Study: To assess the efficacy, safety, and tolerability of N
NOV03 has a unique dual mode of action to address dry eye disease (DED) associated with meibomian gland dysfunction. SEECASE evaluated the efficacy, safety, and tolerability of NOV03 at 2 dosing regimens compared with a saline comparator in patients with DED.

A total of 336 DED patients were randomized in a 2:2:1:1 manner to NOV03 4 times daily (QID), NOV03 twice daily (BID), saline BID, and saline QID, respectively. The primary efficacy endpoint was tCFS staining at 8 weeks for both the regimens. Secondary endpoints included visual analog scales and the Ocular Surface Disease Index questionnaire for symptom assessment.

--The study met its primary endpoint, change from baseline of tCFS over control, for both dosing regimens QID and BID.

--NOV03 also showed pronounced improvement in various symptoms. For the Eye Dryness Score, changes from baseline were statistically significant compared with those of the control at week 8.

--Benefits on tCFS and symptoms started at 2 weeks after start of treatment and were maintained over the study duration.

--The effects were dosing schedule dependent. NOV03 was well tolerated with instillation site reactions below 3% in both treatment regimes.

NOV03 improves signs and symptoms in patients with highly symptomatic evaporative dry eye disease, according to the SEECASE research.