Loading, Please Wait...

CST: 22/08/2019 14:13:25   

Three-Year Clinical Trial Results Support ILUVIEN® Launch in Europe for the Prevention of Relapse in Recurrent Non-Infectious Uveitis Affecting the Posterior Segment

77 Days ago

A single ILUVIEN implant significantly delayed recurrence and reduced uveitis symptoms upon recurrence compared to active control arm

Recently approved in Europe, ILUVIEN is expected to launch in certain EU countries during the second half of 2019

ATLANTA, June 06, 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 three-year follow-up data from the Phase 3 clinical trial for ILUVIEN 190 micrograms intravitreal implant in applicator, for the prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye (NIPU). The data will support the Company’s planned launch of ILUVIEN for the NIPU indication in Europe during the second half of 2019.

“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. Carlos Pavesio, Specialist Uveitis Consultant Ophthalmologist at Moorfields Eye Hospital, London, U.K.

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 Rick Eiswirth, president and CEO of Alimera Sciences. “As we approach the launch of ILUVIEN for posterior uveitis in our key direct markets of Germany and the U.K., we wanted to communicate these important results as we believe this new treatment can provide long-lasting relief and vision-sparing benefits to patients with a single intra-ocular injection.”

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.

About ILUVIEN

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 UK, 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.

www.alimerasciences.com

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 can provide long-lasting relief and vision-sparing benefits to patients with a single intra-ocular injection in Europe and that it will be launched in certain EU countries in the second half of 2019. 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.

For press inquiries:
Jules Abraham
for Alimera Sciences
917-885-7378
julesa@coreir.com

 
For investor inquiries:
Scott Gordon
for Alimera Sciences
scottg@coreir.com

 

Is your business listed correctly on America’s largest city directory network of 1,000 portals?