Continued execution on strategy to grow international sales of ILUVIEN with new territory approvals, expanded reimbursement of posterior uveitis, and further market penetration
ATLANTA, Sept. 08, 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 the Scottish Medicines Consortium (SMC), after completing its assessment and review, has accepted (per label) ILUVIEN® for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU).
The decision came following a review of a cost-utility analysis for the prevention of relapse in recurrent non-infectious uveitis based on results from the PSV-FAI-001 clinical study. The analysis compared outcomes following insertion of a fluocinolone acetonide implant at baseline with standard treatment, including systemic corticosteroids or immunosuppressants, topical steroids, intraocular pressure reduction therapy, cataract removal and other elective ocular surgical procedures.
“ILUVIEN becoming available for treatment of NIU-PS through the NHS in Scotland is incredibly welcome news,” said Dr Mohan Varikkara, Consultant Ophthalmologist at University Hospital Ayr, Scotland. “It is good to have a treatment option that can be directly delivered into the eye which helps keep inflammation down to non-sight threatening levels. It is a long-acting implant which could potentially work for 3 years to prevent relapse and protect patients from further vision loss while also reducing the need for systemic medications, minimising their associated side effects and decreasing the need for regular blood monitoring, thus reducing the burden for patients.”
“This unrestricted reimbursement acceptance further reinforces the clinical value of ILUVIEN in the prevention of relapse, and control of the recurrence, of NIPU,” said Rick Eiswirth, President and Chief Executive Officer of Alimera. “We continue to execute on our goal of expanding ILUVIEN’s availability and are pleased that physicians and patients of the National Health Service Scotland now have access to ILUVIEN for both our NIPU and diabetic macular edema indications throughout the United Kingdom.”
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 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 Scottish Medicines Consortium
The Scottish Medicines Consortium is a committee of clinicians, pharmacists, National Health Service (NHS)) board representatives, the pharmaceutical industry and the public. Members of the committee consider a broad range of evidence in order to decide which medicines should be accepted for use by National Health Service Scotland.
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 contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995. 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, the willingness of physicians and patients in Scotland to adopt ILUVIEN for treatment of NIPU and the in-market experience of physicians and patients in using ILUVIEN to treat NIPU, 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 and June 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.
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