Three-Year Clinical Trial Results Support ILUVIEN® Launch in Europe for the Prevention of Relapse in Recurrent Non-Infectiou...
June 06 2019 - 8:00AM
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 Abrahamfor Alimera Sciences
917-885-7378julesa@coreir.com |
For investor inquiries:Scott Gordonfor Alimera
Sciences scottg@coreir.com |
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