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ILUVIEN receives pricing and reimbursement approvals for both diabetic macular edema and posterior uveitis indications simultaneously
ATLANTA, Aug. 26, 2020 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the development and commercialization of prescription ophthalmic pharmaceuticals, announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary received an add-on status for the pricing and reimbursement approval for ILUVIEN® in the Netherlands from the Ministry of Health, effective September 1, 2020. Pricing and reimbursement approval was sought and secured by Alimera’s distribution partner in France and the Benelux region, Horus Pharma S.A.S. (Horus). Horus is in the process of reviewing launch plans.
“We are extremely pleased to have received this national coverage decision for ILUVIEN’s diabetic macular edema and non-infectious posterior uveitis indications in the Netherlands at the same time,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “Given Horus’s impressive performance on the launch of ILUVIEN in France, we look forward to expanding distribution and sales in the Benelux region, and continuing to execute on our international growth strategy.”
ILUVIEN is a sustained release intravitreal implant indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
“We are genuinely pleased that for the second time, our collaboration with Alimera Sciences regarding ILUVIEN in Europe, has been fruitful,” said Maja Lausevic, Chief Operating Officer, Horus Pharma. “Access to ILUVIEN therapy is widely anticipated by ophthalmologists and patients in the Netherlands, and we are enthusiastic to provide this unique therapeutic solution to them and look forward to the official launch.”
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., 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, Czechia, the Netherlands, and Luxembourg. The non-infectious posterior uveitis indication for ILUVIEN was launched in Germany and the U.K. in 3Q 2019. ILUVIEN is not approved for treatment of uveitis in the United States.
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 Non-Infectious Posterior Uveitis (NIPU)
Posterior segment non-infectious uveitis 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 Alimera Sciences, Inc.
Alimera Sciences 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 affect millions of people in our aging populations. For more information, please visit www.alimerasciences.com.
About Horus Pharma S.A.S.
Founded in 2003 in France, Horus Pharma is an independent European laboratory specialized in ophthalmology. It has been recognized to date as one of the main innovative European actors in corneal reconstruction treatments, particularly in the areas of dry eye, scarring and keratoconus. Focused on patient safety, Horus Pharma has developed recognized expertise in the development of preservative-free formulations and product delivery systems. For further details, please visit www.horus-pharma.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 expectations with respect to access to ILUVIEN for patients in the Netherlands. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in its forward-looking statements. Meaningful factors which could cause actual results to differ include, but are not limited to, Horus’ ability to launch ILUVIEN in the Netherlands for both uveitis and DME, the willingness of healthcare professionals and organizations in the Netherlands to adopt ILUVIEN for the two indications and Horus’s ability to get pricing and reimbursement in the remaining Benelux countries, Belgium and Luxembourg, as well as 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, 2019 and Quarterly Reports on Form 10-Q for the quarters ended March 31, 2020 and June 30, 2020, which are on file 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 too heavily on the forward-looking statements Alimera makes or that are made on its behalf. These forward-looking statements speak only as of the date of this press release (unless another date is indicated). Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
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