LAVAL, Quebec and SOPHIA
ANTIPOLIS, France, Nov. 2, 2017 /PRNewswire/ -- Valeant
Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX)
wholly owned subsidiary, Bausch + Lomb, a leading global eye health
company, and Nicox S.A. (Euronext Paris: FR0013018124, COX), an
international ophthalmic company, today announced that the U.S.
Food and Drug Administration (FDA) has approved the New Drug
Application (NDA) for VYZULTA™ (latanoprostene bunod ophthalmic
solution, 0.024%). VYZULTA, the first prostaglandin analog with one
of its metabolites being nitric oxide (NO), is indicated for the
reduction of intraocular pressure (IOP) in patients with open-angle
glaucoma or ocular hypertension.1
"With today's approval of VYZULTA, our customers and their
patients with glaucoma now have a new treatment option that can
help provide consistent and sustained IOP lowering, the only
modifiable risk factor that can help slow down the progression of
the disease," said Joseph C. Papa,
chairman and CEO, Valeant. "We expect to make this new advancement
available for those who suffer with glaucoma before the end of the
year."
Following topical administration, VYZULTA, a once daily
monotherapy with a dual mechanism of action, works by metabolizing
into two moieties, latanoprost acid, which primarily works within
the uveoscleral pathway to increase aqueous humor outflow, and
butanediol mononitrate, which releases NO to increase outflow
through the trabecular meshwork and Schlemm's canal. The most
common ocular adverse events include conjunctival hyperemia, eye
irritation, eye pain and instillation site pain. Increased
pigmentation of the iris and periorbital tissue and growth of
eyelashes can occur.
In glaucoma patients, damage to the trabecular meshwork, through
which the majority of the aqueous humor passes, can lead to reduced
drainage and as a result elevated IOP. Lowering IOP, even in
patients with normal baseline levels, can delay, or even prevent
damage to optic nerves, helping to reduce the risk of glaucomatous
visual field loss.
"VYZULTA represents the first FDA-approved therapy developed
through our proprietary NO-donating research platform," said
Michele Garufi, chairman and CEO of
Nicox. "We look forward to continuing to leverage our platform in
the development of additional innovative ophthalmic compounds."
Preclinical studies have shown that NO plays a role in
controlling IOP in normal eyes by increasing aqueous humor outflow
through the trabecular meshwork and Schlemm's canal. Studies have
also demonstrated that patients with glaucoma have reduced levels
of NO signaling in their eyes, providing a rationale for the
therapeutic value of NO-releasing molecules for patients with
open-angle glaucoma or ocular hypertension.
"The safety and efficacy of VYZULTA has been well-established
through multiple clinical studies, which have demonstrated positive
results, including statistically significant differences in IOP
lowering compared to timolol and latanoprost," said Robert N. Weinreb, M.D., chairman and
distinguished professor of Ophthalmology and director, Hamilton
Glaucoma Center at the University of
California San Diego. "As one molecule with a dual
mechanism of action, VYZULTA™ provides a new treatment option that
works to reduce IOP by increasing the outflow through both the
trabecular meshwork and the uveoscleral pathways."
VYZULTA was licensed on a global basis to Bausch + Lomb from
Nicox. As a result of this approval, Nicox will receive
$17.5 million from Bausch + Lomb and
will make a $15 million payment to
Pfizer under a previous license agreement.
VYZULTA™ COMPREHENSIVE CLINICAL TRIALS
VYZULTA™ vs. Timolol Study: Non-Inferior & Superior to
Timolol 0.5% (32% Mean Diurnal IOP Reduction)
The efficacy
and safety of VYZULTA were evaluated in two randomized,
multi-center, double-masked, parallel-group Phase 3 studies, APOLLO
and LUNAR, comparing VYZULTA with timolol maleate ophthalmic
solution 0.5% in subjects (N=831) with open-angle glaucoma or
ocular hypertension. The primary objective of these studies was to
demonstrate that the mean IOP reduction over 3 months of treatment
with VYZULTA once daily (QD) in the evening was non-inferior to
timolol 0.5% twice daily (BID). A secondary objective was to
demonstrate the superiority of VYZULTA QD to timolol 0.5% BID. In
both studies, VYZULTA met the primary efficacy endpoint. VYZULTA
also demonstrated significantly greater IOP lowering than timolol
0.5% throughout the day at 3 months of treatment resulting in a
reduction in mean diurnal IOP of 32% from baseline.2,3,4
The most common ocular adverse events included conjunctival
hyperemia (6%), eye irritation (4%), eye pain (3%), and
instillation site pain (2%).1 No unexpected safety
concerns were raised as a result of any of the ocular sign
assessments or vital sign measurements.2,3
VYZULTA™ vs. Latanoprost Study: Greater Mean IOP Reduction
vs. Latanoprost
In the Phase 2 VOYAGER study, designed to
identify the appropriate dose of VYZULTA for the reduction of IOP
in addition to assessing safety and efficacy, 413 patients across
23 sites in the United States and
Europe were randomized to receive
either latanoprostene bunod (various concentrations) or Xalatan
(latanoprost ophthalmic solution 0.005%) once a day in the evening
for 28 days. Two of the four doses tested, including the FDA
approved dose for VYZULTA (latanoprostene bunod ophthalmic
solution), 0.024%, showed greater IOP reduction compared with
Xalatan (latanoprost ophthalmic solution 0.005%), with the
differences reaching 1.23 mm Hg (p=0.005) for VYZULTA.
