NOV03 Met Both Primary Endpoints for Signs and
Symptoms of Dry Eye Disease
VAUGHAN,
ON and LAVAL, QC and
HEIDELBERG, Germany, April 25,
2022 /PRNewswire/ -- Bausch + Lomb, a leading global
eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC)
("Bausch Health"), and Novaliq GmbH, a biopharmaceutical
company focusing on first- and best-in-class ocular therapeutics,
today announced that data from the first pivotal Phase 3 trial
(GOBI) of NOV03 (perfluorohexyloctane), which is being investigated
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), was presented yesterday as
part of a podium presentation on April
24, 2022, at the American Society of Cataract and
Refractive Surgery (ASCRS) annual meeting in Washington, D.C.
"The data show that NOV03 met both primary endpoints of total
Corneal Fluorescein Staining, a measure that assesses damage to the
eye, and visual analogue scale dryness score at day 57," said
Joseph Tauber, M.D., founder of
Tauber Eye Center in Kansas City,
Mo., and leading NOV03 trial investigator. "The fact that
NOV03 met both primary endpoints in a single study, which is a rare
event in clinical trials in dry eye disease, reinforces its
potential as a treatment for addressing both the signs and symptoms
of the disease. The unique mechanism of action makes NOV03 an
exciting investigational treatment for the signs and symptoms
of dry eye."
DED is one of the most common ocular surface disorders, causing
discomfort for millions of Americans. MGD is a major cause of the
development and progression of evaporative DED, which is caused by
a deficient tear film lipid layer that leads to increased tear
evaporation.1,2
"There is currently no pharmaceutical therapy in the United States approved for the treatment
of dry eye disease associated with Meibomian gland dysfunction, and
these data support NOV03 as a potential first-in-class option for
the treatment of dry eye disease associated with Meibomian gland
dysfunction," said Joseph C. Papa,
chairman and CEO, Bausch Health. "We
intend to submit for approval during the second quarter of
2022."
The data from the Phase 3, multicenter, randomized, hypotonic
saline-controlled, double masked GOBI study was based on results
from 597 participants ages 18 years and older who were randomized
to either receive treatment with NOV03 four times daily or hyptonic
saline solution four times daily (n=303 NOV03; n=294 saline). The
key points of the study include:
- On day 57, change from baseline in total Corneal Fluorescein
Staining (tCFS) was statistically significant in the NOV03 arm
compared to the control saline group (-2.0 [2.6] vs. -1.0 [2.7])
(P<0.001) (primary endpoint).
- Additionally on day 57, eye dryness VAS score was statistically
significantly improved in the NOV03 arm compared to control group
(-27.4 [27.9] vs. -19.7 [26.6]) (P<0.001) (primary
endpoint).
- tCFS and eye dryness VAS score was also statistically
significant at day 15 (secondary endpoint).
In the study, NOV03 was well tolerated with few subjects
experiencing ocular adverse events (AE) (8.3% NOV03 group, 5.1%
control group). Blurred vision, mostly mild and transient, was the
only AE that occurred in a higher proportion of subjects treated
with NOV03 versus control (3.0% vs 0.3%).
"With its novel mode of action, NOV03 is specifically designed
to alleviate the signs and symptoms of dry eye disease associated
with Meibomian gland dysfunction, and if approved, has the
potential to address an unmet medical need," said Christian Roesky, Ph.D., CEO, Novaliq. "We look
forward to our continued collaboration with Bausch Health and
Bausch + Lomb as we work together to potentially bring this novel
treatment option to patients in the
United States."
About NOV03 (perfluorohexyloctane) Ophthalmic
Solution
NOV03 is an investigational, proprietary,
water-free, single-component preservative-free eye
drop.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. In addition to the GOBI
trial, positive topline data was announced from the second
Phase 3 study (MOJAVE) in September
2021. Additional data from MOJAVE will be shared later this
year during a future medical congress and scientific
publication.
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 dedicated
to protecting and enhancing the gift of sight for millions of
people around the world – from the moment of birth through every
phase of life. Its comprehensive portfolio of more than 400
products includes contact lenses, lens care products, eye care
products, ophthalmic pharmaceuticals, over-the-counter products and
ophthalmic surgical devices and instruments. Founded in 1853,
Bausch + Lomb has a significant global research and development,
manufacturing and commercial footprint with more than 12,000
employees and a presence in nearly 100 countries. Bausch + Lomb is
headquartered in Vaughan, Ontario
with corporate offices in Bridgewater,
New Jersey. For more information,
visit www.bausch.com and connect with us on Twitter,
LinkedIn, Facebook and Instagram.
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. For more information, visit
www.bauschhealth.com and connect with us on Twitter and
LinkedIn.
Forward-looking Statements
This news release may
contain forward-looking statements, which may generally be
identified by the use of the words "anticipates," "hopes,"
"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 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, launches 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.
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
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
3/23/22.
- Findlay Q, Reid K. Dry eye
disease: when to treat and when to refer. Aust Prescr.
2018;41(5):160-163. doi:10.18773/austprescr.2018.048. Available at
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6202299/. Accessed
3/23/22.
- 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.
© 2022 Bausch & Lomb Incorporated or its
affiliates.
BLNP.0029.USA.22
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