Market Overview

Sun Pharma Announces U.S. FDA Approval of CEQUA™ to Treat Dry Eye Disease

Share:

CEQUA (cyclosporine ophthalmic solution) 0.09% for topical ophthalmic
use is the first and only dry eye treatment to combine cyclosporine A
with nanomicellar technology

Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN,
NSE:SUNPHARMA, BSE:524715, "Sun Pharma" and includes its subsidiaries
and/or associate companies) today announced that Sun Pharma has received
approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the
U.S. Food and Drug Administration (FDA). CEQUA is indicated to increase
tear production in patients with keratoconjunctivitis sicca (dry eye).

CEQUA provides the highest FDA-approved concentration of cyclosporine A
(CsA) and is the first and only approved CsA product that incorporates a
nanomicellar technology. The innovative nanomicellar formulation allows
the CsA molecule to overcome solubility challenges, penetrate the eye's
aqueous layer and prevents the release of the active lipophilic molecule
prior to penetration. In the Phase 3 confirmatory trial on CEQUA, after
12 weeks of treatment, as compared to vehicle, CEQUA showed
statistically significant improvement in the primary endpoint,
Schirmer's score (a measurement of tear production) (p<0.01).
Improvements in secondary endpoints (i.e. ocular staining assessments)
were seen as early as 1 month after initiating treatment. CEQUA is dosed
twice daily and will be available as a single-use vial.

The nanomicellar formulation technology uses micelles, which are
gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic)
molecules formed at a well-defined concentration. The small size of the
nanomicelles facilitates entry into corneal and conjunctival cells,
enabling delivery of high concentrations of CsA.

"Dry Eye Disease represents an area of high unmet medical need, with a
significant number of patients who are currently untreated," said Abhay
Gandhi, CEO, North America, Sun Pharma. "The U.S. FDA approval of CEQUA
represents a long-awaited dry eye treatment option and is an important
milestone in the development of Sun's Ophthalmics business. CEQUA, with
its novel nanomicellar formulation for a proven dry eye medication,
delivers a lipophilic molecule in a clear solution form."

Additionally, Jodi Luchs, MD, the principal investigator behind the
CEQUA confirmatory Phase 3 trial, noted: "Dry eye is a complex disease
that lacks a ‘one-size-fits-all' approach. As a clinician treating a
high volume of dry eye patients, it's important to have multiple
treatment modalities available at my disposal. Given its strong clinical
trial performance, the approval of CEQUA is welcomed news, and I look
forward to offering my patients this compelling new option."

CEQUA (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic
use will be commercialized in the U.S. by Sun Ophthalmics, the branded
ophthalmics division of Sun Pharma's wholly owned subsidiary.

About CEQUA™

CEQUA (cyclosporine A, ophthalmic solution) is a patented, novel,
proprietary nanomicellar formulation of cyclosporine A, 0.09% in a
clear, preservative-free, aqueous solution. In a multicentered,
randomized, double-masked, vehicle-controlled Phase 3 confirmatory
study, 744 patients with dry eye were treated either with CEQUA or its
vehicle. After 12 weeks of treatment, as compared to vehicle, CEQUA
showed statistically significant improvement in the primary end point,
Schirmer's score (a measurement of tear production) (p<0.01).
Additionally, several key secondary endpoints showed statistically
significant improvements compared to vehicle, with some showing
improvement as early as 1 month following treatment. Adverse events
reported in the trial were mostly mild in nature. In a prior Phase 2b/3
clinical trial with 455 patients, CEQUA demonstrated increased tear
production (p<0.01) and was well tolerated by the study population.
Additionally, several key secondary endpoints showed statistically
significant improvements compared to vehicle. The most common adverse
reaction following the use of cyclosporine ophthalmic solution 0.09% was
instillation site pain (22%) and conjunctival hyperemia (6%). Other
adverse reactions reported in 1% to 5% of the patients were eye
irritation, blepharitis urinary tract infection, headache, and
bronchitis.

