PDUFA Action Date is June 28, 2023
VAUGHAN,
Ontario and HEIDELBERG,
Germany, Sept. 6,
2022 /PRNewswire/ -- 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 the U.S.
Food and Drug Administration (FDA) has accepted the New Drug
Application (NDA) filing for investigational treatment NOV03
(perfluorohexyloctane). A potential first-in-class eye drop with a
novel mechanism of action, NOV03 is an investigational therapy to
treat the signs and symptoms of dry eye disease (DED) associated
with Meibomian gland dysfunction (MGD). NOV03 has been assigned a
Prescription Drug User Fee Act (PDUFA) action date of June 28, 2023.
"With the FDA commencing review of the NDA filing, we are one
step closer to bringing an important new treatment option to the
millions of Americans affected by dry eye disease associated with
Meibomian gland dysfunction," said Joseph
C. Papa, CEO, Bausch + Lomb. "NOV03 is distinct from
anti-inflammatory and immunomodulatory agents, and, if approved,
would be the first prescription eye drop to address excessive tear
evaporation. The approval would also mark a significant milestone
for Bausch + Lomb, as the company's first FDA approval for a
prescription medicine since becoming a publicly traded company
earlier this year."
DED is one of the most common ocular surface disorders, with MGD
as a major cause of development and progression, affecting
approximately nine out of 10 people with DED.1,2 DED due
to MGD is caused by a deficient tear film lipid layer that leads to
increased tear evaporation.3 There is currently no
approved prescription eye drop in the
United States for DED associated with MGD.
"We are thrilled the FDA has accepted our NDA filing for NOV03,"
said Christian Roesky, Ph.D., CEO,
Novaliq. "With only limited treatment options currently available,
NOV03 is a promising potential new therapy, specifically designed
to alleviate the signs and symptoms of dry eye disease associated
with Meibomian gland dysfunction."
The clinical development program for NOV03 includes two Phase 3
studies (GOBI and MOJAVE), both of which demonstrated statistically
significant improvement vs. control for both primary and key
secondary sign and symptom endpoints as early as day 15 and through
day 57. NOV03 was well tolerated in both studies.
About NOV03 (perfluorohexyloctane) Ophthalmic
Solution
NOV03 (perfluorohexyloctane) is an investigational,
proprietary, water-free, non-steroidal, single-component
preservative-free eye drop.4 In 2019, Bausch + Lomb
acquired an exclusive license for the commercialization and
development of NOV03 in the United
States and Canada. 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. Results from the pivotal Phase 2
trial (SEECASE) were published in Cornea in September 2021.5 The clinical program
for NOV03 concluded with the completion of a multi-center,
open-label, single-arm, 12-month safety extension trial
(KALAHARI).
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 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.
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
- 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, M. A., Crews, L. A., Bron, A. J., Foulks, G. N., &
Sullivan, B. D. (2012). Distribution of aqueous-deficient and
evaporative dry eye in a clinic-based patient cohort: a
retrospective study. Cornea, 31(5), 472–478.
https://doi.org/10.1097/ICO.0b013e318225415a
- 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 + Lomb
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. (2021). A randomized clinical study
(SEECASE) to assess efficacy, safety, and tolerability of NOV03 for
treatment of dry eye disease. Cornea;40(9):1132-1140.
http://doi.org/10.1097/ICO.0000000000002622.
All product/brand names and/or logos are trademarks of the
respective owners.
© 2022 Bausch & Lomb Incorporated or its
affiliates.
NOV03.0016.USA.22
Novaliq Media
Contact:
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Bausch + Lomb Investor
Contacts:
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Simone
Angstmann-Mehr
|
Arthur Shannon/Allison
Ryan
|
info@novaliq.com
|
arthur.shannon@bausch.com;allison.ryan@bausch.com
|
|
(877) 354-3705 (toll
free); (908) 927-0735
|
|
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Bausch + Lomb Media Contacts:
|
|
Lainie Keller/Kristy
Marks
|
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lainie.keller@bausch.com;kristy.marks@bausch.com
|
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(908) 927-1198; (908)
927-0683
|
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SOURCE Bausch + Lomb Corporation