Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP), a clinical stage
biopharmaceutical company focused on the global immunology market, today
announced the initiation of its Phase 2 trial evaluating voclosporin
ophthalmic solution (VOS) for the treatment of dry eye syndrome (DES).
VOS, which is a proprietary nanomicellar formulation, enables high
concentrations of voclosporin to be incorporated into a clear aqueous,
preservative-free solution for local delivery to the ocular surface.
This patented formulation has the potential to result in improved
efficacy, dosing frequency, and tolerability versus the current
treatments for DES.
This Phase 2 study is evaluating the ocular tolerability of VOS 0.2%
versus Restasis® (cyclosporine ophthalmic emulsion 0.05%) at four weeks
in subjects with mild to moderate DES. This robust head-to-head trial is
recruiting 90 patients in sites across the United States, and the study
is expected to complete at the end of 2018. Key secondary endpoints
include Ocular Surface Disease Index (OSDI), System Assessment in Dry
Eye (SANDE), Individual Symptom Severity Assessments and Drop Discomfort
Visual Analog Scale (VAS) scores, Fluorescein Corneal Staining (FCS),
and Schirmer Tear Test (STT).
“Topical calcineurin inhibition is thought to be a mainstay of treatment
for dry eye, and based on its unique profile, we believe that VOS has
the potential to compete in the multi-billion-dollar prescription dry
eye market,” said Richard M. Glickman, Aurinia’s Chairman and Chief
Executive Officer. “Our goal with this program is to develop a
best-in-class treatment option, and upon completion, we will look to
evaluate strategic alternatives for this asset.”
VOS has demonstrated safety and tolerability in a human Phase Ib study
(n=35), supporting its development for the treatment of DES. It has also
previously shown evidence of efficacy in canine studies, which are being
conducted by Merck Animal Health.
Aurinia Pharmaceuticals is a clinical stage biopharmaceutical company
focused on developing and commercializing therapies to treat targeted
patient populations that are suffering from serious diseases with a high
unmet medical need. The company is currently developing voclosporin,
an investigational drug, for the potential treatment of lupus nephritis,
focal segmental glomerulosclerosis, and dry eye syndrome. The company is
headquartered in Victoria, British Columbia and focuses its development
efforts globally. For further information, see our website at www.auriniapharma.com.
About Voclosporin Ophthalmic Solution (VOS)
VOS is an aqueous, preservative free nanomicellar solution containing
0.2% voclosporin intended for use in the treatment of DES. Studies have
been completed in rabbit and dog models, and a single Phase I has also
been completed in healthy volunteers and patients with DES. VOS has IP
protection until 2031.
About Dry Eye Syndrome (DES)
Dry eye syndrome (DES) is characterized by irritation and inflammation
that occurs when the eye’s tear film is compromised by reduced tear
production, imbalanced tear composition, or excessive tear evaporation.
The impact of DES ranges from subtle, yet constant eye irritation to
significant inflammation and scarring of the eye’s surface. Discomfort
and pain resulting from DES can reduce quality of life and cause
difficulty reading, driving, using computers and performing daily
activities. DES is a chronic disease. There are currently two FDA
approved therapies for the treatment of dry eye; however, however there
remains a large opportunity to improve on efficacy and tolerability.
Certain statements made in this press release may constitute
forward-looking information within the meaning of applicable Canadian
securities law and forward-looking statements within the meaning of
applicable United States securities law. These forward-looking
statements or information include, but are not limited to statements or
information with respect to; the safety and tolerability of VOS; the
timing for commencement of a Phase 2 tolerability study of VOS; the
timing for completion of the Phase 2 tolerability study of VOS and
strategic considerations for this asset. It is possible that such
results or conclusions may change based on further analyses of these
data Words such as “anticipate”, “will”, “believe”, “estimate”,
“expect”, “intend”, “target”, “plan”, “goals”, “objectives”, “may” and
other similar words and expressions, identify forward-looking
statements. We have made numerous assumptions about the forward-looking
statements and information contained herein, including among other
things, assumptions about: the market value for the DES program; that
another company will not create a substantial competitive product for
Aurinia’s DES business without violating Aurinia’s intellectual property
rights; Even though the management of Aurinia believes that the
assumptions made, and the expectations represented by such statements or
information are reasonable, there can be no assurance that the
forward-looking information will prove to be accurate.
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