In addition, 68.7% of subjects treated with the FDA approved dose
for VYZULTA (latanoprostene bunod ophthalmic solution), 0.024%,
compared to 47.5% of subjects treated with Xalatan (latanoprost
ophthalmic solution 0.005%), achieved a mean diurnal IOP ≤18 mm Hg
(p<0.05).5
52-Week Safety Study: VYZULTA™ Reduced Mean IOP to 14.4
mm Hg in Subjects with Mean Low Baseline IOP of 19.6 mm
Hg
The long-term safety of VYZULTA was assessed in JUPITER,
a single-arm, multicenter, open-label Phase 3 study of one-year
duration in Japanese subjects (N=130) with open-angle glaucoma
(including normotensive, pigmentary and pseudoexfoliative glaucoma)
or ocular hypertension. The efficacy endpoints of the JUPITER study
were to evaluate the absolute IOP level and its reduction from
baseline over a 52-week period. The mean baseline IOP in the study
eye in the JUPITER study was 19.6 mm Hg. Treatment with VYZULTA
resulted in a 22% mean reduction in IOP at Week 4 which was
sustained through Week 52. Mean IOP was 14.4 mm Hg at Week 52
representing a 26% reduction from baseline in the study
eye.6 The most common ocular adverse events were
conjunctival hyperemia, growth of eyelashes, iris pigmentation,
blepharal pigmentation, eye irritation, and eye pain.
24-hour IOP Lowering Study: VYZULTA Demonstrated Better
24-hour IOP Control than Timolol
Another study,
CONSTELLATION, compared the effect of VYZULTA dosed QD with timolol
maleate ophthalmic solution 0.5% dosed BID in reducing IOP measured
over a 24-hour period in subjects with open-angle glaucoma or
ocular hypertension (N=25). The results of this randomized,
single-center, open-label, 2-month crossover study demonstrated
that VYZULTA lowered IOP over 24-hours, with a significantly
greater nocturnal IOP reduction vs. timolol
(p<0.004). The study also compared ocular perfusion
pressure (OPP) in VYZULTA-treated subjects vs. timolol-treated
subjects over a 24-hour period. VYZULTA improved daytime OPP vs.
baseline (p<0.001) and nocturnal OPP vs. timolol 0.5%
(p=0.01).7
Important Risk Information about VYZULTA
INDICATION AND USAGE
VYZULTA™ (latanoprostene
bunod ophthalmic solution), 0.024% is a prostaglandin analog
indicated for the reduction of intraocular pressure in patients
with open-angle glaucoma or ocular hypertension.
IMPORTANT SAFETY INFORMATION
- Increased pigmentation of the iris, periorbital tissue
(eyelid), and eyelashes can occur. Iris pigmentation is likely to
be permanent
- Gradual changes to eyelashes, including increased length,
increased thickness, and number of eyelashes, may occur. These
changes are usually reversible upon treatment discontinuation
- Most common ocular adverse reactions with incidence ≥2% are
conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%),
and instillation site pain (2%)
Please see full prescribing information at www.bausch.com.
