• 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 the recent Phase 3 study (GOBI), NOV03 met all primary and secondary endpoints, including improvement of :

  • Change from baseline in total Corneal Fluorescein Staining (tCFS), a measure of assessing damage to the eye, achieved statistical significance at day 15, with continued results through day 57 compared to control
  • Change from baseline in dryness score achieved statistical significance at day 15, with continued results through day 57 compared to control, as rated on a visual analogue scale (VAS)
  • The GOBI trial also met all of its secondary endpoints, showing statistically significant improvements in both the signs and symptoms of DED associated with MGD that were studied
  • NOV03 was well tolerated with instillation site reactions below 0.5%
  • No treatment emergent adverse events (TEAEs) were reported by more than 2% of subjects in either treatment group

Results demonstrated in the GOBI trial confirm all efficacy and safety results from the previous Phase 2 SEECASE trial.

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.

The Phase 3 program for NOV03 includes the successful GOBI trial from 597 participants, an completely enrolled second Phase 3, multi-center, randomized, doublemasked, saline-controlled trial (MOHAVE) with a total of 622 participants and an ongoing multi-center, open-label, single-arm 12-month safety extension trial (KALAHARI).

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 ongoing phase 3 study in China started in February 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.