Phase 3 study of NOV03 for DED completes enrollment
The first of two Phase 3 studies evaluating NOV03 (perfluorohexyloctane; Bausch + Lomb) as a first-in-class investigational drug to treat the signs and symptoms of Dry eye disease (DED) associated with Meibomian gland dysfunction (MGD) has been completely enrolled with a total of 599 participants, according to a company press release.
In a Phase 2 clinical study (SEECASE), NOV03 met its primary efficacy endpoint of statistically significant improvement of total corneal fluorescein staining over control at 8 weeks and statistically significant improvement of certain symptoms of the study period. Results were published in Cornea: The Journal of Cornea and External Disease.
“We are committed to addressing the unmet needs of patients, and believe NOV03, if approved, may be a first-in-class treatment option for the millions of patients who suffer from Dry eye disease associated with Meibomian gland dysfunction,” said Joseph C. Papa, chairman and CEO, Bausch Health in a press release. “This continued progress in our Phase 3 program and the published results of the SEECASE study are both exciting milestones in our development journey for NOV03.”
“Dry eye disease is one of the most common ocular surface disorders causing discomfort for millions of Americans,” said Joseph Tauber, MD, founder of Tauber Eye Center and lead author of the publication in a press release. “Given the key role Meibomian gland dysfunction plays in the pathogenesis of this disease, we are very encouraged by the findings in the SEECASE study, which demonstrate the potential for NOV03 as a possible treatment for those with highly symptomatic DED associated with MGD, and look forward to the results of the Phase 3 studies.”
Read the full press release here.