- First Patient Dosed in an Open-Label Study in Ophthotech's
Anti-Fibrosis Program -
- Fovista® Combination Therapy Phase 2b
Subgroup Analysis for Reduction of Sub-retinal Fibrosis to be Presented
at the 2014 Annual Meeting of the American Academy of Ophthalmology -
NEW YORK--(BUSINESS WIRE)--
Ophthotech Corporation announced today the initiation of the first of
several planned expansion trials, in addition to the ongoing Fovista®
combination therapy Phase 3 clinical program. These expansion trials
will investigate the potential role of Fovista® combination
therapy in reducing sub-retinal fibrosis, addressing sub-optimal
treatment response and reducing treatment burden in wet age-related
macular degeneration (AMD) patients receiving anti-vascular endothelial
growth factor (anti-VEGF) monotherapy. The first expansion trial is a
Phase 2a open-label study investigating the potential role of
anti-platelet derived growth factor (anti-PDGF) therapy in combination
with anti-VEGF therapy in reducing sub-retinal fibrosis in wet AMD
patients.
"The initiation of the Fovista® expansion studies continues
our commitment to advance scientifically-driven therapeutic options to
address an unmet medical need in age-related macular degeneration,"
stated David R. Guyer, M.D., Chief Executive Officer and Chairman of the
Board of Ophthotech. "Today, we are pleased to announce the launch of
the first study in our expansion trial program investigating the
potential effect of administration of Fovista® in combination
with an anti-VEGF agent on sub-retinal fibrosis in wet AMD patients.
Sub-retinal fibrosis is associated with poor visual outcome in patients
receiving anti-VEGF monotherapy for wet AMD. The inhibition of fibrosis
is an urgent and unmet medical need in wet AMD."
"Multiple independently published studies have shown that, over time,
sub-retinal fibrosis is commonly associated with vision loss in wet AMD
patients receiving anti-VEGF monotherapy," stated Samir Patel, M.D.,
President of Ophthotech. "Peer-reviewed studies also indicate that PDGF
is a significant mediator of retinal and organ fibrosis. Coupled with
the findings from the retrospective evaluation from our randomized
controlled Phase 2b trial, we believe these third party studies provide
a strong rationale to investigate whether Fovista® (1.5mg)
combination therapy can reduce sub-retinal fibrosis in patients with
poor visual outcome, compared to anti-VEGF monotherapy. We are designing
the anti-fibrosis expansion trials to provide further information to
support the potential use of Fovista® combination therapy
for reduction of long term visual loss in wet AMD patients."
The Company also announced that a subgroup analysis showing a reduction
of sub-retinal fibrosis and neovascular growth in patients receiving
Fovista® (1.5mg) and Lucentis® in the Company's
Phase 2b trial has been accepted as an oral presentation at this year's
Annual Meeting of the American Academy of Ophthalmology, one of the
major medical meetings for retinal physicians. A featured oral
presentation entitled, "Dual Antagonism of Platelet Derived Growth
Factor (Fovista® 1.5 mg) and Vascular
Endothelial Growth Factor (Lucentis® 0.5 mg)
Results in Reduced Sub-retinal Fibrosis and Neovascular Growth" is
scheduled to be presented on October 21, 2014, at the 2014 American
Academy of Ophthalmology meeting being held in Chicago, IL.
Fovista®
Phase 3 Program
The Fovista® Phase 3 program consists of three
clinical trials to evaluate the safety and efficacy of Fovista®
(anti-PDGF) therapy, which Ophthotech is developing for use in
combination with anti-VEGF drugs for the treatment of wet age-related
macular degeneration. The Company expects to enroll up to 1,866 patients
in the three trials in more than 225 centers worldwide and to have
initial, topline data from the Fovista® Phase 3
clinical program available in 2016.
About Wet AMD
Age-related macular degeneration is a disease characterized by
progressive degenerative abnormalities in the macula of the eye, a small
area in the central portion of the retina. Age-related macular
degeneration is classified into one of two general subgroups: the "dry"
(non-neovascular) form of the disease; and the "wet" (exudative or
neovascular) form of the disease. The "dry" form of AMD is characterized
by a slow degeneration of the macula resulting in atrophy of the central
retina, with gradual vision loss over a period of years. By contrast,
"wet" AMD typically causes sudden, often substantial, loss of central
vision and is responsible for most cases of severe loss of visual acuity
in this disease. Age-related macular degeneration is characteristically
a disease of individuals aged 50 years or older, and is the leading
cause of blindness in developed countries around the world.
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics to treat diseases of the eye, with a
focus on developing innovative therapies for age-related macular
degeneration (AMD). Ophthotech's most advanced product candidate,
Fovista® anti-PDGF therapy, is in Phase 3 clinical trials for use in
combination with anti-VEGF drugs that represent the current standard of
care for the treatment of wet AMD. Ophthotech's second product candidate
Zimura™, an inhibitor of complement factor C5, is being developed for
the treatment of dry and wet forms of AMD. 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 conduct of the
Fovista Phase 3 clinical program, including obtaining initial, top-line
data from the Fovista Phase 3 clinical program, the potential of Fovista
as a wet AMD combination therapy, the conduct of the first Fovista
expansion trial, the initiation of additional clinical trials for
Fovista and obtaining data from these trials. 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 and expectations for
regulatory approvals or other actions and other important factors
discussed in the "Risk Factors" section contained in the quarterly and
annual reports that Ophthotech files with the SEC, including
Ophthotech's quarterly report on Form 10-Q for the quarter ended March
31, 2014. 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.
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
Jarrod Aldom, 973-442-1555
ext. 112
jarrod.aldom@smithsolve.com
Source: Ophthotech Corporation
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