(Conference Call Scheduled for today, July 26, 2017 at 8:00 a.m. ET)
- Stargardt Disease Clinical Trial Planned to Start Before the End of
this Year -
- Focus on Multiple Orphan Programs in Retinal Diseases and Continue
Age-related Retinal Programs -
- Business Development Efforts Ongoing -
NEW YORK--(BUSINESS WIRE)--
Ophthotech Corporation (Nasdaq:OPHT) today announced that the Company is
pursuing a strategy to leverage its clinical experience and retina
expertise to identify and develop therapies to treat multiple orphan
ophthalmic diseases for which there are limited or no treatment options
available. In parallel, the Company continues its ongoing age-related
retinal programs and its business development efforts to obtain rights
to additional products, product candidates and technologies to treat
ophthalmic diseases, particularly those of the back of the eye. Call-in
and webcast information is provided below for a discussion of the
Company's financial and operating results and a business update.
-
Ophthotech's orphan ophthalmic disease strategy will be led by a
randomized, controlled clinical trial assessing the efficacy and
safety of Zimura® (avacincaptad pegol), the Company's C5
complement inhibitor, for Stargardt disease, a devastating inherited
retinal orphan disease causing vision loss during childhood or
adolescence for which patients have no approved treatment. This trial
is scheduled to start by the end of this year.
-
The Company is continuing its programs in age-related eye diseases,
including the planned initiation of a Phase 2a clinical trial of Zimura®
in combination with anti-VEGF therapy for wet age-related macular
degeneration (AMD) and a Phase 2a clinical trial of Zimura®
in combination with anti-VEGF therapy for idiopathic polypoidal
choroidal vasculopathy. Both of these trials are scheduled to start by
the end of this year.
-
The Company's Phase 2/3 clinical trial of Zimura® as a
monotherapy for the treatment of geographic atrophy, a form of dry
AMD, is ongoing. The Company has maintained a limited number of trial
sites for this study and will re-assess its strategy for this study
following results of a competitor's complement trial for geographic
atrophy, which are expected by year end.
-
The National Eye Institute is leading a Phase 1/2 clinical trial of
the Company's drug candidate, Fovista® (pegpleranib) in
combination with anti-VEGF therapy for the treatment of retinal
manifestations of the orphan disease Von Hippel-Lindau Syndrome.
-
Ophthotech is also planning a Phase 2a clinical trial of Zimura®
for intermediate/posterior non-infectious uveitis, a rare inflammatory
disease of the back of the eye, and a potential pre-clinical program
with Fovista® for retinoblastoma, a rare cancer of the eye
in children. These studies are planned to start in 2018.
"We are excited to move the Company forward with a goal of becoming a
leader in the development and commercialization of ophthalmic
therapeutics for orphan diseases and for larger indications in the back
of the eye, such as age-related retinal diseases," stated Glenn P.
Sblendorio, Chief Executive Officer and President of Ophthotech. "We
believe that we will be well positioned as a company with multiple shots
on goal to bring ophthalmic therapeutics to market. We are also
continuing our business development efforts with the goal of broadening
and advancing our pipeline. We are committed to developing treatments
for patients with devastating ophthalmic diseases and to maximizing
value for our shareholders."
Supporting the Company's strategy for the development of Zimura® in
Stargardt disease is a recently published independent, peer-reviewed
paper in the prestigious journal of Proceedings of National Academy
of Science (PNAS) from a world-class laboratory at the University of
California, Los Angeles (UCLA) that highlights the potential role of
complement inhibition in addressing the urgent unmet medical need in
Stargardt disease. Additionally, independent literature also supports
the scientific evidence for the potential role of complement and
specifically the membrane attack complex (MAC) in this disease. The
clinical safety data for Zimura® from the Company's completed
early stage age-related macular degeneration trials provide a basis to
proceed directly to a randomized, controlled clinical trial to assess
the safety and efficacy of Zimura® in Stargardt disease.
The Company also announced that it has entered into an agreement with
the Foundation Fighting Blindness (FFB). FFB is a highly-distinguished
organization recognized for its scientific commitment to orphan
inherited retinal degenerative diseases with an established network of
scientists and a robust patient registry. Ophthotech has engaged FFB to
provide the Company with information from its publicly available
ProgStar study, the largest natural history study on Stargardt disease
to date, which Ophthotech plans to use in the design of its planned
clinical trial of Zimura® for Stargardt disease, and to
potentially assist with the Company's other orphan degenerative retinal
programs.
"We commend Ophthotech for recognizing the underserved patients
afflicted with Stargardt disease for whom currently there is no
available FDA approved treatment option," stated Patricia Zilliox,
Ph.D., FFB's Clinical Research Institute Chief Drug Development Officer.
