Following successful launch of ILUVIEN in France, Horus will bring the product to patients in Belgium, the Netherlands, and Luxembourg
ATLANTA, Sept. 12, 2019 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (ALIM) (“Alimera”), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that it has expanded its relationship with Horus Pharma, one of the Company’s current distributors of ILUVIEN® in Europe. Following the successful launch of ILUVIEN for diabetic macular edema (DME) in France by Horus Pharma, Alimera Sciences and Horus have agreed to expand their relationship to introduce ILUVIEN for both DME and non-infectious posterior uveitis (NIPU) in the Benelux countries of Belgium, the Netherlands and Luxembourg.
Horus Pharma estimates that there are approximately 70,000 patients within the Benelux countries who may be affected by DME. With ILUVIEN approved for both DME and NIPU in the Benelux, Horus will undertake the process of applying for reimbursement in each Benelux nation for each indication over the next 12-18 months.
“We have enjoyed a productive and successful relationship with Horus Pharma, as they have obtained reimbursement for ILUVIEN in France and are executing an impressive launch in that territory,” said Rick Eiswirth, president and CEO of Alimera. “For those reasons, we made the decision to expand our relationship to include the Benelux countries where Horus also has considerable experience and reach. We look forward to potentially adding these three more countries to the list of anticipated ILUVIEN launches, as we continue to execute on our global commercial expansion strategy.”
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 percent 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)
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.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant, injected into the back of the eye. With its CONTINUOUS MICRODOSING™ 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, Australia, 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. See www.ILUVIEN.com for important safety information.
About Horus Pharma S.A.S.
Founded in 2003, Horus Pharma is an independent French laboratory specialized in ophthalmology. Horus is a European and independent ophthalmology laboratory and 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 has developed recognized expertise in the development of preservative-free formulations and product delivery systems. For further details, please visit www.horus-pharma.com.
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 we believe these diseases are not well treated with current therapies and will affect millions of people in 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 certain patient populations will both increase and benefit from ILUVIEN, that Horus will obtain reimbursement and successfully launch ILUVIEN in the Benelux countries and that Alimera will continue to execute on its strategy to grow ILUVIEN sales in existing markets and introduce the product in new territories to maximize the value of this differentiated therapy. 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, 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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