Fluid can leak into the center of the macula, the part of the eye where sharp, straight-ahead vision occurs. The fluid makes the macula swell, blurring vision. This condition is called macular edema. It can occur at any stage of diabetic retinopathy, although it is more likely to occur as the disease progresses. About half of the people with proliferative retinopathy also have macular edema.
SARcode Corporation announced today that clinical data for their lead compound, SAR 1118, has been accepted for presentation during the upcoming Association for Research in Vision and Ophthalmology Annual Meeting being held May 1–May 5, 2011, in Fort Lauderdale, Florida.
Quark Pharmaceuticals, Inc., a pharmaceutical company engaged in the discovery and development of RNAi-based therapeutics, today announced that it has received results from a prospective randomized Phase 2 trial, the DEGAS study.
Genentech, a member of the Roche Group, today announced that two-year results from a pivotal Phase III trial showed patients with diabetic macular edema who received Lucentis experienced rapid and sustained improvement in vision compared to those who received a placebo injection.
Regeneron Pharmaceuticals, Inc. announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review time from submission to FDA action is ten months.
Genentech, Inc., a member of the Roche Group, announced today that one of two Phase III studies evaluating monthly Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness.
Future Medicine Ltd has today announced the launch of Diabetes Management – a new bimonthly title presenting findings, analyses and commentaries on the battle with Type 1 and Type 2 diabetes. Diabetes Management is published by Future Medicine Ltd (UK, London) renowned for its collection of journals providing healthcare practitioners and research professionals with a unique source of objective, cutting-edge information on exciting trends emerging in light of advances in medicine, healthcare and clinical practice.
Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported results through month 36 of the completed FAME™ Study.
pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN for the treatment of Diabetic Macular Edema, today announced month 36, top-line readout results for the FAME Study prepared by its licensee, Alimera Sciences.
Regeneron and Bayer HealthCare announced initiation of a new Phase 3 clinical trial in collaboration with the Singapore Eye Research Institute investigating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia.
pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, including the investigational drug ILUVIEN® for the treatment of Diabetic Macular Edema (DME), today announced that Alimera Sciences, Inc, pSivida's collaborative partner, received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ILUVIEN. The FDA issued the CRL to communicate its decision that the NDA cannot be approved in its present form.
Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the COPERNICUS study, which is led by Regeneron, the first of two Phase 3 studies in patients with macular edema due to central retinal vein occlusion (CRVO).
Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that in two parallel Phase 3 studies in patients with the neovascular form of age-related macular degeneration (wet AMD), all regimens of VEGF Trap-Eye (aflibercept ophthalmic solution), including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month.
pSivida Corp., a leader in the development of sustained release drug delivery products for the treatment of back-of-the-eye disease including the product candidate Iluvien™ for the treatment of Diabetic Macular Edema, today announced that it has been awarded two grants totaling $489,000 under the IRS Qualifying Therapeutic Discovery Project (QTDP). The grants were awarded to pSivida to help fund further research on new generations of the company's drug delivery technologies targeting ophthalmic diseases.
Alimera Sciences, Inc. announced today that it has obtained a $32.5 million senior secured credit facility to help fund its working capital requirements. The credit facility consists of a $20 million revolving line of credit provided by Silicon Valley Bank and a $12.5 million term loan provided by MidCap Financial, LLC and Silicon Valley Bank.
Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that data from its Phase 3 (FAME) clinical trials for Iluvien will be presented this month at the annual meeting of the American Academy of Ophthalmology (AAO) in Chicago.
pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back of the eye diseases, including the product candidate Iluvien for the treatment of Diabetic Macular Edema, today announced financial results for its fourth quarter and fiscal year ended June 30, 2010.
pSivida Corp., a leader in the development of sustained release back of the eye drug delivery systems for difficult-to-treat conditions, today announced that its licensee, Alimera Sciences has been notified that the U.S. Food and Drug Administration (FDA) has granted Priority Review status for the New Drug Application (NDA) filed for Iluvien for the treatment diabetic macular edema (DME).
Alimera Sciences, Inc.,, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that the Company's New Drug Application (NDA) for Iluvien® (fluocinolone acetonide intravitreal insert) has been accepted for filing and granted Priority Review status by the U.S. Food and Drug Administration (FDA).
Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that it has granted Novartis an option to obtain an exclusive worldwide license to develop and commercialize its p53 temporary inhibitor siRNA drug QPI-1002, currently the subject of a Phase II clinical trial.
Alimera Sciences, Inc., today announced financial results for the second quarter ended June 30, 2010 and provided an update on progress toward achieving its 2010 goals.
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