Alimera Sciences Receives Acceptance of Filing to Obtain Approval for ILUVIEN® Non-Infectious Posterior Uveitis Indication in Europe
“We are very pleased to have filed for this variation in 2017 ahead of schedule,” said
Alimera submitted the results from two, randomized, double-masked, multi-center phase 3 clinical trials, with the primary endpoint at six months comparing the proportion of patients who do not experience a recurrence of NIU-PS. In both studies, the primary endpoint was met.
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, which is a leading cause of blindness in the 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 posterior uveitis are typically treated with systemic steroids, which are very 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 themselves can have severe side effects, including an increased risk of cancer and infections.
One problem for patients and clinicians is that recurrence of uveitis is very common. In chronic uveitis, recurrence often occurs within six months of withholding treatment, and patients and clinicians are forced to go through cycles of treatment initiation and cessation with the accompanying complexity of managing several drug classes, and their side effects, at once.
For patients with recurring or chronic uveitis, locally delivered (intravitreal) steroids present an attractive treatment strategy, which allows for effective delivery of steroid at the point of need, while minimizing the risk of systemic side effects. ILUVIEN has been shown in clinical trials to significantly reduce the recurrence of non-infectious uveitis and accompanying vision loss, while at the same time reducing the need for systemic drug treatment.
ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained release intravitreal implant indicated in
The seventeen countries reviewing the submission are the
Alimera, founded in June 2003, 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 will affect millions of people in our aging populations. Alimera’s commitment to retina specialists and their patients is manifest in Alimera’s product and development portfolio designed to treat early- and late-stage diseases. 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, the availability of ILUVIEN to patients with uveitis in
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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Source: Alimera Sciences, Inc.