Alimera Sciences Announces Real-World Audit Data Supporting the Positive Benefits of ILUVIEN® Treatment
July 25 2017 - 3:05PM
Alimera Sciences, Inc. (NASDAQ:ALIM) (Alimera), a leader in the
commercialization and development of prescription ophthalmic
pharmaceuticals, today announced that data from an ongoing audit of
real-world U.K. clinical practice, published online July 18, 2017
in Eye, show a significant number of patients with chronic diabetic
macular edema (DME) met the vision level requirement to drive after
receiving a single ILUVIEN® implant. In the U.K., the Driver and
Vehicle Licensing Agency requires a minimum of 6/12 (equivalent to
20/40) visual acuity to drive. The study data showed that at 24
months, the percentage of patients with 20/40 visual acuity
increased from a baseline of 18.1% to 39.6% after receiving the
ILUVIEN implant.
The data were collected on 345 eyes (305 patients) from the
Medisoft™ electronic medical record data systems used in 14 U.K.
centers. At the 24-month point, the data show 86.7% of patients
maintained or gained visual acuity after receiving ILUVIEN in
routine clinical practice. The mean visual acuity increased from
51.9 letters at baseline to 57.2 letters at 24 months, an average
gain of 5.3 letters. Fifteen percent of the patients achieved a ≥15
letter improvement at 12 months, increasing to 20.8% of patients at
24 months.
These visual acuity outcomes were comparable to the ILUVIEN
Phase III clinical trial (FAME) results at 24 months despite
patients from this audit having had more prior intravitreal
treatments and hence more chronic DME. In the FAME trials, all
patients had received prior laser therapy, but few had received
anti-vascular endothelial growth factor (anti-VEGF) therapies.
However, in the Medisoft audit, 84.6% of treated eyes had received
at least one prior intravitreal treatment with a mean of 7.36 prior
intravitreal treatments administered.
Safety issues in the audit were also consistent with the FAME
results. Emergent intraocular pressure (IOP) related events
(defined as use of IOP-lowering medication, a change in IOP ≥10
mmHg from baseline and a rise in IOP >30mmHg, or IOP-lowering
surgery) were consistent with those seen in FAME at a similar
time-point, and within the known safety profile for intravitreal
corticosteroids.
“Often real-world vision outcomes of clinical treatment with
intravitreal anti-VEGF injections are lower than reported in
clinical trials, as fewer injections are often given in real-world
practice. Because one injection of ILUVIEN delivers a continuous
microdose to the retina for up to three years, compliance and
clinical capacity issues are reduced, and we have found that
routine clinical practice achieves similar outcomes to the Phase
III trials,” said Clare Bailey, Consultant Ophthalmologist from
Bristol Eye Hospital, who is leading the Medisoft audit.
About the Medisoft Audit
The ongoing audit collects real-world data on routine clinical
treatment of diabetic macular edema (DME) patients in the U.K. with
0.2µg / day dose of the corticosteroid fluocinolone acetonide
(FAc). The data were collected at 14 U.K. clinical sites using the
Medisoft electronic medical record data system, which is used by
more than 80 National Health System trusts. To meet the requirement
to be included in the audit, these patients must have had chronic
DME considered insufficiently responsive to available therapies.
Retrospective safety data, best-recorded visual acuity and a
limited amount of data from optical coherence tomography have been
gathered on 345 eyes (305 DME patients).
About ILUVIEN
www.ILUVIEN.com.
In the European Union, ILUVIEN is indicated to treat vision
impairment associated with chronic DME considered insufficiently
responsive to available therapies.
About Diabetic Macular Edema (DME)
DME, the primary cause of vision loss associated with diabetic
retinopathy, is a disease affecting the macula, the part of the
retina responsible for central vision. When the blood vessel
leakage associated with diabetic retinopathy results in swelling of
the macula, the condition is called DME. The onset of DME is
painless and may go unreported by the patient until it manifests
with the blurring of central vision or acute vision loss. The
severity of this blurring may range from mild to profound loss of
vision. The Wisconsin Epidemiologic Study of Diabetic Retinopathy
found that over a 10-year period approximately 19% of people with
diabetes included in the study were diagnosed with DME. All people
with type 1 or type 2 diabetes are at risk of developing DME.
About Alimera Sciences, Inc.
www.alimerasciences.com
Alimera, founded in June 2003, is a pharmaceutical company
that specializes in the commercialization, research, and
development of prescription ophthalmic pharmaceuticals. Alimera is
presently focused on diseases affecting the back of the eye, or
retina, because these diseases are not well treated with current
therapies and will affect millions of people in our aging
populations. Alimera’s commitment to retina specialists and their
patients is manifest in Alimera’s product and development portfolio
designed to treat early- and late-stage diseases. Alimera or its
subsidiaries now operate directly in the U.S., U.K., Ireland,
Germany, Austria and Portugal and through third party distribution
agreements in Spain, Italy and the Middle East.
For more information, please
visit www.alimerasciences.com.
For press inquiries:
Katie Brazel
for Alimera Sciences
404-317-8361
kbrazel@bellsouth.net
For investor inquiries:
CG Capital
for Alimera Sciences
877-889-1972
investorrelations@cg.capital
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