Results from the trial are expected later this year, though they may be delayed due to the ongoing COVID-19 pandemic. If positive, the results are expected to support an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA), as well as other regulatory agencies elsewhere in the world.
“Having completed the study, we now look forward to evaluating the data resulting from this Phase IV trial in Sjogren’s,” Noam Danenberg, CEO of Wize, said in a press release. “We believe that positive results in this current study … will create a strong application package for an IND with the [FDA].
In Sjögren’s syndrome the body’s immune system attacks the tear ducts and salivary glands. As such, dry eyes — as a result of insufficient tear production — is a common symptom that can reduce quality of life and lead to damage to the eyes themselves.
LO2A eye drops were developed as a replacement for natural tears, to moisten and protect the eyes. The drops can be used with contact lenses and they come in single-dose vials to minimize risk of infection or contamination.
About 60 people with Sjögren’s syndrome who were experiencing dry eyes were enrolled in the trial and assigned randomly to treatment with one of the two eye drops, applied four times per day in each eye, for three months.
The study’s main efficacy measurement are changes in participants’ scores on the National Eye Institute/Industry Grading System, a measurement of how eyes are damaged by dryness. Other measurements include the the Ocular Surface Disease Index questionnaire, which measures eye health, and Schirmer’s test, which measures tear production. Quality of life also is assessed.
“We previously expected to announce topline results [from the trial] in the second quarter of this year. Due to the impact of COVID-19 on the healthcare 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,” Danenberg said.
LO2A eye drops are currently approved for treating dry eye symptoms in people with Sjögren’s syndrome in Hungary, where they are marketed as Conheal by Resdevco, and in the Netherlands, where the drops are marketed as Hylan by Pharma Stulln. The drops also have been available to people with dry eye syndrome in Israel and several European countries for more than a decade.
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