NEW YORK--(BUSINESS WIRE)--
Ophthotech Corporation (Nasdaq:OPHT) today announced that the Phase 2b
study results of Fovista® (pegpleranib), the Company's
anti-PDGF agent administered in combination with Lucentis®
(ranibizumab) anti-VEGF therapy for the treatment of wet age-related
macular degeneration (AMD), have been published online in Ophthalmology®,
the journal of the American Academy of Ophthalmology.
The article in Ophthalmology from this prospective, randomized,
controlled Phase 2b clinical trial of 449 patients with wet AMD,
indicates that Ophthotech's Fovista® (1.5 mg), administered
in combination with Lucentis®, met the pre-specified primary
efficacy endpoint of mean change in visual acuity. Patients receiving
the combination of Fovista® (1.5 mg) and Lucentis®
(0.5 mg) gained a mean of 10.6 letters of vision on the ETDRS
standardized chart at 24 weeks, compared to 6.5 letters for patients
receiving Lucentis® monotherapy (p=0.019). This represents a
62% additional benefit from baseline. No significant safety issues were
observed for either treatment group in the trial.
The published article, "Dual Antagonism of PDGF and VEGF in Neovascular
Age-related Macular Degeneration," can be accessed under "Articles in
Press" at: http://www.aaojournal.org/inpress.
"We are honored to have the findings of the Phase 2b Fovista®
combination therapy study in wet AMD patients published in Ophthalmology,
the journal of the American Academy of Ophthalmology, a highly-respected
peer-review publication," said Samir Patel, M.D., President and
Vice-Chairman of the Board of Ophthotech. "The strength of results of
this large trial represent the basis for our Fovista® in
combination with anti-VEGF therapy Phase 3 registration program for the
treatment of wet AMD."
"We would like to thank all the participating physicians, patients and
their staff for their splendid effort in this well conducted trial. We
look forward to topline data from the two Phase 3 clinical trials of
Fovista® in combination with Lucentis® in the
fourth quarter of this year," said David R. Guyer, M.D., Chief Executive
Officer and Chairman of the Board of Ophthotech.
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. For more information, please
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. 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 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161031005327/en/
Vice President, Investor Relations and Corporate
LLC on behalf of Ophthotech Corporation
973-442-1555 ext. 102
Source: Ophthotech Corporation
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