Ophthotech Announces First Patient Dosed in Zimura® Phase 2/3 Study to Evaluate Treatment in Patients with Geographic Atrophy, an Advanced Form of Dry Age-Related Macular Degeneration
NEW YORK–(BUSINESS WIRE)–Ophthotech Corporation (Nasdaq:OPHT) announced that the first patient
has been dosed in a Phase 2/3 clinical study of Zimura® (avacincaptad
pegol sodium), an inhibitor of complement factor C5, in patients with
geographic atrophy, an advanced form of dry age-related macular
degeneration (AMD). Complement factor C5 is a central component of the
complement cascade believed to be involved in the development of AMD.
The Phase 2/3 randomized, double-masked, controlled trial is designed to
evaluate the safety and efficacy of Zimura® monotherapy in
patients with geographic atrophy. The Company has also recently
announced the initiation of a Phase 2 study of Zimura® in
combination with anti-VEGF therapy in wet AMD patients to potentially
reduce the treatment burden.
“Dry age-related macular degeneration continues to be a significant
unmet medical need globally with no approved treatment options available
to patients,” said David R. Guyer, M.D., Chief Executive Officer and
Chairman of the Board of Ophthotech. “Multiple published studies suggest
that the complement pathway has a central role in dry AMD. We plan to
explore the potential of Zimura® as a treatment for
geographic atrophy. In addition, the emerging strength of science from
published independent genetic variation studies relating to the role of
complement inhibition in wet AMD along with our earlier Zimura®
study results in wet AMD are encouraging. We are therefore pleased to
have recently announced the initiation of a wet AMD treatment burden
reduction study of Zimura® combination therapy. These are
important milestones for Ophthotech as our effort to develop therapies
to treat underserved populations in all forms of AMD continues to
advance.”
About Ophthotech Corporation
Ophthotech is a biopharmaceutical company specializing in the
development of novel therapeutics to treat back of the eye diseases,
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 therapy that represents 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 geographic atrophy, a form of dry AMD, and in combination
with anti-VEGF therapy in wet AMD patients to potentially reduce the
treatment burden. 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 timing and
progress of the Fovista® Phase 3 clinical program, and
the potential of Zimura® as a therapy for geographic
atrophy and, when administered in combination with anti-VEGF drugs, for
wet AMD. 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 factors discussed in the “Risk Factors”
section contained in the quarterly and annual reports that Ophthotech
files with the SEC. 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
Contacts
Investors
Kathy Galante
Ophthotech Corporation
Vice
President, Investor Relations and Corporate Communications
212-845-8231
kathy.galante@ophthotech.com
or
Media
Jennifer
Devine
SmithSolve LLC on behalf of Ophthotech Corporation
973-442-1555
ext. 102
jennifer.devine@smithsolve.com
