• NOV03

    First drug developed to treat signs and symptoms of evaporative dry eye disease

NOV03 (100% perfluorohexyloctane) is the first drug developed to treat dry eye disease (DED) associated with Meibomian gland dysfunction in a highly effective way.

NOV03 prevents excessive tear evaporation and has the ability to restores tear film balance. The investigational drug has a unique mode-of-action: It stabilizes the lipid layer for hours to protect the tear film and has the ability to penetrate the Meibomian glands.

In a Phase 2 study, NOV03 met its primary sign endpoint of improvement of total corneal fluorescein staining over control at eight weeks with high statistical significance (p<0.001). In addition, NOV03 showed statistically significant and clinically meaningful improvement in a variety of symptoms over the entire duration of the trial. A Phase 3 study in the U.S.A. is underway for NOV03.

Regulatory status of NOV03

NOV03 is a first-in-class investigational drug with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD).
The product is in late-stage clinical development. A phase 2 clinical trial (SEECASE) evaluating the efficacy, safety, and tolerability of NOV03 ophthalmic solution in patients with DED associated with MGD has been completed and is published in Cornea: The Journal of Cornea and External Disease.
Two phase 3 studies are ongoing in the U.S., enrollment of the first phase 3 study has been completed in January 2021 with 599 participants.
Based on the clinical development progress Novaliq expects a New Drug Application (NDA) submission in the U.S.A. in 2022.
In December 2020, China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) approved to carry out clinical studies with NOV03 (100% perfluorohexyloctane) for the treatment of dry eye in China.
The start of the phase 3 study in China is planned for the 1st half of 2021. The submission of the IND in China was the result of an effective collaboration between the development teams at Hengrui Medicine and Novaliq.
The project is running at Hengrui under the project number SHR 8058.

Publications

more information about the clinical trials.

Products

Our products target key drivers of the disease and have constantly demonstrated significant improvement in sign and symptoms of dry eye in clinical trials.