Second country in Europe where patients now have access to this important new treatment option; marketing to commence immediately
ATLANTA, Sept. 03, 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 will immediately commence the launch of ILUVIEN in Germany for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). Following the European Union’s Mutual Recognition Procedure in March 2019, Germany is the second country in Europe in which ILUVIEN is now commercially available to be prescribed to patients suffering from NIPU, a disease with no sustained treatment options. In June 2019, Alimera announced a positive recommendation by the National Institute for Health and Care Excellence (NICE), facilitating launch of the NIPU indication in the United Kingdom.
“New therapeutics for non-infectious uveitis are urgently needed, as there are few options available while potential for vision loss is very real. The availability of ILUVIEN now provides a long-acting, intravitreal treatment option for our patients that closes a gap in the care needs of this chronic disease,” said Professor Dr. med. Carsten Heinz FEBO, Augenzentrum am St. Franziskus-Hospital, Munster, Germany. “ILUVIEN has a well-established efficacy and safety profile for the continuous treatment of diabetic macular edema and now patients with non-infectious uveitis affecting the posterior segment can expect similar benefits and - due to the local application – no occurrence of the unwanted systemic effects of long-term corticosteroid therapy.”
Launch of the NIPU indication follows the establishment of national pricing and receipt of the required regulatory approval by the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM), the medical regulatory authority in Germany. Germany is Alimera’s largest direct market in Europe based on current sales for ILUVIEN’s diabetic macular edema (DME) indication, and it is estimated that the number of patients diagnosed with NIPU is approximately 15-20% of the DME patient population.
“The launch in Germany represents our second country rollout for ILUVIEN’s expanded European indication for uveitis, a retinal disease that anti-VEGF drugs do not treat,” said Rick Eiswirth, president and CEO of Alimera Sciences. “We continue to receive encouraging feedback from physicians regarding ILUVIEN’s unique CONTINUOUS MICRODOSING™ technology, with its ability to reduce the recurrence of disease in patients diagnosed with either non-infectious posterior uveitis or DME.”
About Non-Infectious Posterior Uveitis
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 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.
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 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, 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 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 these diseases are not well treated with current therapies and will affect millions of people in our 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 ILUVIEN’s CONTINUOUS MICRODOSING technology has the ability to reduce the recurrence of disease in patients diagnosed with non-infectious posterior uveitis or DME, and that ILUVIEN will launch as planned in Germany. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change either of them, and could cause actual results to differ materially from those projected in its 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.