NICE decision is key milestone expanding access to patients in the United Kingdom
ATLANTA, June 20, 2019 (GLOBE NEWSWIRE) -- Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a leader in the commercialization and development of prescription ophthalmology treatments for the management of retinal diseases, announces that the United Kingdom'sNational Institute for Health and Care Excellence (NICE), in its Final Appraisal Determination for national reimbursement, has recommended funding for ILUVIEN 190 micrograms intravitreal implant in applicator for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment (NIPU).
“The NICE coverage decision for ILUVIEN is welcome news for patients in the U.K. suffering from this disease, as reducing relapse is a priority in the management of this condition,” said Mr. Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist at Moorfields Eye Hospital, London, U.K. “Preventing vision loss associated with relapse has a huge impact on patients’ quality of life.”
In the United Kingdom, a NICE recommendation for funding signifies that the country’s National Health Service (NHS) will pay for ILUVIEN prescriptions for the treatment of NIPU as part of its offering. ILUVIEN is also funded for the treatment of diabetic macular edema (DME) in the United Kingdom. More information on the recommendation can be found on the NICE website at https://www.nice.org.uk/news/article/innovative-treatment-for-inflammatory-eye-condition-recommended-for-use-on-the-nhs.
"The Birdshot Uveitis Society and our members are delighted that NICE has approved the ILUVIEN implant for use in posterior uveitis patients," said Annie Folkard, founding member of The Birdshot Uveitis Society. “It is a very welcome development as this slow-release steroid implant offers a very effective treatment directly targeting inflammation in the eye without a lot of the unpleasant side effects of more systemic drugs that have been frequently used in the past.”
See www.ILUVIEN.com for important safety information.
“We continue to execute on our plans to launch ILUVIEN’s new indication in Europe for non-infectious posterior uveitis, a significant and, we believe, poorly-served medical need. The positive funding recommendation from NICE facilitates patient access in England and Wales for this second indication with funding from the NHS,” said Rick Eiswirth, president and CEO of Alimera Sciences. “ILUVIEN’s unique CONTINUOUS MICRODOSING™ technology provides important sustained benefits in patients diagnosed with both posterior uveitis and DME, and we are pleased to work with physicians and the National Health Service in the U.K. to expand its availability.”
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 control 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.
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 provides unique and important sustained benefits in patients diagnosed with both posterior uveitis and DME, that ILUVIEN will launch as planned in the U.K and that this positive recommendation from NICE will facilitate access to ILUVIEN for NIPU. 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.
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Source: Alimera Sciences, Inc.