Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global
pharmaceutical company whose mission is to be invaluable to
patients, physicians and partners concerned with retinal health and
maintaining better vision longer, announces that the first patient
has been randomized in the DRCR Retina Network’s Protocol AL. The
study is titled, “A Randomized Clinical Trial Evaluating
Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone
Acetonide (0.19 mg) Intravitreal Implants vs Observation for
Prevention of Visual Acuity Loss due to Radiation Retinopathy.”
The study, chaired by Arun Singh, M.D. (Cole Eye Institute,
Cleveland Clinic, Cleveland, Ohio), plans to include 600
participants with primary choroidal melanoma receiving treatment
with plaque brachytherapy. It will assess development of macular
edema and associated long-term visual acuity effects of consistent
and continuous release of corticosteroid or repeated injections of
anti-VEGF initiated near the time of radiation therapy compared to
observation until macular edema develops in patients at risk for
radiation retinopathy.
“We are very excited that this study is underway as it has the
potential to show ILUVIEN addressing another unmet need affecting
the retina,” said Rick Eiswirth, President and Chief Executive
Officer of Alimera. “We believe ILUVIEN with CONTINUOUS
MICRODOSING™ delivery may prevent, delay or reduce the
occurrence of the complication of radiation retinopathy and
consequent vision loss when used in patients treated with plaque
brachytherapy and look forward to the continuing progress of this
study.”
About Radiation Retinopathy
Radiation retinopathy (RR) is a common complication after
Iodine-125 plaque brachytherapy for choroidal melanoma. Although
the initial radiation insult is immediate, clinical onset of RR is
not seen until many months later and RR frequently progresses over
time to profound vision loss. The Collaborative Ocular Melanoma
Study reported that at three years, 45% of patients have visual
acuity 20/200 or worse. A treatment that prevents the development
of RR, or dampens its severity, would have important consequences
for many of these eyes that may be successfully treated for
choroidal melanoma but will likely develop severe RR and loss of
vision over time.
About the DRCR Retina Network (DRCR.net)
The DRCR Retina Network was formed in 2002 and includes clinical
sites and physicians throughout the United States and Canada. It is
funded by the National Eye Institute (NEI), part of the National
Institutes of Health, which is the federal government agency that
funds medical research. The DRCR Retina Network is supported in
overall operation and leadership by the office of the Network
Chairs (Daniel F. Martin, M.D., Cole Eye Institute, Cleveland
Clinic, Cleveland, Ohio and Jennifer K. Sun, M.D., M.P.H., Joslin
Diabetes Center, Harvard Medical School, Boston, Massachusetts) and
the Coordinating Center (Executive Director Adam R. Glassman, M.S.,
Jaeb Center for Health Research, Tampa, FL), and the National Eye
Institute (Project Officer, Sangeeta Bhargava, Ph.D.).
About ILUVIEN
www.ILUVIEN.com
The Company’s primary product is ILUVIEN (fluocinolone acetonide
intravitreal implant) 0.19 mg sustained release intravitreal
implant, injected into the back of the eye. With its CONTINUOUS
MICRODOSING™ technology, ILUVIEN is designed to release
sub-microgram levels of fluocinolone acetonide, a corticosteroid,
for 36 months, to reduce the recurrence of disease, enabling
patients to maintain vision longer with fewer injections. ILUVIEN
is approved in the U.S., Kuwait, Lebanon and the U.A.E. to treat
diabetic macular edema (DME) in patients who have been previously
treated with a course of corticosteroids and did not have a
clinically significant rise in intraocular pressure. In 17 European
countries, ILUVIEN is indicated for the treatment of vision
impairment associated with chronic DME considered insufficiently
responsive to available therapies. In March 2019, ILUVIEN received
approval in the 17 countries under the Mutual Recognition Procedure
for prevention of relapse in recurrent non-infectious uveitis
affecting the posterior segment of the eye. The 17 European
countries include the U.K., Germany, France, Italy, Spain,
Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland,
Sweden, Poland, Czechia, the Netherlands, and Luxembourg. The
non-infectious posterior uveitis indication for ILUVIEN was
launched in Germany and the U.K. in late 2019, Belgium in 2021 and
Spain and Italy in 2022. Alimera markets YUTIQ® (fluocinolone
acetonide intravitreal implant) 0.18mg for treatment of uveitis in
the United States.
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose
mission is to be invaluable to patients, physicians and partners
concerned with retinal health and maintaining better vision longer.
For more information, please visit www.alimerasciences.com.
Forward Looking Statements
This press release contains “forward-looking statements,” within
the meaning of the Private Securities Litigation Reform Act of
1995, regarding, among other things, Alimera’s expectations with
respect to ILUVIEN’s potential to address another unmet need
affecting the retina. Such forward-looking statements are based on
current expectations and involve inherent risks and uncertainties,
including factors that could delay, divert or change any of them,
and could cause actual results to differ materially from those
projected in its forward-looking statements. Meaningful factors
which could cause actual results to differ include, but are not
limited to, ILUVIEN’s ability to prevent or reduce the occurrence
of the complication of radiation retinopathy and consequent vision
loss when used in patients treated with plaque brachytherapy, as
well as other factors discussed in the “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” sections of Alimera’s Annual Report on Form
10-K for the year ended December 31, 2023 which is on file
with the Securities and Exchange Commission (SEC) and
available on the SEC’s website at www.sec.gov.
All forward-looking statements contained in this press release
are expressly qualified by the cautionary statements contained or
referred to herein. Alimera cautions investors not to rely too
heavily on the forward-looking statements Alimera makes or that are
made on its behalf. These forward-looking statements speak only as
of the date of this press release (unless another date is
indicated). Alimera undertakes no obligation, and specifically
declines any obligation, to publicly update or revise any such
forward-looking statements, whether as a result of new information,
future events or otherwise.
For press inquiries:Cassy Dumpfor Alimera
Sciences619-971-1887cassydoespr@gmail.com |
For investor inquiries:Scott Gordonfor Alimera
Sciencesscottg@coreir.com |
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