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Alimera Sciences' Medidur(TM) Trial Exceeds 500 Patient Mark In Phase 3 Trial Enrollment
Alimera Sciences, a privately held
ophthalmic pharmaceutical company, and global drug delivery company pSivida
Limited (Nasdaq: PSDV, ASX: PSD, Xetra: PSI) today announced that
enrollment for their Phase 3 global clinical trial, the FAME(TM)
(Fluocinolone Acetonide in Diabetic Macular Edema) Study has exceeded 50
percent. FAME is a double masked, randomized, multi-center study that will
follow approximately 900 patients in the U.S., Canada, Europe and India for
36 months. The trial is studying the safety and efficacy of the novel
treatment currently referred to as Medidur for diabetic macular edema
(DME).
Medidur, a tiny, injectable intravitreal insert, is 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). Using a proprietary 25 gauge transconjunctival injector
system, an eye care professional injects the Medidur insert into the
vitreous through a minimally invasive procedure in an outpatient setting.
"Reaching this milestone in the FAME trial is a significant
accomplishment for Alimera as we continue our efforts to bring this next
generation of retinal drug delivery to market," said Dan Myers, CEO of
Alimera Sciences.
"pSivida is delighted with the progress being made in this trial and we
expect successful completion of enrollment later this year," said Dr. Paul
Ashton, Managing Director of pSivida Limited.
Alimera Sciences and pSivida Limited announced in February 2005 a
worldwide agreement to co-develop and market the insert for the use of
fluocinolone acetonide to treat DME. The agreement also includes the option
to identify, prior to February 2008, three other compounds not previously
licensed by pSivida to a third party for use in Medidur for ophthalmic
diseases. This option has the potential to result in a license to three
additional products with the Medidur insert for Alimera. Pfizer also
recently reached an agreement with pSivida to commit up to US$155 million
for development related to different ophthalmic applications of the Medidur
technology.
"As our work continues, we are pleased with recent announcements
underscoring the development interest and commitments by companies like
Pfizer for this technology," said Myers. "It reinforces the confidence that
we have in the technology as well."
Diabetic retinopathy (DR), a complication of diabetes mellitus, is the
leading cause of blindness in the working-age population of developed
countries. At any time during progression of diabetic retinopathy, patients
can develop DME which involves retinal thickening of the macular area.
There are currently more than 500,000 people with DME in the United States
and this number is expected to exceed 700,000 by the year 2010;
approximately 75,000 new cases of DME are diagnosed each year.
About Alimera Sciences Inc.
Alimera Sciences Inc., a venture backed company, specializes in the
development and commercialization of over-the-counter and 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
patient's lives and to strengthen physicians' ability to manage ocular
conditions. For more information, please visit
http://www.alimerasciences.com.
About pSivida Limited
pSivida is a global bio-nanotech company committed to the biomedical
sector and the development of drug delivery products. Retisert(R) is FDA
approved for the treatment of uveitis. Vitrasert(R) is FDA approved for the
treatment of AIDS-related CMV Retinitis. Bausch & Lomb own the trademarks
Vitrasert(R) and Retisert(R). pSivida has licensed the technologies
underlying both of these products to Bausch & Lomb. The technology
underlying Medidur(TM) for diabetic macular edema is licensed to Alimera
Sciences and is in Phase III clinical trials.
pSivida owns the rights to develop and commercialize a modified form of
silicon (porosified or nano-structured silicon) known as BioSilicon(TM),
which has applications in drug delivery, wound healing, orthopedics, and
tissue engineering. The most advanced BioSilicon(TM) product, BrachySil(TM)
delivers a therapeutic, P32 directly to solid tumors and is presently in
Phase II clinical trials for the treatment of pancreatic cancer.
This document contains forward-looking statements that involve risks
and uncertainties including with respect to the efficacy of pSivida's drug
delivery technology and the final results of the clinical trials described
above. Although we believe that the expectations reflected in such
forward-looking statements are reasonable at this time, we can give no
assurance that such expectations will prove to be correct. Given these
uncertainties, readers are cautioned not to place undue reliance on such
forward-looking statements. Actual results could differ materially from
those anticipated in these forward-looking statements due to many important
factors including those contained in cautionary statements in the Annual
Report on Form 20-F filed with the U.S. Securities and Exchange Commission,
including, without limitation, under Item 3.D, "Risk Factors" therein. We
do not undertake to update any oral or written forward-looking statements
that may be made by or on behalf of pSivida.
Alimera Sciences
http://www.alimerasciences.com
View drug information on Vitrasert Implant.
Alimera ªtiinþe "Medidur (tm) proces depãºeºte 500 de pacienþi marca de fazã 3 în proces de înscriere - Alimera Sciences' Medidur(TM) Trial Exceeds 500 Patient Mark In Phase 3 Trial Enrollment - articole medicale engleza - startsanatate