Wize Pharma Announces Positive Topline Results in Phase 4 Study of LO2A for Dry Eye in Patients with Sjögren’s Syndrome

Wize Pharma reported topline results from its phase 4 clinical trial of its in-license eye drop formula, LO2A, for the symptomatic treatment of dry eye syndrome (DES) in patients with Sjögren’s syndrome.

The randomized, double-masked comparative study evaluated LO2A versus Alcon’s Systane Ultra UD (comparator), an over-the-counter lubricant eye drop product used to relieve dry and irritated eyes in DES patients, which is also used to treat dry eye in patients with Sjögren’s syndrome.

The study was performed in five centers in Israel and was classified as a phase 4 exploratory study, since LO2A is already approved for marketing in Israel for DES patients.

The study design included 69 patients (138 eyes) with Sjögren’s syndrome experiencing DES that were randomized in a 1:1 ratio into two treatment groups, LO2A or Systane Ultra UD. Drops were administered topically to the eye over a 3-month period.

The primary endpoint of the study was change in corneal staining score, using the National Eye Institute (NEI) Industry Grading System after 3 months of study treatment. This is an objective measure used to determine the severity of the damage caused by dryness of the eye.

Secondary endpoints included a conjunctival staining score after 1 month of treatment and changes in quality of life with subjective questionnaires, including Ocular Surface Disease Index (OSDI) and Visual Analogue Scale (VAS) score after 1 and 3 months of treatment.

Clinically significant results were defined as a reduction of 3 points in corneal and conjunctival staining and an improvement of 30 points in VAS and of 10 points in OSDI measurements.

Topline results include:

• LOA2 met its primary endpoint of noninferiority vs. comparator at the 3-month time point in corneal staining with a p value of 0.001.
• LO2A continued, as in prior trials, to demonstrate a good safety profile with no major adverse events or side effects reported.
• A numeric advantage was evident in both the signs and symptoms of DES for patients using LO2A vs. the comparator in the subgroup of patients with primary Sjögren’s (11 and 17 patients with primary Sjögren’s were in the LO2A and Control groups, respectively).
• LO2A demonstrated clinically meaningful improvement in both the signs and symptoms of DES in patients suffering from Sjögren’s – 100% of the patients treated with LO2A showed a clinically significant improvement in at least one of the primary and secondary end point measurements included in the trial at the 3-month time point vs. 90% of patients treated with comparator. In addition, among the LO2A treatment group, 74% of patients showed a clinically significant improvement in both signs and symptoms vs. 59% in the comparator group.
• For the subset of patients with primary Sjögren’s, average conjunctival staining at the 3-month time point was reduced on average by 4.1 points by LO2A, compared to an average reduction of 2.7 points by the comparator, marking about a 52% difference.
• For the subset of patients with primary Sjögren’s, there was an average reduction of 37.4 points in the eye dryness score measured by VAS in the group treated by LO2A, compared to an average reduction of 21.4 points in the comparator group at the 3-month time point, resulting in approximately a 75% difference.

“We are pleased with these topline results, especially given the clinical improvement in signs and symptoms. Sjögren’s patients that are suffering from dry eye tend to develop severe dry eye, and we believe LO2A has clearly demonstrated its ability to improve both signs and symptoms of these patients. LO2A appears to be a promising proposition to this sub-group of patients and in-line with the growing need for personalized treatment. Sjögren’s patients suffering from dry eye currently have no approved treatment available and this data supports our plans to monetize our rights in the LO2A technology,” Noam Danenberg, CEO of Wize, said in a company news release.

Dr. Penny Asbell, MD, Chair of the Department of Ophthalmology at The University of Tennessee Health Science Center and Director of the Hamilton Eye Institute, commented, “Dry eyes are typically one of the most bothersome symptoms associated with Sjögren’s syndrome. This subpopulation of dry eye is often especially bothered by ocular discomfort, blurred vision, and visual fatigue affecting their quality of life, and with little specific treatment to address their symptoms. The LO2A clinical trial is an important step in finding new treatments for dry eye associated with Sjögren’s.”

LO2A is approved for the symptomatic treatment of DES in patients with Sjögren’s syndrome in the Netherlands and Hungary.