Under the Symbol:
Alimera Sciences Announces Approval Received in the Mutual Recognition Procedure for New Indication for ILUVIEN(R) in Europe
Monday, March 25, 2019 9:28 AM
- Indication for treatment of non-infectious posterior uveitis further supports the uniqueness of ILUVIEN to consistently and continuously deliver treatment to reduce the recurrence of inflammation
- Regulatory process to now enter the national phase in which each member state finalizes the label to meet local requirements
ATLANTA, GA / ACCESSWIRE / March 25, 2019 / Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, today announced a positive outcome for a new indication for ILUVIEN in Europe. Alimera received the Final Variation Assessment Report (FVAR) for ILUVIEN from the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA) based on Alimera's submission to the MHRA through the Mutual Recognition Procedure. Under that procedure, the United Kingdom has acted as the Reference Member State and prepared an assessment report to share with the 16 other countries in the EEA in which Alimera applied for an additional indication. The FVAR states that ILUVIEN is approved for the additional indication for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). NIPU, which is difficult to treat and primarily affects working age people, can lead to severe vision loss and even blindness.
"The priority when treating patients with NIPU is preventing recurrence of the condition and preserving vision. ILUVIEN has shown to successfully decrease uveitis recurrence rates and reduce vision loss, which will positively impact our patients," said Mr. Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist at Moorfields Eye Hospital, London, U.K. "This is most welcome news and provides an effective additional option for a condition that can be difficult to treat."
ILUVIEN is a sustained release intravitreal implant that controls the recurrence of diabetic macular edema and prevents the relapse of the recurrence of NIPU every day through its CONTINUOUS MICRODOSING™ technology, enabling patients to maintain vision longer with fewer injections.
"Adding this indication in our key European markets is a critical component of our growth strategy," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "We are also very pleased with this indication as it further reinforces our belief in ILUVIEN's ability to continuously and consistently deliver treatment for up to 3 years, reducing the recurrence of inflammation."
The regulatory process will now enter the national phase in which the U.K. and each additional European member state are expected to finalize the label for the new indication to meet each country's local requirements. Timeline to this goal varies by each country.
Upon German approval of the NIPU label, Alimera can launch ILUVIEN for NIPU in Germany without having to pursue reimbursement per the Arzneimittelmarkt-Neuordnungsgesetz (AMNOG) law because fluocinolone acetonide, the active ingredient in ILUVIEN, was available on the German market prior to January 2011.
In the other countries in which ILUVIEN is currently commercialized, Alimera, and its distribution partners where appropriate, will now pursue reimbursement with local health authorities. These countries include the U.K., Ireland, Germany, Austria, Portugal, Italy, Spain and France.
In the U.K., Alimera has been engaged with the National Institute for Health and Clinical Excellence (NICE) to determine the cost effectiveness for ILUVIEN in the treatment of NIPU. The assessment to date has been a non-public process and is ongoing. Alimera anticipates that NICE will provide a public response in the near future and will require the submission of additional data and modeling to the appraisal committee to substantiate ILUVIEN's cost effectiveness, and additional evaluation, before a public committee meeting in May 2019. This assessment process has no effect on any private payer use following the national phase nor on NICE's previous agreement to fund the treatment of pseudophakic eyes in chronic diabetic macular edema patients that are insufficiently responsive to available therapies.
In Europe, ILUVIEN (190µg Fluocinolone Acetonide intravitreal implant in applicator) is now indicated for the prevention of relapse in recurrent non-infectious uveitis of the posterior segment as well as for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies. ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is indicated for the treatment of 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 the United States, Canada, the U.A.E., Lebanon and Kuwait. The sustained release intravitreal implant is injected into the back of the eye and controls the recurrence of symptoms every day through its CONTINUOUS MICRODOSING™ technology, enabling patients to maintain vision longer with fewer injections.
About Non-Infectious Uveitis of the Posterior Segment (NIPU)
Uveitis is inflammation in the middle layer of fibrous tissue enclosing the eye. Uveitis in the posterior segment of the eye can lead to severe, irreversible vision loss and blindness. NIPU is often, but not always, linked to an autoimmune response or associated with a condition that causes an overreactive immune response.
The symptoms associated with NIPU are often recurrent. Signs include a loss of visual acuity, increased visual haze and increased thickness of the retina. If left untreated, NIPU can cause other ocular conditions and complications, including glaucoma, cataract formation or macular edema.
About Alimera Sciences, Inc.
Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization 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. 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 belief that the indication for NIPU in its key European markets will prove to be a critical component of its growth strategy and Alimera's expectation that each additional European state will finalize the label for the new NIPU indication to meet local requirements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change either of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors that could cause actual results to differ include, but are not limited to, (a) a failure to achieve the level of sales of ILUVIEN that Alimera expects from the new NIPU indication in Europe due to a lack of end user demand, unanticipated competition, regulatory issues, or other unexpected circumstances and (b) 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, 2018, which is on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.
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SOURCE: Alimera Sciences, Inc.