Published in the American Journal of Ophthalmology, Bausch + Lomb Corporation and Novaliq GmbH have released results from their second pivotal MOJAVE phase 3 trial on NOV03 (perfluorohexyloctane) for dry eye disease (DED) associated with meibomian gland dysfunction (MGD).
Tell me more about NOV03
NOV03 is an investigational proprietary, non-steroidal, water-free, and preservative-free ophthalmic drop based on Novaliq’s patented EyeSol technology.
The drop spreads rapidly across the ocular surface due to its low surface tension, and interacts with the lipophilic part of the tear film that prevents tear evaporation.
It also can penetrate the meibomian glands, where it interacts with and dissolves altered, viscous meibum in the glands.
Give me some background on its development.
Novaliq entered into a strategic cooperation agreement with Bausch + Lomb in 2019 to develop, manufacture, and commercialize NOV03 in the U.S. and Canada.
The FDA accepted its new drug application (NDA) filing in September 2022.
What did the first phase 3 trial find?
Data from the first pivotal MOJAVE trial showed that NOV03 demonstrated statistically significant and clinically meaningful improvements for patients with DED associated with MGD in comparison to a placebo (hypotonic saline). Additionally, DED signs and symptoms were well tolerated.
Now talk about this second phase 3 trial.
The second pivotal MOJAVE trial was a multi-center, randomized, hypotonic saline-controlled, double-masked study. A total of 620 patients (ages 18+) with DED were randomized to receive either NOV03 four times a day (n = 311) or the hypotonic solution four times a day (n=309) for eight weeks.
Primary endpoints included change from baseline at Week 8 in total corneal fluorescein staining (tCFS) and eye dryness Visual Analog Scale (VAS) Score.
Secondary endpoints included change from baseline in eye dryness VAS Score and tCFS at Week 2 and eye burning/stinging VAS score and central corneal fluorescein staining (cCFS) at Week 8.
Results?
At Week 8, for the primary endpoints, reduction from baseline in tCFS was statistically greater in the NV03 group compared to control (-1.2 vs -0.8, P < .001); and the VAS dryness score was statistically significantly improved for the NOV03 arm compared to control (-14.4 vs -6.1, P < .001).
At Week 2, for secondary endpoints, tCSF and VAS dryness score were both statistically significant compared to saline: –1.0 vs -0.2 (P = .001) for tCSF; -11.3 vs -4.3 (P < .001).
And at Week 8, VAS burning/stinging score and cCFs were greater in the NOV03 group: -11,3 vs -3.4 (P < .001) and -0.5 vs -0.2 (P < .001), respectively.
Any adverse events?
Ocular adverse events (AEs) were found in 12.9% of the NOV03 group and 12.3% in the control group, while treatment-related ocular AEs occurred in 6.4% (NOV03 group) and 6.8% (control group).
The most common AEs among the NOV03 group included blepharitis, conjunctival hyperemia and papillae, ocular hyperemia, blurred vision, and VA reduction.
Significance?
With no current FDA-approved therapies that directly target evaporation in DED associated with MGD, the data holds promise for NOV03 to be the first, pending approval.
What’s next?
A target Prescription Drug User Fee Act (PDUFA) action date has been set for June 28, 2023.