About Nicox
Nicox S.A. (Euronext Paris: FR0013018124, COX) is an international
ophthalmic company developing innovative solutions to help maintain
vision and improve ocular health. By leveraging its proprietary
expertise in NO donation and other technologies, the Company is
developing an extensive portfolio of novel drug candidates that
target multiple ophthalmic conditions, including glaucoma. Nicox
currently has two products with approved NDAs, VYZULTATM
(latanoprostene bunod ophthalmic solution), 0.024%, licensed
worldwide to Bausch + Lomb, and ZERVIATETM (cetirizine
ophthalmic solution) 0.24% licensed in the U.S. to Eyevance. In
addition, its promising drug-candidate pipeline includes clinical
stage assets based both on its proprietary NO-donating research
platform and on the repurposing of existing molecules as well as a
next-generation of stand-alone NO donors and exploratory novel
NO-donating compounds with the potential to offer novel approaches
to treat a range of ophthalmic conditions. Nicox is headquartered
in Sophia Antipolis, France, is
listed on Euronext Paris (Compartment B: Mid Caps; Ticker symbol:
COX) and is part of the CAC Healthcare, CAC Pharma & Bio and
Next 150 indexes. For more information on Nicox, its products or
pipeline, please visit: www.nicox.com.
About Bausch + Lomb
Bausch + Lomb, a Valeant
Pharmaceuticals International, Inc. company, is a leading global
eye health organization that is solely focused on protecting,
enhancing and restoring people's eyesight. Its core businesses
include over-the-counter 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 our industry, which is available in more than 100
countries.
About Valeant
Valeant Pharmaceuticals International,
Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical
company that develops, manufactures and markets a broad range of
pharmaceutical products primarily in the areas of dermatology,
gastrointestinal disorders, eye health, neurology and branded
generics. More information about Valeant can be found at
www.valeant.com.
Forward-looking Statements
This press 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," "will,"
"believes," "estimates," "potential," "target," or "continue" and
variations or similar expressions. These statements are based upon
the current expectations and beliefs of the management of Valeant
and Nicox 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, risks and
uncertainties discussed in Valeant's most recent annual or
quarterly report and detailed from time to time in Valeant's other
filings with the Securities and Exchange Commission and the
Canadian Securities Administrators, which factors are incorporated
herein by reference. 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.
Neither Valeant nor Nicox undertakes any obligation to update any
of these forward-looking statements to reflect events or
circumstances after the date of this press release or to reflect
actual outcomes, unless required by law.
References
1. Vyzulta™ [prescribing information].
Bridgewater, NJ: Bausch & Lomb
Incorporated; 2017.
2. Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J.
Latanoprostene bunod 0.024% versus Timolol maleate 0.5% in subjects
with open-angle glaucoma or ocular hypertension: the APOLLO study.
Ophthalmology. 2016;123(5):965-973.
3. Medeiros FA, Martin KR, Peace J, et al. Comparison of
latanoprostene bunod 0.024% and timolol maleate 0.5% in open-angle
glaucoma or ocular hypertension: the LUNAR study. Am J
Ophthalmol. 2016;168:250-259.
4. Kaufman PL. Latanoprostene bunod ophthalmic solution 0.024% for
IOP lowering in glaucoma and ocular hypertension. Expert Opin
Pharmacother. 2017;18(4):433-444.
5. Weinreb RN, Ong T, Scassellati Sforzolini B, et al. A
randomised, controlled comparison of latanoprostene bunod and
latanoprost 0.005% in the treatment of ocular hypertension and open
angle glaucoma: the VOYAGER study. Br J Ophthalmol.
2015;99:738-745.
6. Kawase K, Vittitow JL, Weinreb RN, Araie M for the Jupiter Study
Group. Long-term safety and efficacy of latanoprostene bunod 0.024%
in Japanese subjects with open-angle glaucoma or ocular
hypertension: the JUPITER Study. Adv
Ther. 2016;33:1612-1627.
7. Liu J, Slight JR, Vittitow JL, et al. Efficacy of latanoprostene
bunod 0.024% compared with timolol 0.5% in lowering intraocular
pressure over 24 hours. Am J Ophthalmol.
2016;169:249-257.
Contact Information:
Valeant
Investor Relations:
Arthur Shannon
arthur.shannon@valeant.com
514-856-3855
877-281-6642 (toll free)
Media:
Lainie Keller
lainie.keller@valeant.com
908-927-0617
Kristy
Marks
kristy.marks@bausch.com
908-927-0683
Nicox S.A.
Investor Relations:
Europe
Gavin Spencer
Executive Vice President Corporate Development, Nicox
+33 (0)4-97-24-53-00
communications@nicox.com
United States
Argot Partners
Melissa Forst
212-600-1902
melissa@argotpartners.com
Media:
United Kingdom
Jonathan Birt
+44 7860 361 746
jonathan.birt@ymail.com
France
NewCap
Nicolas Merigeau
T +33 (0)1 44 71 94 98
nicox@newcap.eu
United States
Argot Partners
Eliza Schleifstein
917-763-8106
eliza@argotpartners.com
SOURCE Valeant Pharmaceuticals International, Inc.