"We are delighted and honored to team up with Ophthotech thereby
complementing their expertise in ophthalmic drug development with our
experience in studying Stargardt disease."
"We are fortunate to have the opportunity to work closely with the
Foundation Fighting Blindness," stated Kourous A. Rezaei, M.D., Senior
Vice President of Medical Strategy. "We also intend to work closely with
the FDA over the next few months to discuss the regulatory pathway for
our Zimura® Stargardt program."
The Company also announced changes to its wet AMD program for Zimura®.
The Company believes that supplementing anti-VEGF therapy with an
anti-complement such as Zimura® in wet AMD may have the
potential to further enhance the efficacy of anti-VEGF monotherapy and
decrease unwanted side effects in wet AMD from anti-VEGF drugs. A recent
peer reviewed publication from the Journal of Clinical Investigation
from the prestigious Scripps Research Institute citing the role of
anti-VEGF therapy in complement activation supports this thesis. Due to
a new study design and updated enrollment criteria, the Company will
cease enrollment in its current Phase 2a clinical trial of Zimura®
in wet AMD, and initiate a new Phase 2a clinical trial to assess whether
it can replicate findings from its previous Phase 1/2a clinical trial.
The Company will be assessing a range of dosing regimens before
committing to a larger and more costly trial. This trial is scheduled to
initiate before the end of the year.
"The opportunities to develop orphan drugs for ophthalmic diseases along
with some intriguing new developments regarding the role of complement
in anti-VEGF therapy allow us to focus our resources and efforts on
science-driven solutions in addressing the unmet need in ophthalmic
diseases," stated Mr. Sblendorio. "In addition, we have reviewed a large
number of assets and technology platforms over the past few months and
are actively continuing to review, in a prudent manner, assets or
technology platforms which would fit into our strategic goals in
addition to other compelling ophthalmology opportunities."
Conference Call/Web Cast Information
Ophthotech will host a conference call/webcast to discuss the Company's
financial and operating results and provide a business update. The call
is scheduled for July 26, 2017 at 8:00 a.m. Eastern Time. To participate
in this conference call, dial 888-280-4443 (USA) or 719-457-2603
(International), passcode 8248330. A live, listen-only audio webcast of
the conference call can be accessed on the Investor Relations section of
the Ophthotech website at: www.ophthotech.com.
A replay will be available approximately two hours following the live
call for two weeks. The replay number is 888-203-1112 (USA Toll Free),
passcode 8248330. A supplemental slide presentation is available in the
"Investor" section of the Ophthotech website prior to the start of the
call / webcast.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics for diseases of the eye. For more
information, please visit www.ophthotech.com.
Forward-looking Statements
Any statements in this press release about Ophthotech's future
expectations, plans and prospects constitute forward-looking statements
for purposes of the safe harbor provisions under the Private Securities
Litigation Reform Act of 1995. Forward-looking statements include any
statements about Ophthotech's strategy, future operations and future
expectations and plans and prospects for Ophthotech, and any other
statements containing the words "anticipate," "believe," "estimate,"
"expect," "intend", "goal," "may", "might," "plan," "predict,"
"project," "target," "potential," "will," "would," "could," "should,"
"continue," and similar expressions. In this press release, Ophthotech's
forward looking statements include statements about the implementation
of its strategic plan, Ophthotech's projected use of cash and cash
balances, the timing, progress and results of clinical trials and other
development activities, the potential utility or commercialization of
any of Ophthotech's product candidates and its business development
strategy, including any potential in-license or acquisition
opportunities. Such forward-looking statements involve substantial risks
and uncertainties that could cause Ophthotech's clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, those
related to the initiation and conduct of clinical trials, availability
of data from clinical trials, expectations for regulatory matters and
negotiation and consummation of in-license and/or acquisition
transactions, need for additional financing and other factors discussed
in the "Risk Factors" section contained in the quarterly and annual
reports that Ophthotech files with the Securities and Exchange
Commission. Any forward-looking statements represent Ophthotech's views
only as of the date of this press release. Ophthotech anticipates that
subsequent events and developments will cause its views to change. While
Ophthotech may elect to update these forward-looking statements at some
point in the future, Ophthotech specifically disclaims any obligation to
do so except as required by law.
OPHT-G
View source version on businesswire.com: http://www.businesswire.com/news/home/20170726005369/en/
Investors
Ophthotech Corporation
Kathy Galante,
212-845-8231
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
SmithSolve
LLC on behalf of Ophthotech Corporation
Alex Van Rees,
973-442-1555 ext. 111
alex.vanrees@smithsolve.com
Source: Ophthotech Corporation
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