- Pivotal data evaluating the safety and efficacy of the
subretinal delivery of ABBV-RGX-314 in patients with wet
age-related macular degeneration (wet AMD) are expected in
2026
- AbbVie and REGENXBIO will plan the Phase 3 clinical program
of investigational ABBV-RGX-314 in diabetic retinopathy
(DR)
NORTH
CHICAGO, Ill. and ROCKVILLE,
Md., Jan. 13, 2025 /PRNewswire/ -- AbbVie
(NYSE: ABBV) and REGENXBIO Inc. (Nasdaq: RGNX) today announced
updates to the ABBV-RGX-314 clinical program.
ABBV-RGX-314 in Wet Age-Related Macular Degeneration (wet
AMD), Subretinal Delivery
Data from the
ATMOSPHERE® and ASCENT™ pivotal trials
evaluating the safety and efficacy of the subretinal delivery of
ABBV-RGX-314 in patients with wet AMD are expected in 2026.
ABBV-RGX-314 in Diabetic Retinopathy (DR),
Suprachoroidal Delivery
AbbVie and REGENXBIO will plan a
Phase 3 clinical program. The clinical program will utilize the
in-office SCS Microinjector® to deliver gene therapy to
the suprachoroidal space of the eye.
"Retinal diseases are progressive, with wet AMD and DR among the
leading causes of blindness," said Michael Robinson, M.D.,
vice president, global head of ophthalmology clinical development,
AbbVie. "More treatment options are needed to help relieve the
current treatment burden of chronic, frequent dosing. We are
excited to continue moving closer to our goal of delivering an
additional treatment option to patients with wet AMD and DR in
hopes of addressing their significant unmet needs."
"ABBV-RGX-314 has the potential to help millions of people
living with wet AMD and DR, globally, who are facing these
debilitating diseases," said Curran
Simpson, president and chief executive officer, REGENXBIO.
"Together with AbbVie, we are excited to continue developing
ABBV-RGX-314 as the first potential one-time gene therapy for wet
AMD and DR."
About ABBV-RGX-314
ABBV-RGX-314 is being investigated as a potential one-time
treatment for wet AMD, diabetic retinopathy and potentially other
chronic retinal conditions. ABBV-RGX-314 consists of the
NAV® AAV8 vector, which encodes an antibody fragment
designed to inhibit vascular endothelial growth factor (VEGF).
ABBV-RGX-314 is believed to inhibit the VEGF pathway by which new,
leaky blood vessels grow and contribute to the accumulation of
fluid in the retina.1
AbbVie and REGENXBIO are advancing the development of two
separate routes of administration of ABBV-RGX-314 to the eye,
through a standardized subretinal delivery procedure as well as
delivery to the suprachoroidal space. REGENXBIO has licensed
certain exclusive rights to the SCS Microinjector® from
Clearside Biomedical, Inc. to deliver gene therapy treatments to
the suprachoroidal space of the eye.
About Wet AMD
Wet AMD is characterized by loss of vision due to new, leaky
blood vessel formation in the retina.2 Wet AMD is a
significant cause of vision loss in the United
States, Europe and Japan, with up to two million
people living with wet AMD in these geographies alone.3
Current anti-VEGF therapies have significantly changed the
landscape for treatment of wet AMD, becoming the standard of care
due to their ability to prevent progression of vision loss in the
majority of patients.4 These therapies, however, require
life-long repeated intraocular injections, to maintain
efficacy.5,6 Due to the burden of treatment, patients
often experience a decline in vision with reduced frequency of
treatment over time.7
About Diabetic Retinopathy
Diabetic retinopathy (DR) is the leading cause of vision loss in
adults between 24 and 75 years of age worldwide.8 DR
affects nearly 10 million people in the
United States alone.9 The spectrum of DR severity
ranges from non-proliferative diabetic retinopathy (NPDR) to
proliferative diabetic retinopathy (PDR).4 As DR
progresses, a large proportion of patients develop vision
threatening complications, including diabetic macular edema (DME)
and neovascularization that can lead to blindness.10
Current treatment options for patients with NPDR typically include
"watchful waiting" or anti-VEGF treatment. For patients with PDR,
current treatment options include anti-VEGF treatment or retinal
laser; surgical treatment may be required for advanced
PDR.2
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
and solutions that solve serious health issues today and address
the medical challenges of tomorrow. AbbVie strives to have a
remarkable impact on people's lives across several key therapeutic
areas – immunology, oncology, neuroscience, and eye care – and
products and services in AbbVie's Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X
(formerly Twitter), and YouTube.
ABOUT REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy. Since its founding in 2009, REGENXBIO has pioneered the
development of AAV Therapeutics, an innovative class of gene
therapy medicines. REGENXBIO is advancing a pipeline of AAV
Therapeutics for rare and retinal diseases, including RGX-202 for
the treatment of Duchenne, ABBV-RGX-314 for the treatment of wet
AMD and diabetic retinopathy, being developed in collaboration with
AbbVie, and RGX 121 for the treatment of MPS II. Thousands of
patients have been treated with REGENXBIO's AAV Therapeutic
platform, including Novartis' ZOLGENSMA® for
children with spinal muscular atrophy. Designed to be one-time
treatments, AAV Therapeutics have the potential to change the way
healthcare is delivered for millions of people. For more
information, please visit www.regenxbio.com.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions and uses
of future or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2023 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
1 Penn JS, Madan A, Caldwell RB, et al. Vascular
endothelial growth factor in eye disease. Prog Retin Eye Res.
2008;27(4):331-71.
2 Carmeliet P. Angiogenesis in life, disease and
medicine. Nature. 2005;438:932-6.
3 Decision Resources Group, 2019
4 Alexandru MR, Alexandra
NM. Wet age related macular degeneration management and
follow-up. Rom J Ophthalmol. 2016;60:9–13.
5 AAO PPP. Preferred Practice Patterns: Age related
macular degeneration. American Academy of Ophthalmology. 2019.
6 Dugel PU, Koh A, Ogura Y, et al. HAWK and
HARRIER: phase 3, multicenter, randomized, double-masked trials of
brolucizumab for neovascular age-related macular degeneration.
Ophthalmology. 2020;127(1):72-84.
7 Holz FG et al. Br J Ophthalmol. 2015;99:220.
8 Cheung N, Mitchell P, Wong TY. Diabetic
retinopathy. Lancet. 2010;376(9735):124–36.
9 Lundeen EA, Burke-Conte Z, Rein DB, Wittenborn
JS, Saaddine J, Lee AY, Flaxman AD. Prevalence of Diabetic
Retinopathy in the US in 2021. JAMA Ophthalmology.
2023;141(8):747-754.
10 Berrocal MD, Alexandra Acabá. Current Management
of Diabetic Retinopathy, 2018
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SOURCE AbbVie