Phase 2 Study Published in Cornea: The Journal of Cornea and
External Disease; Study Met Primary Endpoint in Patients with
Highly Symptomatic Evaporative Dry Eye Disease Associated with
Meibomian Gland Dysfunction
LAVAL, QC and HEIDELBERG, Germany, Jan. 19,
2021 /CNW/ -- 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 pharmaceutical
company focusing on first- and best-in-class ocular
therapeutics, today announced the first of two Phase 3 studies
evaluating NOV03 as a first-in-class investigational drug with a
novel mechanism of action to treat the signs and symptoms of Dry
eye disease (DED) associated with Meibomian gland dysfunction (MGD)
has been completely enrolled with a total of 599 participants.
Additionally, a Phase 2 clinical study (SEECASE) evaluating the
efficacy, safety, and tolerability of NOV03 (perfluorohexyloctane)
ophthalmic solution in patients with DED associated with MGD has
been published in Cornea: The Journal of Cornea and
External Disease. In the study, NOV03 met its primary efficacy
endpoint of statistically significant improvement of total corneal
fluorescein staining over control at eight weeks. NOV03 also showed
statistically significant improvement of certain symptoms, such as
severity and frequency of dryness and burning/stinging of the eyes,
over the entire duration of the Phase 2 study.1
"We are committed to addressing the unmet needs of patients, and
believe NOV03, if approved, may be a first-in-class treatment
option for the millions of patients who suffer from Dry eye disease
associated with Meibomian gland dysfunction," said Joseph C. Papa, chairman and CEO, Bausch Health. "This continued progress in our
Phase 3 program and the published results of the SEECASE study are
both exciting milestones in our development journey for
NOV03."
"Dry eye disease is one of the most common ocular surface
disorders causing discomfort for millions of Americans," said
Joseph Tauber, M.D., founder of
Tauber Eye Center in Kansas City,
Mo., and lead author of the publication. "Given the key role
Meibomian gland dysfunction plays in the pathogenesis of this
disease, we are very encouraged by the findings in the SEECASE
study, which demonstrate the potential for NOV03 as a possible
treatment for those with highly symptomatic DED associated with
MGD, and look forward to the results of the Phase 3 studies."
Summary of Phase 2 SEECASE Study Results
The
prospective, multicenter, randomized, double-masked,
saline-controlled clinical study evaluated NOV03 at two dosing
regimens. The data published was based on results from 336 patients
age 18 years or older who were randomized to one of four treatment
groups: NOV03 four times daily (QID), NOV03 twice daily (BID),
saline BID or saline QID (a 2:2:1:1 ratio). The study met its
primary efficacy endpoint of statistically significant improvement
of total corneal fluorescein staining (tCFS) over control at eight
weeks. Data showed a change from baseline of tCFS over control, for
both dosing regimens (QID and BID, P < 0.001 and P = 0.009,
respectively). Effects on tCFS and symptoms started at two
weeks after start of treatment and were maintained over the study
duration. The effects were dosing schedule dependent. NOV03 was
well tolerated with instillation site reactions below 3% in both
treatment regimens.1
The SEECASE study was conducted at 12 ophthalmology practices in
the United States with patients
who had a history of DED in both eyes and if one eye (the same eye)
met the inclusion criteria at screening and at randomization time.
Several symptom assessments such as Eye Dryness Score measured
using visual analog scale (VAS), VAS for other symptoms such as
burning/stinging, itching, blurred vision, and sensitivity to
light, and Ocular Surface Disease Index (OSDI) were evaluated to
assess the effect of NOV03 on DED symptomatology.1
Patients treated with NOV03 also experienced statistically
significant improvement of certain DED symptoms over the entire
duration of the Phase 2 study. Changes from baseline were
statistically significant compared with those of the control group
at week eight [P < 0.001 (QID) and P = 0.002 (BID)]. Other
symptoms evaluated included burning/stinging, sticky feeling,
foreign body sensation, itching, blurred vision, sensitivity to
light and pain. The following treatment emergent adverse
events (TEAEs) reported by more than 2% of subjects were blurred
vision in the NOV03 QID group, eye irritation in the NOV03 BID
group and eye pain in the saline group. Overall the number of
patients reporting at least one TEAE was similar between the
treatment groups.1
"The results demonstrated in the SEECASE study support NOV03 as
a potential new treatment option for patients with DED associated
with MGD, and we look forward to learning the results from both of
the Phase 3 studies," said Christian
Roesky, Ph.D., CEO, Novaliq GmbH.
About NOV03 (perfluorohexyloctane) Ophthalmic
Solution
NOV03 is an investigational, proprietary,
water-free and preservative-free solution, based on patented
EyeSol® technology from Novaliq GmbH.2 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.
About Novaliq
Novaliq is a pharmaceutical 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
http://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
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
1. 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.
2. 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.
Any product/brand names and/or logos are trademarks of the
respective owners. © 2021 Bausch & Lomb Incorporated or its
affiliates. NPR.0025.USA.21
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)
|
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Bausch Health
Media Contact: Lainie Keller
lainie.keller@bauschhealth.com
(908) 927-1198
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