- Initial, Topline Data From Both Phase 3 Trials of Fovista®
in Combination with Lucentis® Expected to be
Available in 4Q 2016 -
NEW YORK--(BUSINESS WIRE)--
Ophthotech Corporation (Nasdaq:OPHT) today announced the completion of
patient recruitment for its second Phase 3 trial of Fovista®
(pegpleranib) in combination with Lucentis® (ranibizumab) for
the treatment of wet age-related macular degeneration (AMD). The Company
expects to announce initial, topline data from both Phase 3 trials of
Fovista® in combination with Lucentis® in the
fourth quarter of 2016.
"Completion of patient recruitment in these two large scale Phase 3
clinical trials of Fovista® anti-PDGF therapy in combination
with Lucentis® is a significant milestone in the Fovista®
Phase 3 pivotal program," stated David R. Guyer, M.D., Chief Executive
Officer and Chairman of the Board of Ophthotech. "We believe that Fovista®
administered in combination with anti-VEGF therapy may represent a
significant advancement in the treatment of wet AMD, and we look forward
to obtaining data from both of these studies."
"We are excited with the progress of the Phase 3 Fovista®
clinical development program and grateful for the diligence and
commitment of the participating clinical investigators," stated Samir
Patel, M.D., President and Vice-Chairman of the Board of Ophthotech.
"The effects of wet AMD are debilitating and represent a significant
unmet need. Completion of recruitment in this study brings us one step
closer to our goal of potentially introducing a new class of therapy and
improving visual outcome for wet AMD patients."
The two Phase 3 trials investigating the superiority of Fovista®
in combination with Lucentis® compared to Lucentis®
monotherapy are identical with respect to the trial design in the first
year. Therefore the database from both trials will be locked and
analyzed together to optimize pooled analysis of certain relevant
endpoints in accordance with the statistical analysis plan.
A third Phase 3 trial, which is investigating Fovista® in
combination with either Eylea® (aflibercept) or Avastin®
(bevacizumab), continues to enroll patients with recruitment on track.
Ophthotech continues to explore and consider various regulatory filing
options with the goal of providing Fovista® to physicians for
their patients with wet AMD as quickly as possible, assuming favorable
trial results from the Phase 3 program. The Company believes that the
most likely strategy is to initially submit a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) for Fovista®
in combination with Lucentis® based on data from the two
Phase 3 trials of Fovista® in combination with Lucentis®,
and to subsequently submit an amendment to the NDA with data from the
Phase 3 trial of Fovista® in combination with Eylea® or
Avastin®. Alternatively, the Company may elect to file a
supplemental NDA for Fovista® in combination with Eylea®
or Avastin® following FDA review of the NDA for Fovista®
in combination with Lucentis®.
The FDA granted Fast Track status for Fovista® for the
treatment of wet AMD in September 2013. The Company believes Fovista®
is the most advanced anti-PDGF agent in development for the treatment of
wet AMD and, if approved, is expected to be first to market in this
class of novel therapies for wet AMD.
About the 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 therapy for the treatment of wet AMD. The Company expects
to enroll a total of approximately 1,866 patients in the three trials in
more than 225 centers worldwide.
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. 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,
obtaining initial, topline data from these clinical trials, seeking
marketing approval for Fovista® and the related
regulatory strategy, the potential of Fovista® as a
wet AMD combination therapy, and the potential commercial availability
of Fovista®. 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151026006213/en/
Investors
Ophthotech Corporation
Kathy Galante,
212-845-8231
Vice President, Investor Relations and Corporate
Communications
kathy.galante@ophthotech.com
or
Media
Jennifer
Devine, 973-442-1555 ext. 102
SmithSolve LLC on behalf of
Ophthotech Corporation
jennifer.devine@smithsolve.com
Source: Ophthotech Corporation
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