren’s syndrome in the Netherlands.
Wize Pharma, an Israel-based company that has in-licensed certain rights to purchase, market, sell and distribute LO2A in some countries, is seeking clinical approval of LO2A for the treatment of dry eye disease in Sjogren’s patients in Israel, the U.S., China, and Ukraine.
A small Phase 2 trial (ISRCTN17717813) evaluated the effectiveness of LO2A eye drops in patients with Sjögren’s dry eye symptoms. The study was led by Huba Kiss, MD, at the Department of Ophthalmology, Semmelweis University, in Budapest, Hungary.
The study involved 21 adult Sjögren’s patients, who received the artifical tear drops four times a day for three months. Participants were followed up at one and three months with ophthalmologic tests, and symptoms were assessed using the Ocular Surface Disease Index (OSDI) questionnaire.
After three months, both ophthalmologic tests and OSDI scores showed significant improvements in dry eye disease, according to a Wize Pharma press release. Importantly, the company noted, the clinical benefits of LO2A eye drops in this study were achieved without the need for anti-inflammatory drugs.
Previous lab experiments suggested that the positive effect of LO2A eye drops may be related to its isotonic glycerol component, which may decrease the levels of HLA-DR (cell surface molecules associated with Sjögren’s syndrome).
“This data supports our development efforts for LO2A in multiple markets including Israel where we are currently enrolling patients in a randomized, double-masked Phase IV study in this indication [Sjögren’s syndrome-related dry eye disease],” said Ron Mayron, Wize Pharma’s chairman.
Wize’s randomized, double-blind, Phase 4 clinical trial (NCT03319420) received regulatory approval to begin earlier this year, and will evaluate the safety and effectiveness of LO2A eye drops to improve dry eye symptoms in 60 adult Sjögren’s patients.
Participants will be assigned randomly to receive either LO2A eye drops or Alcon’s Systane Ultra UD over-the-counter lubricant eye drops four times a day for three months.
The study’s goals include improvements in corneal/conjunctival staining score, and OSDI score after one and three months. The trial is due to end by February 2019.