Three-Year Clinical Trial Results Support ILUVIEN® Launch in Europe for the Prevention of Relapse in Recurrent Non-Infectious Uveitis Affecting the Posterior Segment
A single ILUVIEN implant significantly delayed recurrence and reduced uveitis symptoms upon recurrence compared to active control arm
Recently approved in
“These data demonstrate the clinical importance of ILUVIEN as a new treatment option for non-infectious uveitis of the posterior segment, with the ability to significantly reduce disease recurrence in patients for up to 36 months while providing a much longer time to first recurrence as well as less severity of recurrence in most patients,” said Mr.
In the 129-patient prospective, randomized and masked clinical trial, patients received a single ILUVIEN implant or an active control sham injection, and recurrence of NIPU was assessed based on the observation of specified NIPU symptoms or by active treatment by clinicians.
- The median time to first recurrence of NIPU was significantly longer in the ILUVIEN arm of the trial (657 days/94 weeks), compared to the control sham arm (70.5 days/10 weeks) (p<0.001).
- The number of recurrences of uveitis was significantly lower in the ILUVIEN arm (1.7) vs the sham arm (5.3) over the 36 months (p<0.001).
- There was a significantly greater improvement (p = .020) from baseline in Best Corrected Visual Acuity (BVCA) in the ILUVIEN treated arm (+9.1 letters) compared to sham (+2.5 letters).
- IOP was well-controlled in both arms, mainly by IOP-lowering medication.
- Patients treated with ILUVIEN had a lower rate of surgery to reduce severe IOP compared to sham (5.7% vs 11.9%), and a higher rate of cataract surgery compared to sham (73.8% vs 23.8%)
“We are very pleased that ILUVIEN’s CONTINUOUS MICRODOSING™ technology not only reduces the recurrence of diabetic macular edema but can provide important and sustained benefits in patients diagnosed with non-infectious posterior uveitis,” said
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 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.,
See www.ILUVIEN.com for important safety information.
Alimera, founded in
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 can provide long-lasting relief and vision-sparing benefits to patients with a single intra-ocular injection in
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Source: Alimera Sciences, Inc.