NOV03 Consistently Met Primary Endpoints for
Signs and Symptoms of Dry Eye Disease Associated with Meibomian
Gland Dysfunction
NOV03 PDUFA Action Date is June 28,
2023
Bausch + Lomb Corporation (NYSE/TSX: BLCO) (“Bausch + Lomb”), a
leading global eye health company dedicated to helping people see
better to live better, and Novaliq GmbH, a biopharmaceutical
company focusing on first- and best-in class ocular therapeutics,
today announced that American Journal of Ophthalmology has
published results from MOJAVE, the second pivotal Phase 3 trial for
NOV03 (perfluorohexyloctane). NOV03 is being investigated to treat
the signs and symptoms of dry eye disease (DED) associated with
Meibomian gland dysfunction (MGD). Results from the first pivotal
Phase 3 trial, GOBI, were published earlier this year in
Ophthalmology. The U.S. Food and Drug Administration (FDA) assigned
NOV03 a Prescription Drug User Fee Act (PDUFA) action date of June
28, 2023.
“In addition to meeting both primary sign and symptom efficacy
endpoints, NOV03 was shown to be very well tolerated in the MOJAVE
study. These are all critical factors that must be considered when
determining a treatment plan for someone with a chronic and
progressive condition like dry eye disease associated with
Meibomian gland dysfunction,” said Yehia Hashad, M.D., executive
vice president, Research & Development and chief medical
officer, Bausch + Lomb. “Excess tear evaporation is a major factor
in dry eye disease associated with Meibomian gland dysfunction,
which remains largely unaddressed.”
“Currently there are no FDA-approved prescription therapies
available which directly target evaporation, leaving patients with
limited treatment options,” said Christina Ackermann, president,
Ophthalmic Pharmaceuticals, Bausch + Lomb. “These data are
consistent with the results seen in the first Phase 3 trial, and
further support NOV03 as a new potential therapy designed to
alleviate the signs and symptoms of dry eye disease associated with
Meibomian gland dysfunction.”
DED affects millions of Americans and is one of the most common
ocular surface disorders.1 MGD is a major cause of development and
disease progression, affecting approximately nine out of 10 people
with DED.2,3 DED due to MGD is caused by a deficient tear film
lipid layer that leads to increased tear evaporation.4 There is
currently no approved prescription eye drop in the United States
indicated for DED associated with MGD.
“This is a year of exciting milestones for NOV03, with the
publication of both sets of pivotal Phase 3 data, anticipated new
topline data expected later this year from the KALAHARI 12 month
safety extension trial, and the PDUFA action date in June,” said
Christian Roesky, Ph.D., CEO, Novaliq. “We look forward to
continuing to work closely with Bausch + Lomb to advance NOV03 as a
potential new treatment option, which, if approved, will help to
address the needs of millions of Americans who suffer from dry eye
disease associated with Meibomian gland dysfunction.”
About the MOJAVE Study
The data from the Phase 3, multicenter, randomized, hypotonic
saline-controlled, double masked MOJAVE study was based on results
from 620 subjects aged 18 years and older who were randomized to
either receive treatment with NOV03 four times daily or hypotonic
saline solution four times daily (n=311 NOV03; n=309 saline).
The two primary endpoints were change from baseline at Week 8
(Day 57 ± 2) in total corneal fluorescein staining (tCFS) and eye
dryness Visual Analog Scale (VAS) score. Key secondary endpoints
included change from baseline in eye dryness VAS score and tCFS at
Week 2 (Day 15 ± 1) and eye burning/stinging VAS score and central
corneal fluorescein staining (cCFS) at Week 8. Significant
improvements vs. hypotonic saline solution were seen as early as
day 15. Data highlights include:
Primary endpoints
- At Week 8, reduction from baseline in tCFS was statistically
greater in the NOV03 arm compared to the control saline group
(least-squares [LS] mean treatment difference, -1.2 (95% confidence
interval [CI]: -1.7, -0.8) (P < .001)).
- At Week 8, VAS dryness score was statistically significantly
improved in the NOV03 arm compared to control group (LS mean
treatment difference, -10.2 (95% CI: -14.4, -6.1) (P <
.001)).
