Alimera Highlights Abstracts Regarding Consensus Among US Retina Specialists and Reduced Retinal Thickness Variability Leading to Improved Visual Outcomes Following ILUVIEN® Administration
30 November 2022 - 12:00AM
Alimera Sciences, Inc. (Nasdaq: ALIM) (“Alimera”), a global
pharmaceutical company whose mission is to be invaluable to
patients, physicians, and partners concerned with retinal health
and maintaining better vision longer, announces findings from a
recent meeting where data demonstrated a high level of agreement
among retina specialists on the role of inflammation in the
pathophysiology of diabetic retinopathy (DR) and diabetic macular
edema (DME), injection burden and patient adherence, and efficacy
and safety of ILUVIEN® (fluocinolone acetonide intravitreal
implant) 0.19 mg sustained release intravitreal implant.
The company also announced analysis of data from
the 36-month PALADIN study that found 0.19 mg Fluocinolone
Acetonide (FAc) provides long-term reduction of retinal thickness
variability (RTV), which is correlated to improved visual outcomes
and better disease control. These results were made available at
the annual scientific meeting of The Retina Society held in
Pasadena, CA from November 2-5, 2022.
“We are excited to see a consensus in the retina
community on the increasing understanding of the role of
inflammation in diabetic eye disease, and the efficacy and safety
of ILUVIEN in treating DME,” said Rick Eiswirth, President and CEO
of Alimera. “We are also pleased to see the continuing impact of
the PALADIN Study of ILUVIEN, including another abstract presented
at the recent annual meeting of The Retina Society. The PALADIN
Study data presented demonstrates the correlation between reduced
RTV and better visual acuity, and the value of ILUVIEN’s CONTINUOUS
MICRODOSING™ in controlling RTV.”
Anton Kolomeyer, MD, PhD authored a poster titled,
“Fluocinolone acetonide and DME – An Expert Consensus.” To
understand the level of agreement among retinal physicians in the
US on the safety and efficacy of FAc in DME treatment, as well as
the role of inflammation in the pathophysiology of DR and DME,
researchers disseminated a survey to retina specialists. The full
survey was completed by 56 physicians. The modified Likert grading
scale was used to evaluate consensus.
Key Abstract Findings:
- A consensus was reached for seven of ten proposed statements.
These included those related to:
- Chronic low-grade inflammation and the associated inflammatory
cytokines (VEGF, IL-6, etc.) are key drivers of DR/DME
pathogenesis.
- Steroids have broad, non-specific anti-inflammatory properties,
including the downregulation of VEGF production.
- Chronic low-grade inflammation, a result of poor glycemic
control over time, can lead to neurodegenerative changes in the
diabetic retina.
- High injection burden tied to the use of short acting therapies
may lead to patient fatigue and lack of adherence, thereby limiting
treatment efficacy.
- High injection burden and poor patient adherence can lead to
increased amplitude and frequency of retinal fluctuations, which
may lead to irreversible vision loss in some patients.
- The 0.19 mg fluocinolone acetonide implant can minimize retinal
thickness fluctuations and reduce treatment burden through
continuous and consistent treatment over 36 months.
- IOP elevation associated with the 0.19 mg fluocinolone
acetonide implant is manageable in the majority of cases with
topical IOP lowering therapy.
- Although below the consensus threshold, physicians were in high
agreement that “the 0.19 mg fluocinolone acetonide implant may
represent a viable treatment option to establish early baseline
control of the underlying low-grade, chronic inflammatory disease
in patients with DR/DME,” and 93% of clinicians identified at least
one clinical situation in which they would consider the use of
steroids as baseline therapy.
Veeral Sheth, MD, MBA presented the abstract
titled, “The 0.19 mg Fluocinolone Acetonide (FAc) Implant Reduces
the Recurrence of Edema by Providing Long-Term Control of Retinal
Thickness Variability in Patients with DME: The 3-Year PALADIN
Study.” According to the abstract, data from the PALADIN phase IV,
real world observational study support that the FAc implant
significantly reduces RTV through reduction of the recurrence of
edema. The authors point out that no new safety signals were
identified during the Study, and they highlight the FAc implant as
the only long-term therapy providing consistent control of RTV in
patients with DME.
Key Abstract Findings:
- FAc provides reduction of RTV for up to 36 months
- Reduced RTV is correlated to improved visual outcomes and
better disease control
- Eyes in which RTV was best controlled (Q1 & Q2) post-Fac,
demonstrated significant gains in BCVA
- The 0.19 mg FAc implant provides a durable treatment option
that can reduce the burden of care for patients with DME
About PALADIN The
PALADIN study was a phase 4, open-label, prospective,
observational study conducted over 36 months at 41 sites across the
United States. This study was designed and developed to
confirm the benefit of using a prior course of corticosteroid as
indicated in the ILUVIEN U.S. label, to mitigate the risk of
uncontrolled IOP elevation. Researchers enrolled 202 eyes in
159 patients with DME who had previously received
corticosteroid treatment without a clinically significant rise in
IOP. All eyes were treated with ILUVIEN and patients were
followed for up to 36 months. Additionally, secondary outcomes
confirmed improvement in vision and reduction in treatment burden
and retinal thickness variability.
About ILUVIEN www.ILUVIEN.com The
Company’s sole 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 and number of
treatments required, enabling patients to maintain vision longer
with fewer injections. ILUVIEN® (fluocinolone acetonide
intravitreal implant) 0.19 mg is indicated in the U.S. for the
treatment of 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. For
safety information please
visit https://iluvien.com/#isi and scroll down the
page.
About Alimera Alimera is a global
pharmaceutical company whose mission is to be invaluable to
patients, physicians, and partners concerned with retinal health
and maintaining better vision longer. For more information, please
visit www.alimerasciences.com.
For press
inquiries: Cassy Dump for Alimera 619-971-1887
cassy.dump@precisionvh.com |
For investor
inquiries: Scott Gordon for Alimera scottg@coreir.com |
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