09.09.20

Sight Sciences Presents Additional Results of OLYMPIA Study of Signs and Symptoms of Dry Eye Disease Using TearCare

Source: Sight Sciences

Sight Sciences announced further favorable results of a trial evaluating a single treatment of TearCare for the treatment of signs and symptoms of dry eye disease in patients with meibomian gland dysfunction. TearCare is currently marketed for the application of localized heat to the eyelids for conditions such as meibomian gland dysfunction, dry eye, or blepharitis.

Data from the study were presented at the Women in Ophthalmology (WIO) 2020 Virtual Summer Symposium.

The OLYMPIA study was designed to evaluate the safety and effectiveness of a single TearCare procedure compared to a single LipiFlow procedure (Johnson & Johnson) in treating the signs and symptoms of dry eye disease. OLYMPIA was a prospective, randomized, multicenter trial that enrolled 235 dry eye patients at 10 U.S. sites. All the patients enrolled in the study had moderate to severe stage of dry eye disease associated with meibomian gland dysfunction. Seventy percent of enrolled patients were female.

Results from the OLYMPIA study in the subset of female subjects were presented at the Symposium by Jennifer Loh, MD, practicing ophthalmologist at Loh Ophthalmology in Miami. In the subset of female subjects, a greater proportion of female TearCare patients experienced meaningful symptomatic relief compared to female LipiFlow patients, as measured by an improvement from baseline in ocular surface disease index (OSDI) score at one month. In the study, 76% of female subjects receiving TearCare improved by at least one OSDI severity category at one month, as compared to 56% of LipiFlow female patients. Similarly, 90% of female subjects receiving TearCare were observed to have clinically meaningful reductions (10.4 point reduction in severe cases and 7.3 point reduction in moderate cases) in OSDI scores from baseline, as compared to 79% of female subjects receiving LipiFlow.

“We are proud to have Dr. Loh present these findings at the WIO Symposium, as we continue to evaluate TearCare for the treatment of dry eye disease,” Paul Badawi, Chief Executive Officer of Sight Sciences, said in a company news release. “We believe the OLYMPIA clinical results support the physiologic thesis behind the TearCare procedure for meibomian gland dysfunction, the leading cause of dry eye disease.”

The results of the OLYMPIA study show statistically significant and clinically meaningful improvement in the primary signs of dry eye at 2 weeks that lasted through the duration of the study. Subjects receiving TearCare were observed to have increased tear break-up time (TBUT) by 2.7 ± 3.7 at 2 weeks and by 3.0 ± 4.2 seconds at 1 month (both P < 0.0001), and meibomian gland secretion (MGS) score by 10.5 ± 10.9 at two weeks and by 11.2 ± 11.1 units at one month (both P < 0.0001) compared with baseline. Subjects receiving LipiFlow were also observed to have significantly increased TBUT and MGS score at two weeks and one month compared with baseline (all P < 0.0001). The improvements in signs for TearCare patients was numerically better compared to LipiFlow patients.

The results also show statistically significant and clinically meaningful improvement in symptoms measured as patient reported outcomes {OSDI, Symptom Assessment Questionnaire in Dry Eye (SANDE) and Eye Dryness Score (EDS)} at 1 month. Subjects receiving TearCare reported mean reductions of 27.6 ± 20.6, 38.2 ± 31.0 and 35.4 ± 34.1 respectively in OSDI, SANDE and EDS scores from baseline; all P < 0.0001. Subjects in the LipiFlow group reported mean reductions of 23.4 ± 17.7, 39.4 ± 25.9 and 34.8 ± 26.9 respectively in OSDI, SANDE and EDS scores from baseline; all P < 0.0001. TearCare subjects exhibited better symptomatic relief evidenced by requiring 22% less lubricant drops as a rescue therapy than LipiFlow subjects throughout the study period of 1 month (p<0.01). Adverse events in OLYMPIA (seven in the TearCare group and eight in the LipiFlow group) were transient, minor and resolved without requiring any further treatment.

Initial results from the OLYMPIA study were presented in May 2020 at the American Society of Cataract Refractive Surgery (ASCRS) Virtual Annual Meeting by Dr. Loh.

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