MIEBO is the First and Only Prescription Eye
Drop Approved for Dry Eye Disease that Directly Targets Tear
Evaporation, Based on Consistent Results from Two Consecutive
Pivotal Phase 3 Trials
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 approved MIEBO™ (perfluorohexyloctane ophthalmic solution;
formerly known as NOV03), for the treatment of the signs and
symptoms of dry eye disease (DED). MIEBO is the first and only
FDA-approved treatment for DED that directly targets tear
evaporation.
“Today’s FDA approval of MIEBO further advances DED treatment by
addressing a significant unmet need for millions of people
suffering with this disease,” said Brent Saunders, chairman and
CEO, Bausch + Lomb. “We are proud to bring to market the first and
only prescription eye drop approved in the United States for the
treatment of DED that directly targets evaporation. We expect to
make MIEBO commercially available in the second half of this
year.”
DED affects millions of Americans and is one of the most common
ocular surface disorders.1 A leading cause of DED is excessive tear
evaporation, which due to an altered tear lipid layer, is often
associated with the clinical signs of Meibomian gland dysfunction
(MGD). An unstable tear film triggers increased ocular surface
desiccation, inflammation and damage to the ocular surface.2,3
MIEBO is designed to reduce tear evaporation at the ocular
surface.4,5
In GOBI and MOJAVE, two phase 3 pivotal clinical trials which
enrolled more than 1,200 patients (randomized 1:1 to MIEBO or
hypotonic saline) with a history of DED and clinical signs of MGD,
MIEBO consistently met its primary clinical sign and
patient-reported symptom endpoint.
"In the two pivotal clinical trials, MIEBO addressed the
persistent and chronic nature of DED by providing sustained
improvement in both the signs and symptoms of DED,” said Preeya
Gupta, M.D., cornea and cataract surgeon, Triangle Eye Consultants,
Raleigh, North Carolina. “Because MIEBO inhibits evaporation, it
may be an appropriate treatment option for patients whose tear
evaporation exceeds tear supply.”
“Tear evaporation, which is a leading driver of DED, presents a
significant treatment challenge. With the approval of MIEBO, eye
care professionals can now take a new approach to DED therapy with
a first-in-class water- and preservative-free prescription
treatment option that specifically addresses tear evaporation,”
said Paul Karpecki, O.D., director, Cornea and External Disease,
Kentucky Eye Institute, and associate professor, University of
Pikeville, Kentucky College of Optometry.
MIEBO Clinical Data
The FDA approval of MIEBO™ was based on results from two 57-day,
multi-center, randomized, double-masked, saline-controlled studies,
GOBI and MOJAVE, which enrolled a total of 1,217 patients with a
history of DED and clinical signs of MGD,6,7 a major cause of
development and disease progression.8 An estimated 86% of people
with DED have excessive tear evaporation whereby MGD is the major
contributor.9,10
In the GOBI and MOJAVE phase 3 pivotal studies, MIEBO met both
primary sign and symptom efficacy endpoints. The two primary
endpoints were change from baseline at week eight (day 57 ± 2) in
total corneal fluorescein staining (tCFS) and eye dryness Visual
Analog Scale (VAS) score. Patients experienced relief of symptoms
as early as day 15 and through day 57 with statistically
significant reduction in VAS eye dryness score favoring MIEBO
observed in both studies. Additionally, at days 15 and day 57, a
significant reduction in tCFS favoring MIEBO was observed in both
studies.
The most common adverse reactions experienced with MIEBO were
blurred vision (1.3-3%) and eye redness (1-3%).
Additional Executive Commentary
“Today’s FDA decision marks a tremendous milestone for Bausch +
Lomb as MIEBO becomes our first prescription pharmaceutical eye
treatment to be approved by the FDA since becoming an independent,
publicly traded eye health company,” said Andrew Stewart,
president, Ophthalmic Pharmaceuticals, Bausch + Lomb. “We are proud
to further deliver on our promise to bringing innovative new
options to help patients improve their treatment journey.”
“Bausch + Lomb is deeply committed to bringing forward medicines
that address unmet medical needs, and MIEBO is a prime example of
this commitment being realized,” said Yehia Hashad, M.D., executive
vice president, Research & Development and chief medical
officer, Bausch + Lomb. “We are extremely grateful to all of our
collaborators, including trial patients, clinical investigators and
our R&D team, for their tireless contributions to this
important milestone.”
“We believe that MIEBO will address a significant unmet need for
the many Americans who struggle with evaporative dry eye,” said
Christian Roesky, Ph.D., CEO, Novaliq. “We are grateful to Bausch +
Lomb for their continued collaboration in bringing this unique new
treatment option to market.”
INDICATION
MIEBO™ (perfluorohexyloctane ophthalmic solution) is used to
treat the signs and symptoms of dry eye disease.
IMPORTANT SAFETY INFORMATION
- Patients should remove contact lenses before using MIEBO™ and
wait for at least 30 minutes before reinserting.
- It is important for patients to use MIEBO exactly as
prescribed.
- It is not known if MIEBO™ is safe and effective in children
under the age of 18.
- The most common eye side effect seen in studies was blurred
vision (1% to 3 % of patients reported blurred vision and eye
redness).
Patients are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Click here for full Prescribing Information for
MIEBO.
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 May 2, 2023.
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/dry-eye
- Craig JP, Nelson JD, Azar DT, et al. TFOS DEWS II report
executive summary. Ocul Surf. 2017;15(4):802-812.
doi:10.1016/j.jtos.2017.08.003
- Pflugfelder SC, Paiva CS. The pathophysiology of dry eye
disease: what we know and future directions for research.
Ophthalmology. 2017;124(suppl 11):S4-S13.
doi:10.1016/j.ophtha.2017.07.010
- Nichols KK, Foulks GN, Bron AJ, et al. The international
workshop on Meibomian gland dysfunction: executive summary. Invest
Ophthalmol Vis Sci. 2011;52(4):1922-1929.
doi:10.1167/iovs.10-6997a
- Borchman D, Vittitow J, Ewurum A, Veligandl SR. Spectroscopic
study of perfluorohexyloctane human Meibum interactions. Invest
Ophthalmol Vis Sci. 2022;63:1525.
- Tauber J, Berdy GJ, Wirta DL, et al. NOV03 for dry eye disease
associated with meibomian gland dysfunction: Results of the
Randomized Phase 3 GOBI Study. Ophthalmology. 2023;130(5):516-524.
doi:10.1016/j.ophtha.2022.12.021
- Sheppard J, Kurata F, Epitropoulos AT, et al. NOV03 for signs
and symptoms of dry eye disease associated with meibomian gland
dysfunction: The randomized phase 3 Mojave study. American Journal
of Ophthalmology. Published online ahead of print. March 20 2023.
doi:10.1016/j.ajo.2023.03.008
- Chhadva P, Goldhardt R, Galor A. Meibomian Gland Disease: The
Role of Gland Dysfunction in Dry Eye Disease. Ophthalmology.
2017;124(11S):S20-S26. doi:10.1016/j.ophtha.2017.05.031
- Findlay, Q., & Reid, K. (2018). Dry eye disease: when to
treat and when to refer. Australian prescriber, 41(5), 160-163.
https://doi.org/10.18773/austprescr.2018.048
- 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.
2012;31(5):472-478. doi:10.109/ICO.0b013e318225415a.
© 2023 Bausch + Lomb. NOV03.0010.USA.23
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