Alimera Announces Regulatory Approval for ILUVIEN® in Benelux Countries for The Treatment of Non-Infectious Posterior Uveitis
Company continues to execute on its international expansion strategy
The complete Benelux approval was achieved when The Netherlands’ Medicines Evaluation Board informed Alimera of their approval on
“We are pleased to now have the approvals for this new indication for ILUVIEN across Benelux so that our partner,
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.
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.,
Alimera, founded in
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.
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Source: Alimera Sciences, Inc.