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