The UK National Institute for Health and Care Excellence (NICE) Issues Final Draft Guidance to Provide Patients with a Natural Lens (Phakic Eye) Being Treated for Chronic Diabetic Macular Edema Access to ILUVIEN®
February 08 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, announces that the National
Institute for Health and Care Excellence (NICE) has issued Final
Draft Guidance recommending that patients with a natural lens
(phakic patients) being treated for chronic diabetic macular edema
(DME) have access to ILUVIEN 190 microgram intravitreal implant in
applicator (fluocinolone acetonide).
“This is great news that NICE has issued final
draft guidance to make ILUVIEN available for phakic patients
suffering with chronic DME,” said Rick Eiswirth, President and
Chief Executive Officer of Alimera. “These patients represent up to
75% of the overall DME population in the United Kingdom* who will
now potentially have access to ILUVIEN to help control the
recurrence of the disease for up to 36 months. We look forward to
the publication of Final Guidance shortly.”
NICE is recommending on label access to ILUVIEN as
an option for treating visual impairment caused by chronic DME in
phakic eyes. The Final Guidance for ILUVIEN in phakic eyes will be
issued after February 22, 2024, when it will be combined with the
previous NICE recommendation for patients with a pseudophakic lens
and re-issued as a single updated guidance from NICE.
NHS England has agreed with the Integrated Care
Boards (ICB’s) to provide funding to implement this guidance 30
days after publication. NHS Wales will usually fund within 2 months
of the final draft guidance.
*From the UK Macular Society submission included in
the NICE TA824 review, page 9.
About ILUVIEN
www.ILUVIEN.com
https://iluvien.co.uk/prescribing-information/
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.
ILUVIEN is marketed for the non-infectious posterior uveitis
indication in Germany, France, the U.K., the Netherlands, Portugal,
Spain, Austria, Ireland and Italy. ILUVIEN is not approved for
treatment of uveitis in the United States.
About Alimera Sciences, Inc.
www.alimerasciences.com
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 includes “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 NICE issuing a Final Guidance
document. Words such as “anticipate,” “believe,” “estimate,”
“expect,” “intend,” “may,” “plan,” “contemplates,” “predict,”
“project,” “target,” “likely,” “potential,” “continue,” “ongoing,”
“will,” “would,” “should,” “could,” or the negative of these terms
and similar expressions or words, identify forward-looking
statements. 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.
These risks and uncertainties include, but are not
limited to, the reaction of physicians in the United Kingdom to the
inclusion of phakic patients in the NICE guidance for ILUVIEN,
including those physicians’ willingness and ability to use ILUVIEN
to treat appropriate patients, as well as those factors discussed
in the “Risk Factors” and “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” sections of
Alimera’s most recently filed Annual Report on Form 10-K, most
recently filed Quarterly Report on Form 10-Q, 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 to publicly update or
revise any of the forward-looking statements made in this press
release, 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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