Bausch Health’s global eye health business Bausch + Lomb has begun the second of two Phase III studies analysing the investigational drug NOV03 (perfluorohexyloctane) for treating dry eye disease (DED) associated with meibomian gland dysfunction (MGD).
Based on patented EyeSol technology from Novaliq, NOV03 is a water-free and preservative-free solution.
DED is a chronic and serious disease of the ocular surface.
The first Phase III study is currently enrolling patients and has completed 85% of enrolment.
According to data from the Phase II study conducted on 336 patients, NOV03 showed statistically significant improvement in total corneal fluorescein staining over control at eight weeks, thereby meeting the primary efficacy endpoint.
Furthermore, NOV03 also showed significant improvement in certain symptoms such as severity and frequency of dryness and burning/stinging of the eyes, throughout the Phase II study.
No notable safety events were observed in the Phase II trial.
Bausch Health chairman and CEO Joseph Papa said: “Bausch + Lomb, our global eye health business, is focused on researching and bringing forward new options for unmet medical needs, including Dry Eye Disease associated with MGD.
“It’s estimated that more than 16 million Americans suffer from Dry Eye Disease, and if approved, NOV03 may be the first pharmaceutical therapy available for US patients who have Dry Eye Disease associated with MGD.”
In December 2019, Bausch Health acquired an exclusive license for the commercialisation and development of NOV03 in the US and Canada.
As per the licensing terms, Bausch Health agreed to pay upfront and milestone payments and sales royalties to Novaliq.
Furthermore, Bausch Health gained the right to pursue development and commercialisation of NOV03 for DED as well as combination products in additional ophthalmic indications in the US and Canada.