Graybug Vision Completes Treatment Phase of ALTISSIMO Trial in Wet AMD with 12-Month Topline Data Expected in Second Quarter ...
January 07 2021 - 7:30AM
Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage
biopharmaceutical company focused on developing transformative
medicines to treat chronic vision-threatening diseases of the
retina and optic nerve, today announced the last patient visit in
its GB-102 Phase 2b ALTISSIMO core trial (the 12-month treatment
phase) in wet age-related macular degeneration (wet AMD). ALTISSIMO
12-month topline data are expected to be announced in the second
quarter of 2021, with full results to be presented at a medical
conference later in the year.
Of the 56 patients enrolled in ALTISSIMO, 50 patients completed
the 12-month treatment phase, while the remaining six patients
withdrew for reasons unrelated to their treatment. Furthermore, 58
percent of patients who completed their Month 12 visit were
eligible and agreed to continue clinical monitoring in a six-month
extension of the trial. The goal of this six-month extension period
is to observe further durability of GB-102 in wet AMD patients.
“We are pleased with the completion of treatment in ALTISSIMO
which is expected to provide important data regarding the duration
of treatment, safety and tolerability of GB-102 in wet AMD,” said
Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug Vision.
“Wet AMD is a leading cause of vision loss among the elderly with
outcomes adversely affected by the high treatment burden of
approved medications which need to be injected up to 12 times per
year. The findings of this trial, designed to measure the
durability of a twice-per-year dosing, may potentially demonstrate
the need for fewer treatments per year, and we look forward to
sharing the topline results in the second quarter of 2021.”
Graybug’s lead product candidate, GB-102, is a proprietary
microparticle depot formulation of the pan-vascular endothelial
growth factor (pan-VEGF) inhibitor, sunitinib malate, designed to
be administered intravitreally twice per year. GB-102 seeks to
reduce the need for frequent intravitreal injections by expanding
treatment duration to six months, and potentially longer, thus
reducing the burden of current anti-VEGF treatments which require
up to 12 injections per year.
About GB-102 Phase 2b Clinical Trial in Wet AMD
(ALTISSIMO)
ALTISSIMO comprises a 12-month, multicenter, prospective,
masked, randomized trial comparing GB-102 administered every six
months to aflibercept administered every two months in patients
with anti-VEGF-responsive wet AMD, followed by an additional
six-month observational period. The objective of the ALTISSIMO
Phase 2b core trial is to assess the safety, tolerability, and
pharmacodynamic profile of GB-102. The findings will inform the
design of Graybug’s pivotal Phase 3 clinical trial program in wet
AMD expected to initiate in the second half of 2021.
About Wet AMD
Wet AMD is one of the most common retinal diseases, leading to
vision decline caused by excess VEGF. VEGF is a protein produced by
cells that stimulates the formation of abnormal new blood vessels
behind the retina, called choroidal neovascularization. The leakage
of fluid and protein from the vessels causes retinal degeneration
and leads to severe and rapid loss of vision. Early intervention is
essential to treat wet AMD. The prevalence of wet AMD in the United
States is estimated at 1.5 million people and approximately 25
million people are affected by wet AMD worldwide.
About Graybug Vision
Graybug is a clinical-stage biopharmaceutical company focused on
developing transformative medicines for the treatment of diseases
of the retina and optic nerve. The company’s proprietary ocular
delivery technologies are designed to maintain effective drug
levels in ocular tissue for six months and potentially longer,
improving disease management, reducing healthcare burdens and
ultimately delivering better clinical outcomes. Graybug’s lead
product candidate, GB-102, a microparticle depot formulation of the
pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib
malate, targeting a six-month or longer dosing regimen, inhibits
multiple neovascular pathways for the intravitreal treatment of
retinal diseases, including wet age-related macular degeneration.
Graybug is also using its proprietary technologies to develop
GB-401, an injectable depot formulation of a beta-adrenergic
blocker prodrug, for primary open-angle glaucoma, with a dosing
regimen of once every six months or longer, and GB-103, a
longer-acting version of GB-102, designed to maintain therapeutic
drug levels in the retinal tissue for 12 months with a single
injection. Founded in 2011 on the basis of technology licensed from
the Johns Hopkins University School of Medicine, Graybug is
headquartered in Redwood City, California. For more information,
please visit www.graybug.vision.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the “safe harbor” provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to statements regarding the company’s clinical pipeline,
its ability to advance GB-102, GB-103, GB-401, or any future
product candidate through clinical development, its ability to
achieve its anticipated milestones, including the completion of the
ALTISSIMO trial, within the timing outlined above or at all, its
ability to conduct planned operations within the evolving
constraints arising from the COVID-19 pandemic, and the timing and
results of its clinical trials. Forward-looking statements are
subject to risks and uncertainties that may cause the company’s
actual activities or results to differ significantly from those
expressed in any forward-looking statement, including risks and
uncertainties described under the heading “Risk Factors” in the
company’s quarterly report on Form 10-Q for the three months ended
September 30, 2020, and the other reports the company files from
time to time with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date of this
press release, and the company undertakes no obligation to revise
or update any forward-looking statements to reflect events or
circumstances after the date hereof.
Investor ContactIR@graybug.vision(650)
487-2409 |
Media Contactmedia@graybug.vision(404)
384-0067 |
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