Ophthotech Announces Results from Third Phase 3 Trial of Fovista® in Wet Age-Related Macular Degeneration
August 14 2017 - 6:30AM
Business Wire
Ophthotech Corporation (Nasdaq:OPHT) today
announced that the pre-specified primary endpoint of mean
change in visual acuity at 12 months was not achieved in its Phase
3 clinical trial investigating the superiority of Fovista®
(pegpleranib) anti-PDGF therapy in combination with Eylea®
(aflibercept) or Avastin® (bevacizumab) anti-VEGF therapy compared
to Eylea® or Avastin® monotherapy for the treatment of wet
age-related macular degeneration (AMD). The addition of 1.5mg
of Fovista® to an Eylea® or Avastin® regimen did not
result in benefit as measured by the mean change in visual acuity
at the 12-month time point.
“We express our sincere appreciation to the patients and
clinical investigators and their staffs for their dedication to
completing this third Phase 3 clinical trial of Fovista® in
combination with anti-VEGF therapy,” said Glenn P. Sblendorio,
Chief Executive Officer and President of Ophthotech. “This outcome
does not affect our strategy as the Company moves forward with
multiple ongoing or planned clinical programs in orphan retinal
diseases coupled with multiple ongoing or planned clinical trials
in back of the eye indications.”
This clinical trial (also known as OPH1004) was an
international, multicenter, randomized, double-masked, controlled
Phase 3 study. In the OPH1004 trial, subjects receiving Fovista® in
combination with Eylea® or Avastin® therapy gained a mean of 9.42
letters of vision on the ETDRS standardized chart at 12 months,
compared to a mean gain of 9.04 ETDRS letters in patients receiving
Eylea® or Avastin® monotherapy, a resulting difference of 0.38
ETDRS letters (p=0.74). The results for the pre-specified primary
efficacy analysis were not statistically significant. In addition,
the Company did not observe any clinically meaningful visual
benefit in the pre-specified secondary endpoints when Fovista® was
added to Eylea® or Avastin® regimen. Based on these data, the
Company has decided to stop treating patients who are in the second
year of the OPH1004 study. The Phase 3 trial enrolled approximately
640 patients with wet AMD.
Based on a preliminary analysis of the safety data from the
trial, Fovista® combination therapy and Eylea® or Avastin®
monotherapy were generally well tolerated after one year of
treatment. The ocular adverse events more frequently reported in
the Fovista® combination therapy group compared to the Eylea® or
Avastin® monotherapy group were mainly related to the injection
procedure. The safety profile of Fovista® combination therapy
remains unchanged from prior trials.
In December 2016, Ophthotech announced that the
pre-specified primary endpoint of mean change in visual acuity at
12 months was not achieved in its two pivotal Phase 3 clinical
trials (also known as OPH1002 and OPH1003) investigating the
superiority of Fovista® therapy in combination with Lucentis®
(ranibizumab) anti-VEGF therapy compared to Lucentis® monotherapy
for the treatment of wet AMD. The addition of Fovista® to
a monthly Lucentis® regimen did not result in
benefit as measured by the mean change in visual acuity at the
12-month time point.
About Ophthotech CorporationOphthotech 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 StatementsAny 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, and the potential utility or commercialization of any
of Ophthotech’s product candidates. 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 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
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version on businesswire.com: http://www.businesswire.com/news/home/20170814005286/en/
InvestorsOphthotech CorporationKathy Galante,
212-845-8231Vice President, Investor Relations and Corporate
Communicationskathy.galante@ophthotech.comorMediaSmithSolve
LLC on behalf of Ophthotech CorporationAlex Van Rees,
973-442-1555 ext. 111alex.vanrees@smithsolve.com
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