- Post-hoc analysis from the GATHER trials, for
the first time, signals that reduced rate of vision loss in
patients receiving avacincaptad pegol (ACP) was correlated with
reduced geographic atrophy (GA) growth -
- Post-hoc time-to-event analyses signal fewer
patients receiving ACP had 10-, 15- and 20-letter losses from
baseline at two consecutive visits up to 12 months compared to sham
-
IVERIC bio, Inc. (Nasdaq: ISEE) today announced new findings
from exploratory analyses of data for avacincaptad pegol (ACP),
which were presented today at the 2023 annual meeting of the
Association for Research in Vision and Ophthalmology (ARVO), in New
Orleans.
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the full release here:
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ACP, avacincaptad pegol; BCVA, best
corrected visual acuity; GA, geographic atrophy. Without BCVA
(vision) loss group was defined as patients who had a change in
BCVA from baseline at Month 12 less than the categorical value.
(Graphic: Business Wire)
A post-hoc analysis from the GATHER1 and GATHER2 pivotal Phase 3
clinical trials showed, for the first time in an interventional
study in GA, a relationship between GA growth and worsening vision
loss. In this combined analysis, greater vision loss was correlated
with increased GA growth. See accompanying graph.
“This is the first time a relationship between disease
progression and worsening visual acuity has been observed in GA,
connecting anatomy and function,” said Carl Danzig, M.D., Director,
Vitreo-Retinal Services, Rand Eye Institute, Deerfield Beach,
Florida, who presented the findings at ARVO. “These data suggest
that in the ACP-treated group, the reduction in growth of GA
resulted in an overall lower rate of vision loss.”
As previously announced, the post-hoc analysis of GATHER1 and
GATHER2 combined data signaled a 56% risk reduction in the rate of
persistent vision loss in GA patients receiving ACP 2 mg compared
to sham over the first 12 months of treatment. Persistent vision
loss was defined as a loss of ≥15 letters in Best Corrected Visual
Acuity (BCVA) from baseline measured at any two consecutive visits
up to month 12. Multiple sensitivity analyses were conducted to
evaluate this finding, including 10- and 20-letter loss at two
consecutive visits up to month 12, and results were consistent.
About Avacincaptad Pegol
Avacincaptad pegol (ACP) is an investigational drug for
treatment of geographic atrophy (GA) secondary to age-related
macular degeneration (AMD) that is currently under evaluation for
safety and efficacy by the U.S. FDA. ACP is a novel complement C5
protein inhibitor. Overactivity of the complement system and the C5
protein are suspected to play a critical role in the development
and growth of scarring and vision loss associated with GA secondary
to AMD. By targeting C5, ACP has the potential to decrease activity
of the complement system that causes the degeneration of retinal
cells and potentially slow the progression of GA.
About Geographic Atrophy
Age-related macular degeneration (AMD) is the major cause of
moderate and severe loss of central vision in aging adults,
affecting both eyes in the majority of patients. The macula is a
small area in the central portion of the retina responsible for
central vision. As AMD progresses, the loss of retinal cells and
the underlying blood vessels in the macula results in marked
thinning and/or atrophy of retinal tissue. Geographic atrophy,
associated with AMD, leads to further irreversible loss of vision
in these patients.
About the GATHER Clinical Trials
ACP met its primary endpoint in the completed GATHER1 clinical
trial and the ongoing GATHER2 clinical trial, both of which are
randomized, double-masked, sham-controlled, multicenter Phase 3
clinical trials. These clinical trials evaluated the safety and
efficacy of monthly 2 mg intravitreal administration of ACP in
patients with GA secondary to AMD. For the first 12 months in both
trials, patients were randomized to receive either ACP or sham
monthly. There were 286 participants enrolled in GATHER1 and 448
participants enrolled in GATHER2. The primary efficacy endpoints in
both pivotal trials were based on GA area measured by fundus
autofluorescence at three time points: Baseline, Month 6, and Month
12. The mean rate of growth (slope) in GA area from baseline to
month 12 using observed data was 35% in GATHER1 and 18% in GATHER2.
In GATHER1 and GATHER2 combined, the most frequently reported
treatment emergent adverse events at 12 months in the 2 mg
recommended dose were related to the injection procedure. The most
common adverse reactions (≥ 5% and greater than sham) reported at
12 months in patients who received ACP 2 mg were conjunctival
hemorrhage (13%), increased IOP (9%), and CNV (7%).
About Iveric Bio
Iveric Bio is a science-driven biopharmaceutical company focused
on the discovery and development of novel treatments for retinal
diseases with significant unmet medical needs. The Company is
committed to having a positive impact on patients’ lives by
delivering high-quality, safe, and effective treatments designed to
address debilitating retinal diseases including earlier stages of
age-related macular degeneration. For more information on the
Company, please visit www.ivericbio.com.
Forward-looking Statements
Any statements in this press release about the Company’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 the Company’s strategy,
future operations and future expectations and plans and prospects
for the Company, and any other statements containing the words
“anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,”
“may”, “might,” “plan,” “predict,” “project,” “seek,” “target,”
“potential,” “will,” “would,” “could,” “should,” “continue,”
“signal,” and similar expressions. In this press release, the
Company’s forward-looking statements include statements about its
expectations regarding the results and implications of the clinical
data from its GATHER1 and GATHER2 trials of ACP in geographic
atrophy, including the relevance of post-hoc analyses from these
trials, and the potential safety and efficacy of ACP in treating
GA. Such forward-looking statements involve substantial risks and
uncertainties that could cause the Company’s 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 expectations for regulatory matters,
interpretation of clinical trial results by the scientific and
medical community, developments from the Company’s competitors and
the marketplace for the Company’s products, and other factors
discussed in the “Risk Factors” section contained in the quarterly
and annual reports that the Company files with the Securities and
Exchange Commission. Any forward-looking statements represent the
Company’s views only as of the date of this press release. The
Company anticipates that subsequent events and developments may
cause its views to change. While the Company may elect to update
these forward-looking statements at some point in the future, the
Company specifically disclaims any obligation to do so except as
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230423005028/en/
Investor Contact: Kathy Galante Senior Vice President,
Investor Relations kathy.galante@ivericbio.com
or
Media Contact: Jeannie Neufeld Senior Director, Public
Relations & Communications jeannie.neufeld@ivericbio.com
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