Alimera Completes Recruitment for the Synchronicity Study
January 04 2024 - 8:00AM
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, today announces that it has
completed enrollment for the company’s Synchronicity Study, a
prospective, open-label clinical study evaluating the safety and
efficacy of YUTIQ (fluocinolone acetonide intravitreal implant
0.18mg) in the treatment of chronic non-infectious uveitis and
related intraocular inflammation.
“We are pleased to reach the enrollment target for this Phase 4
open-label study only a few short months after our acquisition of
YUTIQ,” said Rick Eiswirth, Alimera’s President and Chief Executive
Officer. “We look forward to the initial readout from this study in
the second half of next year to provide retina specialists with a
broader sense of the utility of fluocinolone acetonide in a durable
intravitreal implant across a variety of patients with chronic
non-infectious uveitis affecting the posterior segment (NIU-PS).
This could potentially benefit both YUTIQ in the United States and
ILUVIEN in Europe and the Middle East, where it is approved to
treat chronic NIU-PS.”
About Synchronicity
The Synchronicity Study is a multicenter, open label study
evaluating YUTIQ in chronic inflammation. The Synchronicity Study
currently has enrolled 110 patient eyes in approximately 25 sites
around the U.S.
Patients who meet the entry criteria receive YUTIQ (fluocinolone
acetonide intravitreal implant) 0.18 mg as an intravitreal
injection in the designated study eye. The treatment period is 36
months, with data capture for this study being the first 24 months
of YUTIQ drug treatment.
The primary outcome measure for the SYNCHRONICITY Study is the
mean change from baseline in BCVA letter score in the study eye
measured by EDTRS at Month 6 and the mean change from baseline
central subfield thickness at Month 6. Key secondary endpoints
include time to recurrence of non-infectious inflammation in the
study eye, presence of vascular leakage at Months 1, 3, 6, 12, 18,
and 24, proportion of subjects with resolution of macular edema at
Months 1, 3, 6, 12, 18, and 24, mean change from baseline in BCVA
letter score at Day 14 and at Months 1, 3, 12, 18, and 24, and mean
change from baseline in CST at Months 1, 3, 12, 18, and 24. Full
study details are available at https://clinicaltrials.gov.
About YUTIQ
YUTIQ is a sustained release fluocinolone acetonide intravitreal
implant injected into the back of the eye using CONTINUOUS
MICRODOSING™ technology, which is designed to release sub-microgram
levels of fluocinolone acetonide, a corticosteroid, for up to 36
months, to reduce the recurrence of disease and enable patients to
maintain vision longer with fewer injections. YUTIQ helps provide
CONTINUOUS CALM™ by reducing recurrence of inflammation in the
treatment of chronic non-infectious uveitis affecting the posterior
segment of the eye. For more information, please visit
www.YUTIQ.com
About Non-Infectious Uveitis Affecting the Posterior
Segment (NIU-PS)
It is a diverse group of non-infectious uveitic inflammatory
conditions that can affect the posterior segment of the eye. NIU-PS
can affect people of all ages, producing swelling and destroying
eye tissues, which can lead to severe vision loss and blindness and
is a leading cause of working age blindness in many countries.
Patients with NIU-PS are typically treated with systemic steroids,
which are effective, but over time frequently lead to serious side
effects, ranging from acne, weight gain, sleep and mood disorders
to hypertension and osteoporosis that can limit effective dosing.
Patients then often progress to steroid-sparing therapy with
systemic immune suppressants or biologics, which may also have
severe side effects, including an increased risk of cancer and
infection.
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 the anticipated results of the NEW DAY Study. Such
forward-looking statements are based on current expectations and
involve inherent risks and uncertainties (some of which are beyond
Alimera’s control), including factors that could delay, divert or
change any of them, and could cause actual results to differ
materially from those projected in these forward-looking
statements. Other factors are discussed in the “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” sections of Alimera’s recently filed
Quarterly Report on Form 10-Q, most recently filed Annual Report on
Form 10-K, and any of Alimera’s subsequent filings 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 on the
forward-looking statements Alimera makes or that are made on its
behalf as predictions of future events. These forward-looking
statements speak only as of the date of this press release. 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,
except as may be required under applicable securities
laws.
For press
inquiries:Jules Abrahamfor Alimera
Sciences917-885-7378julesa@coreir.com |
For investor inquiries:Scott Gordonfor Alimera
Sciencesscottg@coreir.com |
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