Navigation Links
Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study

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

SOURCE Alimera Sciences, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. DSMB Again Supports Continuation of Alimera Sciences Phase 3 Clinical Trial of Iluvien(TM) for the Treatment of DME
2. Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
3. BioView Reports Interim Results of Early Detection Lung Cancer Diagnostic Test
4. Bioheart Reports Promising Results From Preclinical Study of Adipose-Derived Acute Cell Therapy
5. MannKind Reports Positive Data from a Phase 3 Clinical Study of Technosphere Insulin in Type 1 Diabetes
6. Bionovo Reports on Metabolic Studies Related to Its Menopausal Hot Flash Drug Candidate
7. Nutrition 21 Reports That National Toxicology Program Studies Support the Safety of Chromium Picolinate
8. Human Genome Sciences Reports Initial Results of Randomized Phase 2 Trial of HGS-ETR1 in Combination With Bortezomib in Advanced Multiple Myeloma
9. Regado Biosciences Reports Clinical Results for REG1 Anticoagulation System at European Society of Cardiology Congress 2008
10. Algeta Reports Positive Headline Phase II Data on Pain Palliation With Alpharadin
11. Pharmasset Reports Financial Results for Quarter Ended June 30, 2008
Post Your Comments:
(Date:11/25/2015)... 2015 AAIPharma Services Corp./Cambridge Major Laboratories, ... least $15.8  Million to expand its laboratories and ... . The expansion will provide additional office space ... demands of the pharmaceutical and biotechnology markets. ... provide up to 40,000 square feet of expanded ...
(Date:11/25/2015)... , Nov. 25, 2015  ARKRAY USA ... continues to provide evidence demonstrating the accuracy of its ... Congress on Insulin Resistance, Diabetes and Cardiovascular Disease in ... both the Company,s GLUCOCARD ® 01 meter and ... accuracy requirements. The ability to accurately measure glucose levels ...
(Date:11/25/2015)... 25, 2015 Kitov Pharma ... KTOV), a biopharmaceutical company focused on the development of ... conditions, today announced the closing of its previously announced ... ADSs ), each representing 20 ordinary shares of the ... The ADSs and warrants were issued in a fixed ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... The moment you stop improving is the ... the needs of advisers and clients but going above and beyond to find ... service. However, there's always room for improvement, which is why the entire Consulting ...
(Date:11/27/2015)... ... 2015 , ... CBD College is proud to announce that on ... accreditation to its Diagnostic Medical Sonography program. CBD College is honored to join this ... colleges and universities in the state of California make the cut. CBD College is ...
(Date:11/27/2015)... ... 2015 , ... Dr. Thomas Dunlap and Dr. Patrick Coleman ... with Emergency Medicine at St., Joseph Health System’s Santa Rosa Memorial Hospital , ... in similar ways and require time-critical intervention to avoid large area heart damage and ...
(Date:11/27/2015)... ... ... Indosoft Inc., developer and distributor of the world-class Asterisk ... Term Support) into its Q-Suite 5.10 product line. , Making the change to ... of Asterisk that will receive not only security fixes, but feature and bug ...
(Date:11/26/2015)... ... 2015 , ... Inevitably when people think Thanksgiving, they also think Holiday sales ... Black Friday and Cyber Monday massage chair sales to receive the best ... low to find the best massage chair deals, they can see all of the ...
Breaking Medicine News(10 mins):