NOV03 shows benefit in dry eye disease
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WASHINGTON — Patients with dry eye disease treated with NOV03 eye drops experienced improvements in both signs and symptoms, according to a study.
At the American Society of Cataract and Refractive Surgery meeting, Joseph Tauber, MD, said it is believed that the majority of patients with dry eye have meibomian gland dysfunction. NOV03 (Novaliq/Bausch + Lomb) is aimed at addressing that dysfunction.
“Despite hundreds of [over-the-counter] products and five FDA-approved products for dry eye on the market, it is believed that only 2 million of these patients are using therapeutics chronically, leaving a great unmet need.” Tauber said. “[NOV03] is a potent inhibitor of tear evaporation.”
Researchers explored the efficacy and safety of NOV03 in a randomized trial comprising 597 patients with a self-reported history of dry eye disease in both eyes. The primary endpoints of the study were change from baseline in total corneal fluorescein staining and change from baseline in dryness score at day 57. Patients were randomly assigned to receive NOV03 or hypotonic saline four times daily for 8 weeks.
Patients in the NOV03 group experienced greater change in both total corneal fluorescein staining and dryness score at day 57 compared with saline (both P < .001). Patients also achieved early results, with a statistical difference observed at day 15 compared with saline.
Tauber said no serious ocular adverse events were reported.
“All key secondary endpoints were also met,” he said. “NOV03 was well tolerated and displayed an excellent safety profile.”
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Tauber J. Efficacy of perfluorohexyloctane on signs and symptoms of dry eye disease associated with meibomian gland dysfunction: The Gobi study. Presented at: American Society of Cataract and Refractive Surgery meeting; April 22-26, 2022; Washington.
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