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 (perfluorohexyloctane) is an investigational, proprietary, water-free, non-steroidal, single-component preservative-free eye drop.
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.
The clinical development program for NOV03 includes two Phase 3 studies (GOBI and MOJAVE), both of which demonstrated statistically significant improvement vs. control for both primary and key secondary sign and symptom endpoints as early as day 15 and through day 57. NOV03 was well tolerated in both studies. Results demonstrated in the two Phase 3 studies confirm all efficacy and safety results from the previous Phase 2 SEECASE trial.
Data from the first pivotal Phase 3 trial (GOBI) were presented at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in Washington, D.C. on April 24, 2022. Data from the second pivotal Phase 3 trial (MOJAVE) were presented at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022. Results from the pivotal Phase 2 trial (SEECASE) were published in Cornea in September 2021.5 The clinical program for NOV03 concluded with the completion of a multi-center, open-label, single-arm, 12-month safety extension trial (KALAHARI).
Dry eye disease (DED) is one of the most common ocular surface disorders, with Meibomian gland dysfunction (MGD) as a major cause of development and progression, affecting approximately nine out of 10 people with DED. DED due to MGD is caused by a deficient tear film lipid layer that leads to increased tear evaporation. There is currently no approved prescription eye drop in the United States or China for DED associated with MGD.
Since December 2019, Novaliq has a strategic cooperation with Bausch + Lomb to develop, manufacture and commercialize NOV03 (perfluorohexyloctane) in USA and Canada. In September 2022 acceptance of filing of a New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) was announced for NOV03 for the proposed indication of treating the signs and symptoms of dry eye disease (DED) associated with Meibomian gland dysfunction (MGD). Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
In China Novaliq has a strategic cooperation with Jiangsu Hengrui Pharmaceuticals to develop, manufacture and commercialize NOV03 for the treatment of dry eye disease in China.
In December 2021 Hengrui announced positive results from pivotal Phase 3 clinical trial of SHR8058 (=NOV03) for the treatment of dry eye disease associated with Meibomian gland dysfunction at 17 sites across China. All primary endpoint were met with high statistically significance. At the same time, SHR8058 eye drops were safe, reliable and well tolerated. The company further stated that it will submit the SHR8058 drug marketing authorization applications to the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China in the near future.
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
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).
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.