Abstract
Purpose :
Phase 2b/3 study VISTA-1 and Phase 3 study VISTA-2 were designed to identify the optimal dose of mitochondrial reactive oxygen species (mtROS) scavenger Visomitin (SkQ1 ophthalmic solution) in patients diagnosed with dry eye disease (DED) and to identify potential primary endpoints for the pivotal study VISTA-3.
Methods :
VISTA-1 and VISTA-2 were multi-center, double-masked, randomized, placebo-controlled studies, each comprising 5 visits over the course of 9 weeks. In VISTA-1, qualified subjects (n=451) were randomized 1:1:1 to receive low or high dose of Visomitin or placebo. In VISTA-2, qualified subjects (n=610) were randomized 1:1 to receive either high dose Visomitin or placebo. In VISTA-1, the co-primary endpoints were change from baseline to Visit 5 (Day 57) in central corneal fluorescein staining (Ora Calibra® Fluorescein Staining Scale) and the change in grittiness (Ora Calibra® 4 Symptom Scale). In VISTA-2, the co-primary endpoints were change from baseline to Day 57 in conjunctival fluorescein staining and in ocular discomfort (Ora Calibra® Ocular Discomfort Scale). Key pre-determined secondary endpoint included the change from baseline to Visit 3 (Day 29) in central corneal fluorescein staining.
Results :
The co-primary endpoints of both studies were not met, but in VISTA-2 Visomitin demonstrated statistically significant superiority in the key pre-determined secondary endpoint of change from baseline to Visit 3 (Day 29) in central corneal fluorescein staining (p<0.05) relative to vehicle in a large sub-population defined by Schirmer’s score. Similar statistically significant improvements in patients treated with Visomitin were observed in the VISTA-1 study. Importantly, in that sub-population both studies demonstrated statistically significant superiority of Visomitin (p<0.05) relative to vehicle in clearing of corneal fluorescein staining at Day 29.
Conclusions :
Visomitin ophthalmic solution, a drug designed for protecting the ocular surface from oxidative stress at mitochondrial level, demonstrated statistically significant effects on clearing of corneal staining in both VISTA-1 and VISTA-2 studies, which is a highly clinically relevant result. These findings provide support for using clearing of corneal fluorescein staining as the primary endpoint in a forthcoming pivotal study (VISTA-3).”
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.