Alimera Sciences Reports Favorable Safety and Efficacy Results From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study
ATLANTA, March 12 /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 12-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien(TM). Iluvien is an intravitreal insert being developed for the treatment of diabetic macular edema (DME).
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 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).
In the 12-month interim readout, no adverse events related to intraocular pressure (IOP) were seen in low dose patients, and 23.5 percent of the high dose patients experienced IOP increases of 30 millimeters of mercury (mmHg) or greater at some time point. By way of comparison, in published results from clinical studies of DME patients using sustained release intravitreal FA in Bausch & Lomb Incorporated's product Retisert(R), a surgically implanted intravitreal drug delivery device containing 0.59 mg FA approved for the treatment of chronic non-infectious posterior uveitis, 35 percent of the patients experienced IOP increases of 30 mmHg or greater at some time point during the first year.
"This profile of IOP changes occurring only in the high dose group is consistent with the IOP change profiles that were seen at the three and six month readouts," said Ken Green, Ph.D., Chief Scientific Officer of Alimera Sciences. "Given the lower incidence of IOP changes of 30 mmHg or greater observed with Iluvien, as compared to published clinical data on Retisert, Iluvien may offer an important safety advantage in the delivery of FA."
From an efficacy perspective, data from the subgroup of patients that reflect the same visual acuity inclusion criteria as that of the larger Phase 3 FAME trial being conducted by Alimera, revealed that 27.3 percent of the high dose patients had an improvement in best corrected visual acuity (BCVA) of 15 letters or greater over baseline and 23.1 percent of the low dose patients had an improvement in BCVA of 15 letters or greater over baseline.
"We are pleased by the strong 15-letter results in both doses as subject follow up continues," said Dan Myers, President and Chief Executive Officer of Alimera Sciences. In the Retisert DME trials, visual acuity continued to improve over the second year, giving us great encouragement for future interim looks at the Iluvien data. Overall, the results in this small study continue to be in line with our expectations regarding the safety and efficacy of Iluvien."
Data from the PK Study will continue to be evaluated with interim looks at months 18, 24, 30 and 36. Except for the month 18 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 Iluvien(TM)
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 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.
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.
CONTACT: Keith Aikens of Fleishman-Hillard, +1-404-739-0137,
keith.aikens@fleishman.com, for Alimera Sciences