INDICATIONS AND USAGE
CEQUA (cyclosporine ophthalmic
solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated
to increase tear production in patients with keratoconjunctivitis sicca
(dry eye).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Potential for Eye Injury and Contamination: To avoid the
potential for eye injury and contamination, advise patients not to touch
the vial tip to the eye or other surfaces.

Use with Contact Lenses: CEQUA should not be administered while
wearing contact lenses. If contact lenses are worn, they should be
removed prior to administration of the solution. Lenses may be
reinserted 15 minutes following administration of CEQUA ophthalmic
solution.

ADVERSE REACTIONS
The most common adverse reactions reported
in greater than 5% of patients were pain on instillation of drops (22%)
and conjunctival hyperemia (6%). Other adverse reactions reported in 1%
to 5% of patients were blepharitis, eye irritation, headache, and
urinary tract infection.

Please click for Full
Prescribing Information
& for more information visit CEQUA.com

About Dry Eye Disease

Dry eye is a burdensome, chronic disease affecting millions of patients
around the world, with a significant population, greater than 16 million
patients, present in the United States.

Dry eye disease, as defined by the National Eye Institute (NEI, a
division of the U.S. National Institutes of Health [NIH]), occurs when
the quantity and/or quality of tears fails to keep the surface of the
eye properly lubricated. The disease causes a scratchy sensation or a
feeling that something is in the eye. Other symptoms include stinging or
burning, episodes of excess tearing following periods of stress,
discharge, pain, and redness in the eye. The risk of developing dry eye
increases with advancing age, and is more common in women than in men.

TM - All brand names and trademarks are the property of respective
owners.

Disclaimer:

Statements in this "Document" describing the Company's objectives,
projections, estimates, expectations, plans or predictions or industry
conditions or events may be "forward looking statements" within the
meaning of applicable securities laws and regulations. Actual results,
performance or achievements could differ materially from those expressed
or implied.

About Sun Ophthalmics

Backed by Sun Pharma's global expertise in R&D, Sun Ophthalmics (the
branded ophthalmics division of Sun Pharma's wholly owned subsidiary) is
leading the way through the development of innovative products and in
partnership with eye care professionals. Sun Ophthalmics markets BromSite®
(bromfenac ophthalmic solution) 0.075% in the U.S. Other candidates in
Sun Ophthalmics' development pipeline include Xelpros™ (latanoprost
ophthalmic solution) 0.005% and DexaSite™ (dexamethasone) 0.1%. Sun
Ophthalmics' dedicated team is focused solely on the needs of eye care
professionals, offering timely, knowledgeable support at every turn. The
company strives to deliver products built on unique platforms that
integrate seamlessly into the eye care practice, helping eye care
professionals to continue providing quality medicine. Discover a
brighter future in eye care at www.sunophthalmics.com.

About Sun Pharmaceutical Industries Ltd. (CIN -
L24230GJ1993PLC019050):

Sun Pharma is the world's fifth largest specialty generic pharmaceutical
company and India's top pharmaceutical company. A vertically integrated
business, economies of scale and an extremely skilled team enable us to
deliver quality products in a timely manner at affordable prices. It
provides high-quality, affordable medicines trusted by customers and
patients in over 150 countries across the world. Sun Pharma's global
presence is supported by 41 manufacturing facilities spread across 6
continents, R&D centres across the globe and a multi-cultural workforce
comprising over 50 nationalities. In India, the company enjoys
leadership across 13 different classes of doctors with 32 brands
featuring amongst top 300 pharmaceutical brands in India. Its footprint
across emerging markets covers over 100 markets and 6 markets in Western
Europe. Its Global Consumer Healthcare business is ranked amongst Top 10
across 3 global markets. Its API business footprint is strengthened
through 14 world class API manufacturing facilities across the globe.
Sun Pharma fosters excellence through innovation supported by strong R&D
capabilities comprising about 2,000 scientists and R&D investments of
approximately 8% of annual revenues. For further information, please
visit www.sunpharma.com
& follow us on Twitter @SunPharma_Live.

View Comments and Join the Discussion!