Bilateral Effect of OC-01 (Varenicline Solution) Nasal Spray for Treatment of Signs and Symptoms in Individuals with Mild, Moderate, and Severe Dry Eye Disease

Efficacy and safety of trigeminal parasympathetic pathway stimulation for dry eye: A systematic review and meta-analysis

“…Although no direct comparisons have been made between TPP stimulation and treatments such as lifitegrast and CsA, the results of the matching-adjusted indirect comparison (MAIC) showed that the improvement in Schirmer’s test score with the OC-01 nasal spray is much higher than 5% lifitegrast [ 43 ] and 0.05% CsA,[ 44 ] even several times higher, which is very valuable. Several post hoc studies on OC-01 nasal spray have shown consistent treatment effectiveness in a wide range of dry eye patients, regardless of age, race, ethnicity, artificial tear use,[ 45 ] severity (mild, moderate, or severe),[ 46 47 ] risk factors (e.g., menopause[ 48 ] and use of systemic anticholinergics or antidepressants or anxiolytics),[ 49 ] and demonstrated efficacy in both eyes. [ 47 ] The treatment benefit results of these subgroups are consistent with the overall trial results of ONSET-1 and ONSET-2.…”

“…Several post hoc studies on OC-01 nasal spray have shown consistent treatment effectiveness in a wide range of dry eye patients, regardless of age, race, ethnicity, artificial tear use,[ 45 ] severity (mild, moderate, or severe),[ 46 47 ] risk factors (e.g., menopause[ 48 ] and use of systemic anticholinergics or antidepressants or anxiolytics),[ 49 ] and demonstrated efficacy in both eyes. [ 47 ] The treatment benefit results of these subgroups are consistent with the overall trial results of ONSET-1 and ONSET-2. [ 48 49 ] However, a premise that should not be overlooked is that the inclusion criteria for almost all studies required Schirmer’s test score to increase by at least 7 mm after swab stimulation compared with pre-stimulation in the same eye.…”