SOPHIA ANTIPOLIS, FRANCE and MADISON, NJ--(Marketwire - January 29, 2013) -
Bausch + Lomb Initiates Phase 3 Program for Glaucoma Drug Candidate
Bausch + Lomb, the global eye health company, and Nicox S.A.
(EURONEXT PARIS: COX) today announced that Bausch + Lomb has
initiated its Phase 3
clinical program of latanoprostene bunod (previously known as
NCX 116) for the reduction of intraocular pressure (IOP) in patients
glaucoma or ocular hypertension. Latanoprostene bunod is a nitric
prostaglandin F2-alpha analog licensed by Nicox to Bausch + Lomb.
This pivotal Phase 3 program includes two separate randomized,
double-masked, parallel-group clinical studies, APOLLO and LUNAR,
compare the efficacy and safety of latanoprostene bunod administered once
(QD) with timolol maleate 0.5% administered twice daily (BID) in lowering
patients with open-angle glaucoma or ocular hypertension. The primary
of both studies, which will include a combined total of approximately
patients, is the reduction in mean IOP measured at specified time points
three months of treatment. The Phase 3 studies are pivotal for U.S.
and will be conducted in North America and Europe. Additional information
the studies can be found at www.clinicaltrials.gov.
"There is a need for more effective, safer and better tolerated
lower IOP," said Robert N. Weinreb, M.D., chairman & distinguished
Ophthalmology, University of California San Diego and director,
Center and Hamilton Glaucoma Center. "The Phase 2b results for
bunod were promising, so it is exciting that this potential new
now in pivotal trials."
Bausch + Lomb's decision to proceed with a pivotal Phase 3 program
positive results with latanoprostene bunod in a Phase 2b trial in 413
with elevated IOP due to glaucoma and ocular hypertension. This study
that latanoprostene bunod consistently lowered IOP in a dose-dependent
All four doses tested in the Phase 2b trial showed greater IOP
compared with Xalatan® 0.005%, with the differences for two of the
reaching more than 1mmHg (statistical significance: p < 0.01).
"Bausch + Lomb believes that latanoprostene bunod has the potential to
important new treatment option for people suffering from elevated IOP
glaucoma and ocular hypertension," said Cal Roberts, M.D. executive
president and chief medical officer, Bausch + Lomb. "We look
completing this pivotal research program, and hope to develop an
treatment option to benefit physicians and the patients they serve."
"Latanoprostene bunod is a nitric oxide-donating compound which was
in our Research Laboratories in Milan and is the first Nicox program
a partner to enter into Phase 3," said Michele Garufi, chairman and
Nicox. "We are pleased with Bausch + Lomb's commitment to pursuing this
in an area of significant therapeutic need. The whole Nicox team has
to this important milestone which underlines the potential of our
platform in the ophthalmic field."
Nicox and Bausch + Lomb Worldwide Licensing Agreement
In March 2010, Bausch + Lomb signed a worldwide licensing agreement with
for latanoprostene bunod, and made an initial license payment of $10
light of the positive results of the Phase 2b study completed in 2011,
Lomb made an additional $10 million milestone payment in April 2012
their decision to pursue further development of latanoprostene bunod. If
regulatory, commercialization and sales milestones for latanoprostene
met, Nicox stands to receive from Bausch + Lomb additional potential
which, over time, could total $162.5 million. Nicox will also receive
double-digit royalties on the sales of latanoprostene bunod and has the
to co-promote the product in the United States.
Glaucoma is a group of eye diseases which can lead to the loss of
vision and eventually total blindness. Glaucoma is frequently
abnormally high pressure in the eye (intraocular pressure, IOP), due to
or malfunction of the eye's drainage system. Abnormally high IOP does not
any symptoms itself, however it can lead to optic nerve damage and vision
if left untreated. Drug therapy is used to reduce IOP and therefore
further vision loss, typically through increasing the drainage of
fluid by relaxing certain muscles in the eye. Several large trials
demonstrated that reducing IOP can prevent the progression of glaucoma in
early and late stages of the disease. A significant proportion of patients
elevated IOP require more than one medication to maintain their IOP
target levels, highlighting the need for more effective treatments.
About Bausch + Lomb
Bausch + Lomb is one of the best-known and most respected healthcare
in the world. Its core businesses include contact lenses and lens care
ophthalmic surgical devices and instruments, and ophthalmic
Founded in 1853, the company is headquartered in Rochester, NY, and
roughly 11,000 people worldwide. Its products are available in more than
countries. More information is available at www.bausch.com.
Nicox (Bloomberg: COX:FP, Reuters: NCOX.PA) is creating a new
international player in the ophthalmic market by building a
portfolio of innovative therapies and diagnostic tools. With a
scientific, business development and commercial expertise, the Nicox
focused on developing and marketing novel pharmaceuticals and diagnostic
that can help people to enhance their sight. In the United States, Nicox
AdenoPlus™, a test for the differential diagnosis of acute
in-licensed from RPS®.
The Company's pipeline includes latanoprostene bunod, a novel
based on Nicox's proprietary nitric oxide (NO)-donating R&D platform,
in collaboration with Bausch + Lomb for the potential treatment of
ocular hypertension. Further NO-donating compounds are under development in
non-ophthalmic indications, notably through partners, including Merck
(known as MSD
outside the United States and Canada) and Ferrer.
Nicox S.A. is headquartered in France and is listed on Euronext Paris
(Compartment B: Small Caps). For more information please visit
This press release contains certain forward-looking statements.
Company believes its expectations are based on reasonable assumptions,
forward-looking statements are subject to numerous risks and
which could cause actual results to differ materially from those
the forward-looking statements.
Risks factors which are likely to have a material effect on Nicox's
presented in the 4th chapter of the « Document de
référence, rapport financier
annuel et rapport de gestion 2011 » filed with the French
Autorité des Marchés
Financiers (AMF) on February 29, 2012 and available on Nicox's
(www.nicox.com) and on the AMF's website www.amf-france.org).
Bausch + Lomb - Nicox: Phase 3 Program Initiation:
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