Key secondary endpoints
- At Week 2, tCFS and VAS dryness score were statistically
significant compared to saline, with an LS mean treatment
difference (95% CI) for change from baseline in tCFS of -0.6 (-1.0,
-0.2) (P = .001) and VAS score of -7.8 (-11.3, -4.3) (P <
.001).
- At Week 8 VAS burning/stinging score and cCFS also favored the
NOV03 group, with an LS mean treatment difference (95% CI) for
change from baseline in VAS burning/stinging score of -7.3 (-11.3,
-3.4) (P < .001) and cCFS of -0.3 (-0.5, -0.2) (P <
.001).
In the study, NOV03 was well tolerated with few subjects
experiencing ocular adverse events (AEs) (12.9% NOV03 group, 12.3%
control group) or treatment-related ocular AEs (6.4% NOV03 group,
6.8% control group). Most AEs were mild to moderate in severity.
The most common AEs (incidence ≥ 1%) experienced in the NOV03 group
were blepharitis, conjunctival hyperemia, conjunctival papillae,
ocular hyperemia, blurred vision, hordeolum (stye), and visual
acuity reduction. No patients in either the NOV03 group or saline
group had an ocular AE that led to treatment discontinuation or
withdrawal from the study.
About NOV03 (perfluorohexyloctane) Ophthalmic Solution
NOV03 is an investigational, proprietary, water-free,
single-component preservative-free eye drop.5 In 2019, Bausch +
Lomb acquired an exclusive license for the commercialization and
development of NOV03 in the United States and Canada. Results from
the pivotal Phase 2 trial (SEECASE) were published in Cornea in
September 2021. Data from the first pivotal Phase 3 trial (GOBI)
were presented at the American Society of Cataract and Refractive
Surgery (ASCRS) annual meeting in Washington, D.C. on April 24,
2022. Data from the second pivotal Phase 3 trial (MOJAVE) were
presented at the Association for Research in Vision and
Ophthalmology (ARVO) annual meeting in Denver on May 2, 2022. The
clinical program for NOV03 concluded with the completion of a
multi-center, open-label, single-arm, 12-month safety extension
trial (KALAHARI). In September 2022, Bausch + Lomb and NOV03
announced that the U.S. FDA had accepted the NDA filing for NOV03
and assigned a PDUFA action date of June 28, 2023.
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 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 approximately 13,000
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.
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 + Lomb’s 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 + Lomb, 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 + Lomb
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
- National Eye Institute. Dry Eye. Last updated April 8, 2022.
Accessed December 21, 2022.
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye
- Leonardi, A., Modugno, R. L., & Salami, E. (2021). Allergy
and Dry Eye Disease. Ocular immunology and inflammation, 29(6),
1168-1176. https://doi.org/10.1080/09273948.2020.1841804.
- Lemp, MA, Crews, LA, Bron AJ. (2012). Distribution of
Aqueous-Deficient and Evaporative Dry Eye in a Clinic-Based Patient
Cohort: a retrospective study. Cornea, 31(5), 472-478.
https://journals.lww.com/corneajrnl/Abstract/2012/05000/Distribution_of_Aqueous_Deficient_and_Evaporative.2.aspx
- Geerling G, Baudouin C, Aragona P, et al. (2017). Emerging
strategies for the diagnosis and treatment of meibomian gland
dysfunction: Proceedings of the OCEAN group meeting. The Ocular
Surface,15(2): 179-192.
https://doi.org/10.1016/j.jtos.2017.01.006
- 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.
All product/brand names and/or logos are trademarks of the
respective owners. © 2023 Bausch & Lomb Incorporated or its
affiliates. NOV03.0004.USA.23 V2
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Novaliq Media Contact: Simone Angstmann-Mehr
info@novaliq.com
Bausch + Lomb Investor Contacts: Arthur Shannon/Allison
Ryan arthur.shannon@bausch.com;allison.ryan@bausch.com (877)
354-3705 (toll free); (908) 927-0735
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(908) 927-0683
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