All Primary and Secondary Endpoints Were Achieved
LAVAL, QC and HEIDELBERG, Germany, April 13,
2021 /PRNewswire/ -- 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, double-masked, 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.4
About Novaliq
Novaliq is a biopharmaceutical company focusing on the development
and commercialization of first- and best-in-class ocular
therapeutics based on EyeSol®, the worldwide first water-free
technology. Novaliq offers an industry-leading portfolio addressing
today's unmet medical needs of millions of patients with eye
diseases. Novaliq GmbH is headquartered in Heidelberg, Germany and Novaliq Inc. has an office in
Cambridge, MA, USA. The long-term
shareholder is dievini Hopp BioTech holding GmbH & Co. KG, an
active investor in Life and Health Sciences companies. More
on www.novaliq.com.
About Bausch + Lomb
Bausch + Lomb, a leading global
eye health business of Bausch Health Companies Inc., is solely
focused on helping people see. Its core businesses include
over-the-counter products, dietary supplements, eye care products,
ophthalmic pharmaceuticals, contact lenses, lens care products,
ophthalmic surgical devices and instruments. Bausch + Lomb
develops, manufactures and markets one of the most comprehensive
product portfolios in the industry, which is available in
approximately 100 countries. For more information,
visit www.bausch.com.
About Bausch Health
Bausch Health Companies Inc.
(NYSE/TSX: BHC) is a global company whose mission is to improve
people's lives with our health care products. We develop,
manufacture and market a range of pharmaceutical, medical device
and over-the-counter products, primarily in the therapeutic areas
of eye health, gastroenterology and dermatology. We are delivering
on our commitments as we build an innovative company dedicated to
advancing global health. More information can be found at
www.bauschhealth.com.
Forward-looking Statements
This news release may
contain forward-looking statements, which may generally be
identified by the use of the words "anticipates," "expects,"
"intends," "plans," "should," "could," "would," "may," "believes,"
"estimates," "potential," "target," or "continue" and variations or
similar expressions. These statements are based upon the current
expectations and beliefs of management and are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those described in the forward-looking statements.
These risks and uncertainties include, but are not limited to, the
results of the additional development activities, registration and
approval of NOV03 and the risks and uncertainties discussed in
Bausch Health's most recent annual report on Form 10-K and detailed
from time to time in Bausch Health's other filings with the U.S.
Securities and Exchange Commission and the Canadian Securities
Administrators, which factors are incorporated herein by reference.
They also include, but are not limited to, risks and uncertainties
caused by or relating to the evolving COVID-19 pandemic, and the
fear of that pandemic and its potential effects, the severity,
duration and future impact of which are highly uncertain and cannot
be predicted, and which may have a material adverse impact on
Bausch Health, including but not limited to its project development
timelines, and costs (which may increase). Readers are cautioned
not to place undue reliance on any of these forward-looking
statements. These forward-looking statements speak only as of the
date hereof. Bausch Health undertakes no obligation to update any
of these forward-looking statements to reflect events or
circumstances after the date of this news release or to reflect
actual outcomes, unless required by law.
References
- Leonardi A, Modugno RL, Salami E. Allergy and Dry Eye Disease.
Ocul Immunol Inflamm. 2021 Feb 5:1-9. doi:
10.1080/09273948.2020.1841804. Epub ahead of print. PMID: 33544639.
Available at https://pubmed.ncbi.nlm.nih.gov/33544639/. Accessed on
4/8/21.
- Sun M, Moreno IY, Dang M, Coulson-Thomas VJ. Meibomian Gland
Dysfunction: What Have Animal Models Taught Us? Int J Mol Sci. 2020
Nov 21;21(22):8822. doi: 10.3390/ijms21228822. PMID: 33233466;
PMCID: PMC7700490. Available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7700490/ Accessed
4/8/21
- In December 2019, Bausch Health acquired the rights from
Novaliq GmbH to pursue development and commercialization of NOV03
for DED and combination products based on NOV03 in additional
ophthalmic indications in the United
States and Canada.
- Tauber J, Wirta DL, Sall K, Majmudar PA, Willen D, Krösser S;
SEECASE study group. A Randomized Clinical Study (SEECASE) to
Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of
Dry Eye Disease. Cornea. 2020 Dec 22; Publish Ahead of Print.
Any product/brand names and/or logos are trademarks of the
respective owners.
© 2021 Bausch & Lomb Incorporated or
its affiliates.
Novaliq Media Contact:
Simone
Angstmann-Mehr
info@novaliq.com
Bausch Health Investor Contact:
Arthur Shannon
arthur.shannon@bauschhealth.com
(514) 865-3855
(877) 281-6642 (toll free)
Bausch Health Media Contact:
Lainie Keller
lainie.keller@bauschhealth.com
(908) 927-1198
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