Navigation Links
Alimera Reports Favorable Safety and Efficacy Results From the 12-Month Interim Readout of the Human PK Iluvien(TM) Study
Date:3/12/2009

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
'/>"/>

SOURCE Alimera Sciences, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien(TM) Study
2. DSMB Again Supports Continuation of Alimera Sciences Phase 3 Clinical Trial of Iluvien(TM) for the Treatment of DME
3. Alimera Reports Results From the Three-Month Interim Readout of the Human PK Medidur(TM) FA Study
4. Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient
5. Isolagen, Inc. Reports Positive Top-line Results from Phase II/III Study of Isolagen Therapy(TM) to Treat Moderate to Severe Acne Scars: Study Meets All Primary Efficacy Endpoints and is Statistically Significant
6. Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data on KRX-0401 (Perifosine) in Combination with Bortezomib (+/- Dexamethasone) at the 12th International Multiple Myeloma Meeting
7. ExonHit Therapeutics Reports Advancements in the Clinical Development of EHT 0202, its Phase II Drug for Alzheimers Disease
8. Novavax Reports Positive Preclinical Results for a Novel, Broadly Cross-Protective H5N1 Pandemic Influenza Virus-like Particle (VLP) Vaccine Candidate
9. Rosetta Genomics Reports First Ever In-Vivo Efficacy Data for a Systemic MicroRNA Therapeutic for Liver Cancer
10. Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports
11. Pieris Reports Development Progress for Anticalin(R) PRS-050, a Next Generation VEGF Antagonist
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/16/2015)... Mindray Medical International Limited (NYSE: MR ... medical devices worldwide, announced today that it has ... Report on Form 20-F that included audited financial ... electronic version of Mindray,s Annual Report on Form ... at  http://ir.mindray.com  or  http://www.sec.gov . Investors ...
(Date:4/16/2015)... MOUNTAIN VIEW, Calif. , April 16, 2015  Alexza ... its fiscal quarter ended March 31, 2015 on Wednesday, May ... The Company will also host an investor conference call and ... Time to provide a company update and discuss the financial ... Internet, go to www.alexza.com , under the "Investors" link.  ...
(Date:4/16/2015)... , April 16, 2015 Today, Kenneth C. ... & Co., Inc., was elected chairman of the Board of ... Board meeting, PhRMA,s president and CEO John J. Castellani ... 2016.  New Officers Elected to PhRMA Board ... succeeds Ian C. Read , chairman and CEO of ...
Breaking Medicine Technology:Mindray Files Annual Report on Form 20-F with the U.S. Securities and Exchange Commission 2Alexza to Report 2015 First Quarter Financial Results and Provide Corporate Update on Wednesday, May 6, 2015 2Alexza to Report 2015 First Quarter Financial Results and Provide Corporate Update on Wednesday, May 6, 2015 3Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 2Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 3Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 4Merck Chairman and CEO Kenneth C. Frazier Becomes PhRMA Board Chairman 5
... 2012   Psyche Systems Corporation and Aperio ... offer the most advanced anatomic pathology information system ... pathologists can immediately access, manage, and evaluate their ... LIS via intuitive step-by-step workflows. ...
... treatment of the fermented soy germ-based nutritional supplement containing ... cholesterol and improved vascular stiffness, all factors that occur ... peer-reviewed study reported in a poster at the Women,s ... the first to provide evidence that a daily supplement ...
Cached Medicine Technology:Psyche Systems Corporation and Aperio® Announce Availability of Their Fully Integrated Anatomic Pathology System 2Soy-Based S-equol Supplement Reduces Metabolic Syndrome Risk Factors 2Soy-Based S-equol Supplement Reduces Metabolic Syndrome Risk Factors 3Soy-Based S-equol Supplement Reduces Metabolic Syndrome Risk Factors 4Soy-Based S-equol Supplement Reduces Metabolic Syndrome Risk Factors 5
(Date:4/17/2015)... California (PRWEB) April 17, 2015 At ... Entertainment’s EcoLuxe Lounge and the “Salute to the Oscars” ... luxurious Beverly Hilton Hotel, overlooking the impressive Los Angeles ... were organized by Debbie Durkin, LA’s leading producer of ... Showcasing many of the world’s premier providers of eco-friendly ...
(Date:4/17/2015)... 2015 Baptist Health and The University ... partnership agreement designed to transform oncology care in northeast ... agreed to create a joint cancer program to enhance ... research. Baptist MD Anderson Cancer Center is anticipated to ... destination for highly coordinated, multidisciplinary cancer care for adults ...
(Date:4/17/2015)... 17, 2015 The American College of Traditional Chinese ... Application Day on April 29. The event will be held from ... at 555 DeHaro St. in San Francisco, CA. , The agenda ... in at the DeHaro campus (room F), 11:10 a.m. – ... Noon – Light lunch with current students, faculty and staff, 1 ...
(Date:4/17/2015)... Compare-autoinsurance.org has released a new blog post explaining ... quotes . , The online environment can help ... Drivers should always compare multiple car insurance policies before ... a competitive one, which means that customers can find ... is now possible to compare online car insurance quotes ...
(Date:4/17/2015)... Lowcostcarinsuranceprice.com has released a new blog post explaining the ... car insurance rates . , Falling asleep at ... have a big impact on auto insurance prices. The premiums ... claimed benefits. The newly released blog post talks more about ... , It is now possible to find low cost ...
Breaking Medicine News(10 mins):Health News:Choices Recovery Speaks with Dakota Hood of “The Hunger Games” about Addiction in Hollywood 2Health News:Baptist Health and MD Anderson Finalize Agreement to Transform Cancer Care in Region 2Health News:Baptist Health and MD Anderson Finalize Agreement to Transform Cancer Care in Region 3Health News:American College of Traditional Chinese Medicine Hosts Open House 2Health News:The Best Auto Insurance Quotes Are Available Online! 2Health News:Accidents Caused By Sleeping at The Wheel Can Increase Auto Insurance Costs 2
... 30 (HealthDay News) -- Genes affect hereditary coronary heart disease ... study. While it,s long been known that hereditary factors ... due to genes or unhealthy lifestyle in the family, the ... the investigators examined the health records of 80,214 adopted men ...
... It,s not how old but how frail patients are that can ... fact, young patients in poor health may have worse outcomes than ... the University of Michigan Comprehensive Cancer Center finds that patients with ... spread to distant parts of the body. These findings ...
... found that climate change may lead to more asthma-related health ... the next decade. The data, published in the current ... changing levels of ozone could lead to a 7.3 percent ... The research team, led by Perry Sheffield, ...
... 2011Despite recent concerns that changes in atmospheric pressure during ... via pump devices, the current evidence is limited and ... are available, according to an insightful editorial in ... by Mary Ann Liebert, Inc. The editorial is available ...
... by extroverted college students and their less socially inclined peers ... on partying and drinking to be happy and more on ... positive thinking. "You don,t have to go out ... they need to do, particularly when they,re new to campus," ...
... HealthDay Reporter , TUESDAY, Aug. 30 (HealthDay News) -- Swedish ... seems to be a harbinger of an increased risk of ... strongly tied to the inflammatory processes that are central to ... of the new study, published online Aug. 30 in the ...
Cached Medicine News:Health News:Patients' underlying health linked to worse outcomes for melanoma, U-M study finds 2Health News: Happiness: All in who you know, goals 2Health News:Blood Protein Might Signal Death Risk in Elderly 2
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: