Alimera Sciences, Inc., a privately
held biopharmaceutical company that specializes in the research,
development and commercialization of prescription ophthalmic
pharmaceuticals, reported the interim month three safety and efficacy
results from the first human pharmacokinetic (PK) study of Medidur(TM) FA,
which Alimera Sciences intends to market under the tradename Iluvien(TM),
if approved by the U.S. Food and Drug Administration.
This 36-month, open-label Phase 2 study, running concurrently with the
pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular
Edema), is designed primarily to assess systemic exposure of the
corticosteroid, fluocinolone acetonide (FA), after administration of
Iluvien in diabetic macular edema (DME) patients. Secondarily, the study is
designed to provide information on the safety and efficacy of Iluvien in a
DME population. A total of 37 subjects were enrolled in this trial, 20
patients on the low dose (an approximate 0.23 microgram per day dose) of
Iluvien, and 17 patients on the high dose (an approximate 0.45 microgram
per day dose) with the same inclusion/exclusion criteria as the ongoing
Phase 3 FAME Study.
Iluvien is an intravitreal insert being developed for the treatment of
DME. DME is a disease of the retina, which affects individuals with
diabetes and can lead to severe vision loss and blindness. Each Iluvien
insert is designed to provide a sustained therapeutic effect, up to 24
months for the low dose and up to 36 months for the high dose. Iluvien is
inserted into the patient’s eye with a 25-gauge needle, which allows for a
self-sealing wound. This insertion is very similar to an intravitreal
injection, a procedure commonly employed by retinal specialists.
This three-month interim readout from the PK Study indicated 20 percent
of the low dose patients and 18 percent of the high dose patients showed an
improvement in best-corrected visual acuity (BCVA) of 15 letters or greater
from baseline. In addition, both the low dose and the high dose of Iluvien
resulted in a significant reduction in retinal thickness as compared to the
baseline.
From a safety perspective, no adverse events related to intraocular, or
inner eye, pressure were seen in the low dose patients, while 12 percent of
the high dose patients experienced intraocular pressure increases of
greater than 30 mmHg. Additionally, the only adverse event related to
cataract formation was reported in a patient in the high dose group.
The early readout from this PK Study provides further insight into the
dose-response of FA in the treatment of DME. By comparison, Bausch & Lomb’s
Retisert(R) (fluocinolone acetonide intravitreal implant), with an initial
release dose of 0.6 microgram per day, was also studied in a DME
population. It demonstrated a significant improvement in visual acuity at
one year, comparable to the Iluvien results reported here; however, a lower
dose was not tested. Therefore, it has not been determined if Retisert’s
dosage level represents the lowest efficacious dose for DME.
“We believe this early readout from our PK Study supports our premise
that lower doses of FA delivered by Iluvien will provide visual acuity
improvements while reducing the risk of ocular side effects commonly
associated with the use of corticosteroids,” said Ken Green, Ph.D., chief
scientific officer for Alimera.
Data from this open-label study will be evaluated on an ongoing basis
with interim looks at months 3, 6, 12, 18, 24, 30 and 36. Except for the
month 12 and final month 36 looks, when the database will be fully locked,
interim evaluations will be based on unaudited data. The last patient was
enrolled in this study at the end of February 2007.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in the
research, development and commercialization of prescription ophthalmic
pharmaceuticals. Presently the company is focused on diseases affecting the
back of the eye, or retina. Its most advanced product candidate is
Iluvien(TM), which is being developed for the treatment of diabetic macular
edema, or DME. DME is a disease of the retina, which affects individuals
with diabetes and can lead to severe vision loss and blindness. Under one
protocol, enrollment was completed in October 2007 in two Phase 3 pivotal
trials for the use of Iluvien in the treatment of DME conducted across the
U.S., Canada, Europe and India, with a combined total enrollment of 956
patients.
Alimera also has entered into an exclusive worldwide agreement with
Emory University to explore oxidative stress management — specifically the
reduction of reactive oxygen species (ROS) — as a treatment strategy for
ophthalmic diseases. Under this agreement, Alimera has the exclusive option
to license compounds, which are NADPH (nicotinamide adenine dinucleotide
phosphate reduced form) oxidase inhibitors, as potential treatments for
conditions such as the dry form of age-related macular degeneration (AMD),
particularly the late stage of this condition known as geographic atrophy.
Alimera retains the right to use the Medidur(TM) delivery system for two of
these compounds, and is also exploring other delivery technologies to apply
to these compounds.
Alimera Sciences, Inc.
alimerasciences