Navigation Links
Pilot Study to Assess Safety and Efficacy of Medidur(TM) FA in AMD Patients Treated With Lucentis(R)
Date:5/8/2008

ATLANTA, May 8 /PRNewswire/ -- Alimera Sciences Inc., a privately held ophthalmic pharmaceutical company announced today that enrollment has begun for a pilot study to assess the safety and efficacy of Medidur FA in conjunction with Lucentis(R) (ranibizumab injection, Genentech) in patients with exudative age-related macular degeneration (wet AMD).

This pilot study, which will be performed under an investigator sponsored IND, will compare two doses of Medidur FA (0.2 and 0.5 ug/day) in patients who have been treated with Lucentis for at least six months. The change from baseline in parameters such as visual acuity and retinal thickness will be assessed, in addition to comparing the number of Lucentis injections post- randomization versus pre-randomization. It has been previously shown that Lucentis requires persistent dosing to maintain efficacy.

"Alimera Sciences is pleased to support this study design because it will provide preliminary information on the potential of Medidur FA to maintain the efficacy established with Lucentis while reducing the number of Lucentis treatments," said Dr. Ken Green, Senior VP and Chief Scientific Officer for Alimera Sciences.

Lucentis is an antibody that binds to VEGF, thus preventing it from interacting with its receptor and causing additional damage in patients with wet AMD. Corticosteroids inhibit VEGF secretion in addition to their anti- inflammatory action and ability to suppress leukostasis. Given these complementary actions, the concomitant use of Lucentis and Medidur is warranted in patients being treated with Lucentis for wet AMD.

AMD is a degenerative disease of the central portion of the retina (the macula) which typically occurs in patients over the age of 50. One form of the disease, exudative (or wet) AMD is characterized by the formation of leaky new blood vessels originating in the choroid which may hemorrhage and cause accumulation of sub- and intra-retinal fluid. This form of AMD accounts for the majority of cases of severe vision loss. Medidur FA, a tiny, injectable intravitreal insert, is currently being studied as a way to deliver a very low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME) in the FAME Phase III clinical trial. Using a proprietary 25 gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.

About Alimera Sciences Inc.

Alimera Sciences Inc. is singularly focused on the development and commercialization of prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences' products are focused on improving the delivery of therapeutic agents to enhance patients' lives and strengthen physicians' ability to manage ocular conditions.

Alimera completed enrollment in October 2007 of its 956-patient Phase III clinical trial of fluocinolone acetonide in the Medidur(TM) drug delivery system for the treatment of diabetic macular edema. Alimera has 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 for ophthalmic diseases. The agreement gives Alimera 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 delivery system for two of these compounds.


'/>"/>
SOURCE Alimera Sciences Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Pilot study reinforces use of portable anteroom HEPA filtration
2. Phyhealth Signs Agreement with Advantica EyeCare to Provide Vision Services for Pilot HMO
3. Lake Hospital System Selected as Pilot Site for Health Information Literacy Research Project
4. NovoCure presents results from breast cancer pilot study
5. Researchers pilot new electronic system for infectious illness
6. VA to Pilot Innovative Remote Benefits Delivery Program
7. Phyhealth Concludes $1.5 Million Financing for Launch of Its Pilot Community-Based HMO
8. GHI and HIP Launch Pilot Medical Home Network Project with Support from Commonwealth Fund
9. Rockefeller Universitys Center for Clinical and Translational Science funds pilot studies
10. Pilot error declines as factor in airline mishaps
11. GDAHC Save Lives Save Dollars Initiative Launches Pilot Program for Diabetes Care Management
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... Healthcare Research & Analytics® ... the fight against cancer, has produced a seminal study that asked cancer survivors ... top-line findings in a webinar, Defining Compassionate Care Through the Voices of Patients ...
(Date:2/23/2017)... ... (PRWEB) February 23, 2017 -- ... to come together to combine its favorite springtime pastime – ... fruit – apples! To celebrate National Nutrition Month, the U.S. ... Madness” bracket tournament – a five-week, five-round online competition spotlighting ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... Top cosmetic ... Smiling Patriot program today with a new Indiegogo campaign . Individuals are ... homeless veterans in the Los Angeles area, either as a participating patient or through ...
(Date:2/23/2017)... , ... February 23, 2017 , ... HealthPostures, the desk ... an expert sit stand solutions representative to the Minneapolis Home and Garden Show which ... the event that is garnering national attention is the Minneapolis Convention Center. , ...
(Date:2/23/2017)... (PRWEB) , ... February 23, 2017 , ... Carlos ... problems. He has also continued to spiritually evolve, which is the purpose of everyone ... “ Our Spiritual Truths ” (published by Balboa Press) attempts to guide readers to ...
Breaking Medicine News(10 mins):
(Date:2/23/2017)... York , February 23, 2017 ... Holter Monitor Market are GE Healthcare, Koninklijke Philips N.V., ... about 48% in the global market in 2015. Strong ... two key factors assessed to be aiding these players ... Research states that the players in the global market ...
(Date:2/23/2017)... February 23, 2017 Tillotts Pharma ... Berlin office was opened in ... . The portfolio includes Entocort ® for the ... treatment of ulcerative colitis, and VistaPrep ® for ... Swiss specialty pharmaceutical company focused on the treatment of ...
(Date:2/23/2017)... VANCOUVER, British Columbia , Feb. 23, ... ) today announced its year end 2016 financial results.  ... January 2017, OncoGenex, and Achieve Life Science, Inc., a privately ... into a definitive merger agreement under which OncoGenex will ... the proposed merger, Achieve,s stockholders are expected to own ...
Breaking Medicine Technology: