The study by the team led by Joseph Tauber found that NOV03 ophthalmic drops was safe and effective in patients with dry eye disease (DED) associated with meibomian gland dysfunction (MGD). The findings of this study were published in Ophthalmology Journal.
NOV03 (perfluorohexyloctane) is a new ophthalmic drop that has been developed for the treatment of dry eye disease (DED) associated with meibomian gland dysfunction (MGD). DED is a common condition that is characterized by a lack of sufficient lubrication and moisture in the eye, leading to discomfort, pain, and reduced vision. MGD is a condition that affects the glands in the eyelids that produce the oily layer of the tear film, which helps to stabilize the tears and prevent evaporation. When these glands are not functioning properly, it can lead to DED.
The eight-week, phase 3, multicenter study included 597 patients who were randomized to receive either NOV03 or hypotonic saline drops four times daily. The primary endpoint was change from baseline in total corneal fluorescein staining (tCFS) at week 8, and the primary symptom endpoint was change from baseline in eye dryness score at week 8. Key secondary endpoints included changes in tCFS and eye dryness at week 2, eye burning/stinging at week 8, and central corneal fluorescein staining at week 8.
The findings of the study were:
NOV03 significantly improved tCFS and eye dryness compared to saline at week 8.
Improvements from baseline also significantly favored NOV03 on all key secondary endpoints, including tCFS and eye dryness at week 2, eye burning/stinging at week 8, and central corneal fluorescein staining at week 8.
Most adverse events were mild in severity, and there were no serious ocular adverse events. One patient discontinued NOV03 due to eye irritation.
Source:
Tauber, J., Berdy, G. J., Wirta, D. L., Krösser, S., & Vittitow, J. L. (2022). NOV03 for Dry Eye Disease Associated With Meibomian Gland Dysfunction: Results of the Randomized Phase 3 GOBI Study. In Ophthalmology. Elsevier BV. https://doi.org/10.1016/j.ophtha.2022.12.021