LAVAL, Quebec, and HEIDELBERG, Germany, April 13, 2021 – Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health” or the “Company”), and Novaliq GmbH, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics, today announced statistically significant topline data from the first Phase 3 trial (GOBI trial) evaluating the investigational drug NOV03 (perfluorohexyloctane) as a first-in-class eye drop with a novel mechanism of action to treat the signs and symptoms of dry eye disease (DED) associated with meibomian gland dysfunction (MGD).
Dry eye disease is one of the most common ocular surface disorders causing discomfort for millions of Americans, with MGD playing a key role in the development of the disease.1,2 The GOBI trial met both of its co-primary endpoints, including:
Change from baseline in total Corneal Fluorescein Staining (tCFS), a measure of assessing damage to the eye, achieved statistical significance at day 15 [p-value = 0.001] (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control [p-value < 0.001],
Change from baseline in dryness score achieved statistical significance at day 15 [p-value = 0.009] (secondary endpoint), with continued results through day 57 (primary endpoint) compared to control [p-value < 0.001], as rated on a visual analogue scale (VAS) ranging from 0-100 (0 = no discomfort; 100 = maximum discomfort).
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.
“More than 16 million adults in the United States have some form of dry eye disease, with meibomian gland dysfunction as a known cause for a majority of these cases2,” said Joseph C. Papa, chairman and CEO, Bausch Health. “The rapid onset of action and statistical significance demonstrated in this trial is impressive. It also gets us a step closer to bringing forward this potential first-in-class treatment option, which could be a promising development for millions of patients.”
“I am very impressed by the positive results from this first Phase 3 study of NOV03, in particular the findings at day 15 in treating the signs and symptoms of the disease,” said Joseph Tauber, M.D., founder of Tauber Eye Center in Kansas City, Mo., and trial investigator. “These findings validate the importance of the continued development of NOV03, and I look forward to seeing additional results from the Phase 3 program.”
The Phase 3 program for NOV03 includes an ongoing second Phase 3, multi-center, randomized, doublemasked, saline-controlled trial (MOJAVE study) and a multi-center, open-label, single-arm 12-month safety extension trial (KALAHARI study). Topline results from MOJAVE, if positive, will allow for a filing to the U.S Food and Drug Administration in 2022.
“We are very pleased with both the robustness and consistency of the results demonstrated in the GOBI trial as they confirm all efficacy and safety results from the previous Phase 2 SEECASE trial,” said Christian Roesky, Ph.D., CEO, Novaliq. “NOV03 has a novel mode of action specifically designed to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction, and we look forward to completing the program in close collaboration with Bausch Health and Bausch + Lomb.”
Summary of Phase 3 GOBI Study Results
The data was based on results from 597 participants aged 18 years and older who were randomized to either receive treatment with NOV03 four times daily or administration of placebo (saline solution) four times daily.
The multi-center, randomized, double-masked, saline-controlled Phase 3 study, which was conducted at 26 location in the United States, also included four prespecified secondary endpoints, which all demonstrated statistical superiority over placebo: change from baseline in tCFS at day 15 [p-value = 0.001]; change from baseline in dryness score at day 15 [p-value = 0.009]; change from baseline in VAS burning/stinging at day 57 [p-value = 0.006]; and change from baseline in central Corneal Fluorescein Staining (cCFS) at day 57 [p-value < 0.001].
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. Overall, the number of patients reporting at least one ocular TEAE was similar between the treatment and control arms: 9.6% and 7.5% for the treatment and control arms, respectively.
“I would like to thank the patients and doctors who participated in this study, as well as our research and development team for their dedication and hard work in helping to achieve this important milestone, particularly amid the added complexities brought on by the COVID-19 pandemic,” said Mr. Papa.
About NOV03 (perfluorohexyloctane) Ophthalmic Solution
NOV03 is an investigational, proprietary, water-free and preservative-free solution, based on patented EyeSol® technology from Novaliq GmbH.3 In 2019, Bausch Health and Bausch + Lomb acquired an exclusive license for the commercialization and development of NOV03 in the United States and Canada, and together, they announced in November 2020 that they have initiated the second of two Phase 3 studies to evaluate NOV03. In January 2021, they announced a Phase 2 clinical study (SEECASE) evaluating NOV03 was published in Cornea: The Journal of Cornea and External Disease.