ILUVIEN has been launched for both Diabetic Macular Edema and Non-Infectious Posterior Uveitis Indications
ATLANTA, Dec. 09, 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 Irish subsidiary, has launched ILUVIEN® in the Netherlands. Alimera’s distribution partner Horus Pharma S.A.S. (Horus) has secured pricing and reimbursement and will begin selling ILUVIEN this month in the Netherlands for the treatment of diabetic macular edema (DME) and non-infectious uveitis affecting the posterior segment (NIPU).
“We are continuing to execute our strategy of geographic expansion, making ILUVIEN available for more physicians and patients in new markets,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “We are excited to work with our partner, Horus Pharma, who has been preparing for this launch of ILUVIEN over the past several months and is applying learnings from their highly successful launch in France.”
ILUVIEN is a sustained release intravitreal implant indicated in several European countries 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 anticipate a successful launch in the Netherlands as we expand our collaboration with Alimera Sciences for the marketing and distribution of ILUVIEN in another European territory,” said Maja Lausevic, Chief Operating Officer, Horus Pharma. “Access to ILUVIEN therapy and the benefits of its CONTINUOUS MICRODOSING™ technology is already broadly anticipated by local ophthalmologists. In fact, patients have already been scheduled for injection.”
“As a long-lasting steroid, ILUVIEN will be very useful for patients who suffer from DME and uveitis affecting the posterior segment,” said Prof. Carel B. Hoyng, Radboud University Medical Center, Nijmegen, The Netherlands. “Patients have been waiting for a long-lasting treatment and ILUVIEN provides an opportunity to decrease the burden of injections.”
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, which 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 non-infectious posterior uveitis (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. As solution makers, Horus Pharma is willing to help patients, physicians and pharmacists to find more suitable therapies. 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 sales 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’ and Alimera’s ability to successfully collaborate to expand distribution and sales and otherwise commercialize ILUVIEN in the Netherlands and the general acceptance by patients and physicians of ILUVIEN to treat DME and NIPU in the Netherlands, 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, June 30, 2020, and September 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.
|For press inquiries:
for Alimera Sciences
|For investor inquiries:
for Alimera Sciences