LO2A studied for Sjögren-related dry eye symptoms
A phase 4 study set in Israel of a potential treatment for dry eye symptoms related to Sjögren’s syndrome has concluded, Wize Pharma announced in a press release.
LO2A, which is marketed in Israel for dry eye syndrome, was tested against Alcon’s Systane Ultra UD (propylene glycol) over-the-counter product in a randomized, double-masked study evaluating about 60 patients with Sjögren’s syndrome and related dry eye symptoms.
Patients were split into two groups and monitored over a 3-month period. Primary endpoint was change in corneal and conjunctival staining score.
"Having completed the study, we now look forward to evaluating the data resulting from this phase 4 trial in Sjogren's. We believe that positive results in this current study, when combined with the positive results from our phase 2 conjunctivochalasis (CCh) study, will create a strong application package for an IND with the U.S. Food and Drug Administration," Wize CEO Noam Danenberg said. "We previously expected to announce topline results in the second quarter of this year. Due to the impact of COVID-19 on the health care 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."
LO2A is approved in the Netherlands and Hungary for treatment of dry eye syndrome in patients with Sjögren's syndrome.