SAN DIEGO — NOV03, a novel, single chemical entity molecule, showed improvement in evaporative dry eye symptoms in the phase 2 SEECASE trial, Joseph Tauber, MD, said at the American Society of Cataract and Refractive Surgery meeting.
The randomized, double-masked, comparison trial included two dosing schedules of NOV03 (perfluorohexyloctane, Novaliq), twice daily and four times daily, and one dosing schedule of saline.
“Because NOV03 does not have a vehicle per se – being a single chemical entity – saline was selected by the FDA as the comparator eye drop,” Tauber said.
At 8 weeks, total corneal fluorescence staining was significantly reduced in both of the NOV03 groups, with a change of 1.8 units in the twice daily group and 2.3 units in the four times daily group, compared to 1 unit for saline.
At every time point recorded, including the 2-week mark, the NOV03 groups had statistically significant changes in fluorescence staining, according to Tauber.
“OSDI scores also improved by about 20 points from the baseline values,” he said.
Subgroup analysis showed the greatest amount of improvement in patients who had evaporative dry eye disease markers including higher baseline meibomian gland scores and Schirmer’s scores.
Less than 3% of patients experienced any type of intolerance to NOV03 and there were no significant adverse events reported.
“NOV03 is a unique compound with characteristics well suited for the treatment of evaporative dry eye, including stabilization of the tear film,” Tauber said. “It showed marked improvement in the signs and symptoms of the primary endpoint at 8 weeks and as early as 2 weeks.”
A confirmatory study is planned for later this year. – by Rebecca L. Forand
Tauber J. Randomized, double-masked, comparator-controlled phase 2 trial to evaluate NOV03 (perfluorohexyloctane) for treatment of dry eye disease. Presented at American Society of Cataract and Refractive Surgery annual meeting; May 3-7, 2019; San Diego.
Disclosure: Tauber reports he is a paid investigator for Novaliq.