Alimera Announces Regulatory Approval for ILUVIEN in Benelux Countries for The Treatment of Non-Infectious Posterior Uveitis

Posted on December 03, 2019 by Medtech[y] Staff


Alimera Sciences, Inc. (Nasdaq: ALIM), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that the governmental agencies that oversee the availability of medical products in Belgium, The Netherlands and Luxembourg, collectively known as the Benelux countries, have each granted marketing authorization for ILUVIEN for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye.

The complete Benelux approval was achieved when The Netherlands’ Medicines Evaluation Board informed Alimera of their approval on November 6, 2019. The approval by Belgium’s Federal Agency for Medicines and Health Products was received in May of 2019, and Luxembourg’s Heads of Medicines Agencies provided its confirmation of regulatory approval in late October. Alimera announced in September that it was expanding its relationship with French distribution partner, Horus Pharmaceuticals, who will help the Company achieve reimbursement in all three countries, after which it will oversee distribution throughout Benelux for the new indication.

“We are pleased to now have the approvals for this new indication for ILUVIEN across Benelux so that our partner, Horus Pharmaceuticals, can now pursue reimbursement in each of these markets for both diabetic macular edema and posterior segment non-infectious uveitis,” said Rick Eiswirth, president and CEO of Alimera. “Following a strong launch in France for diabetic macular edema, we are excited to see what Horus can do with ILUVIEN in these countries, providing us with additional markets in Europe where we believe ILUVIEN can help physicians control the recurrence of disease in patients who have either of these conditions.”

See www.ILUVIEN.com for important safety information.

About Non-Infectious Posterior Uveitis

Posterior segment non-infectious uveitis (NIPU) is a chronic, inflammatory disease affecting the posterior segment of the eye, often involving the retina, and is a leading cause of blindness in developed and developing countries. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. Patients with NIPU 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 also can have severe side effects, including an increased risk of cancer and infection. As a result, there remains a significant need for new therapies with improved efficacy, tolerability, and safety profiles to manage this disease.

About ILUVIEN

ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSINGTM technology, ILUVIEN is designed to release submicrogram levels of fluocinolone acetonide, a corticosteroid, for up to 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections. ILUVIEN is approved in the U.S., Canada, 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, Czech Republic, the Netherlands, and Luxembourg. The regulatory process is now in the national phase in which the European member states have finalized or 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. ILUVIEN is not approved for treatment of uveitis in the United States.

About Alimera Sciences, Inc.

Alimera, founded in June 2003, is a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals for the management of retinal diseases. 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, regarding Alimera’s expectation that the European roll out of ILUVIEN’s newly approved indication for the treatment of NIPU will be a growth driver of Alimera’s business. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change these expectations, and could cause actual results to differ materially from those projected in these forward-looking statements. Meaningful factors that could cause actual results to differ include, but are not limited to, (a) whether physicians and patients will be receptive to using ILUVIEN for NIPU or DME in the Benelux countries as Alimera expects, (b) whether and when reimbursement for the indications are granted and to what amounts, in any or all the Benelux and (c) 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 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, which are on file with the Securities and Exchange Commission and available on its website at http://www.sec.gov.