Alimera Sciences Announces National Pricing and Reimbursement Granted for ILUVIEN® for DME in Belgium
On August 24, 2021, Alimera Sciences (NASDAQ: ALIM) announced that its European subsidiary received pricing and reimbursement approval for ILUVIEN® for diabetic macular edema (DME) in Belgium, facilitated by its partner, Horus Pharma S.A.S. This approval marks a strategic expansion of ILUVIEN availability in Europe, aimed at enhancing growth in the Benelux region. ILUVIEN is a sustained-release intravitreal implant designed to treat vision impairment associated with chronic DME and prevent relapse in non-infectious uveitis.
- Approval of ILUVIEN for DME in Belgium may increase sales and market penetration in Europe.
- Strategic partnership with Horus Pharma could enhance distribution and marketing efforts in the Benelux region.
- None.
ATLANTA, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a pharmaceutical company that specializes in the commercialization and development of prescription ophthalmic pharmaceuticals, announces that Alimera Sciences Europe Limited, its Ireland-based European subsidiary, received pricing and reimbursement approval for ILUVIEN® for diabetic macular edema (DME) in Belgium from the National Institute for Health and Disability Insurance (INAMI). 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 currently in the launch phase in Belgium.
“The continued expansion of ILUVIEN availability throughout Europe further represents the execution of our international growth strategy,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We anticipate this will fuel even more growth for ILUVIEN in the Benelux region behind the strength of the Horus team.”
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).
About ILUVIEN
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant that is 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 up to 36 months, to reduce the recurrence of disease and number of treatments required, 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 (NIU-PS). 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
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.
Forward Looking Statements
This press release may contain “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 the growth of ILUVIEN sales in the Benelux region. 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. These factors include the ability of Alimera’s distributor Horus Pharma S.A.S. to effectively market ILUVIEN and the willingness of physicians, patients and payers to adopt ILUVIEN.
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.
| For press inquiries: Jules Abraham for Alimera Sciences 917-885-7378 julesa@coreir.com | For investor inquiries: Scott Gordon for Alimera Sciences scottg@coreir.com |
FAQ
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