ATLANTA, Oct. 1 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported the interim month six safety and efficacy results from the first human pharmacokinetic (PK) study of Iluvien(TM).
Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (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 36 months for the low dose and up to 24 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 36-month, open-label, Phase 2 PK study, running concurrently with the pivotal Phase 3 FAME(TM) Study of Iluvien (Fluocinolone Acetonide in Diabetic Macular Edema), is designed primarily to assess systemic exposure of the corticosteroid, fluocinolone acetonide, after administration of Iluvien in patients with DME. Secondarily, the PK study is designed to provide information on the safety and efficacy of Iluvien in a DME patient population. A total of 37 subjects were enrolled in the PK study, 20 patients on the low dose of Iluvien (an approximate 0.23 micrograms per day dose), and 17 patients on the high dose of Iluvien (an approximate 0.45 micrograms per day dose).
The six-month interim readout from the PK study showed 18 percent of the high dose patients had an improvement in best corrected visual acuity (BCVA) of 15 letters or greater over baseline. This is consistent with the three- month readout. The percentage of low dose patients that had an improvement in BCVA of 15 letters or greater from baseline decreased from 20 percent at the three-month readout to 10 percent because one patient developed a cataract and one patient developed an epiretinal membrane involving the macula prior to the readout. The development of cataracts and epiretinal membranes in a diabetic population are not unusual and are commonly addressed with surgical intervention.
In addition, the six-month readout showed 25 percent of the low dose patients and 41 percent of the high dose patients had an improvement in BCVA of 10 letters or greater from baseline. This is an improvement from the three-month data where 20 percent of low dose patients and 29 percent of high dose patients had gained more than 10 letters compared to baseline.
"It is very encouraging that the number of patients with greater than 10-letter improvement has increased for both doses when comparing the six- month data to the three-month data," said Ken Green, Ph.D., chief scientific officer of Alimera.
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 30 mmHg or greater at some time point. Further, 10 percent of the low dose patients and 12 percent of the high dose patients reported an adverse event related to cataract formation, and one additional patient in each dose group underwent a cataract extraction.
"The six-month readout from the Iluvien PK study continues to support the premise that corticosteroids, delivered in low doses in a consistent and sustained manner directly into posterior segment of the eye, can be an efficacious treatment for DME," said Dan Myers, president and CEO of Alimera Sciences, "We are also pleased with Iluvien's safety profile as evidenced by the low IOP rates and the lack of filtration procedures at the month 6 time point."
Data from the PK Study will continue to be evaluated with interim looks at months 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 2008.
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 acquired options to exclusive, worldwide licenses for two classes of nicotinamide adenine dinucleotide phosphate reduced form (NADPH) oxidase inhibitors, which Alimera is studying 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 has exercised its option to acquire a license with respect to one of these classes of NADPH oxidase inhibitors.
For more information on Alimera Sciences, visit http://www.alimerasciences.com.
CONTACT: Katie Brazel of Fleishman-Hillard, +1-404-739-0150,
katie.brazel@fleishman.com, for Alimera Sciences, Inc.
Web site: http://www.alimerasciences.com/
