Phase 4 Clinical Trial Completed for Eye Drop Formula for Patients with Sjögren's Syndrome
In the United States, more than 16 million Americans have DES and that number is expected to increase.
A phase 4 clinical trial was recently completed for a prescription eye drop formula (LO2A, Wize Pharma) for symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren's syndrome.
In the United States, more than 16 million Americans have DES and that number is expected to increase. This growth is understood to be driven by an aging population, increased screen usage, exposure to air conditioning, and weather conditions.
The investigational eye drop treatment is not approved by the FDA, but was approved by the Israeli Ministry of Health for DES patients in Israel. In order for the treatment to also be approved in that country for treatment of Sjögren's syndrome, the study was classified by the Israeli Ministry of Health as a post-marketing phase 4 study.
“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 II conjunctivochalasis (CCh) study, will create a strong application package for an IND with the FDA,” said Noam Danenberg, CEO of Wize Pharma, in a press release.
Due to the impact of coronavirus disease 2019 (COVID-19) on the health care system and Wize Pharma’s 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, according to Danenberg.
In order to test the prescription eye drop formula, the study was randomized and double-masked, with 60 patients who have Sjögren's syndrome and DES. The study compared the prescription eye drop formula with an over-the-counter (OTC) lubricant eye drop product. Over a 3 month period, each product was administered topically to 1 of 2 separate groups of patients’ eyes.
The primary endpoint of the study was a change in the corneal/conjunctival staining score based on the National Eye Institute (NEI) Industry Grading System after 3 months of treatment. This measurement is a standard for objectively assessing the severity of damage caused by eye dryness.
The secondary endpoints were a change in the corneal/conjunctival staining score after 1 month of treatment, as well as a change in quality of life based on patients’ completion of subjective questionnaires after 1 and 3 months of treatment.
The formula has been approved for the symptomatic treatment of DES in patients with Sjögren's syndrome in the Netherlands and Hungary.
Wize Pharma Completes Phase IV Study of LO2A for the Treatment of Dry Eye Syndrome in Patients with Sjögren's Syndrome [news release]. Hod Hasharon, Israel: Wize Pharma, Inc.; May 7, 2020. prnmedia.prnewswire.com/news-releases/wize-pharma-completes-phase-iv-study-of-lo2a-for-the-treatment-of-dry-eye-syndrome-in-patients-with-sjogrens-syndrome-301054900.html. Accessed May 11, 2020.