Study shows NOV03 safe, effective for dry eye
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NOV03 treatment was found to reduce signs and symptoms of dry eye disease in a phase 2 clinical study.
“An improved tolerability profile versus currently available therapies is important for the clinical management of DED [dry eye disease] in practice, considering that up to 60% of patients stop their therapy within 12 months,” wrote Joseph Tauber, MD, of the Tauber Eye Center, and colleagues.
Researchers conducted a randomized, double-masked, saline-controlled clinical study to evaluate the safety, efficacy and tolerability of NOV03 compared to saline. Three hundred thirty-six DED patients were randomized to receive NOV03 four times a day, NOV03 twice a day, saline twice a day or saline four times daily. After 8 weeks, patients were analyzed for total corneal fluorescein staining (tCFS), and an Ocular Surface Disease Index questionnaire was administered to assess patient symptoms.
According to the data, tCFS decreased in both NOV03 regimens, showing a higher degree than the saline groups, with four-times-a-day dosing showing larger decreases than the two-times-a-day dosage. Increased symptom relief was seen more frequently with the four-times-a-day NOV03 dosage than with the two-times-a-day NOV03 dosage.
Adverse events were seen in 26.2% of patients. They included blurred vision in the NOV03 four-times-a-day group, eye irritation in the NOV03 twice-a-day group and eye pain in the saline groups.
Researchers concluded that the safety and tolerability of NOV03 treatment could lead to advances in the clinical management of dry eye disease.
“This phase 2 study has demonstrated the therapeutic ability of NOV03 to reduce signs and symptoms of DED, thereby showing the potential of its novel mode of action to address the clinical management of patients with DED associated with meibomian gland dysfunction,” wrote Tauber and colleagues.
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