Diabetic Macular Edema News and Research

RSS

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.

Molecular Partners completes MP0112 phase I/IIa trials in wet AMD, DME

Molecular Partners AG, a leader in the development of next generation therapeutics, announced today that it has completed two phase I/IIa clinical trials with MP0112, its lead molecule targeting VEGF-A.

28 Apr 2011

Positive results from Sanofi-aventis and Regeneron ZALTRAP Phase III study in mCRC

Sanofi-aventis and Regeneron Pharmaceuticals, Inc. announced that the Phase III VELOUR trial evaluating the investigational agent ZALTRAP, also known as VEGF Trap, in combination with the FOLFIRI chemotherapy regimen versus a regimen of FOLFIRI plus placebo met its primary endpoint of improving overall survival in the second-line treatment of metastatic colorectal cancer.

27 Apr 2011

FDA accepts Regeneron's VEGF Trap-Eye BLA for review

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has accepted for review the Company's Biologics License Application for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration.

18 Apr 2011

Bayer, Regeneron initiate two VEGF Trap-Eye Phase 3 trials in Diabetic Macular Edema

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that they have initiated the first of two Phase 3 clinical trials evaluating the efficacy and safety of VEGF Trap-Eye, an investigational new agent for the treatment of certain eye diseases, in the treatment of Diabetic Macular Edema.

8 Apr 2011

ActiveSite's ASP-440 plasma kallikrein inhibitor effective in reducing diabetes-induced blood-retinal barrier breakdown

ActiveSite Pharmaceuticals, Inc., announced today the online publication of a study in the journal Diabetes that describes the effectiveness of its novel plasma kallikrein inhibitor ASP-440 in reducing blood-retinal barrier breakdown in a rodent model of diabetes.

28 Mar 2011

Genentech's Lucentis Phase III trials in DME meets primary endpoints

Genentech, a member of the Roche Group, announced today that the second of two Phase III trials evaluating Lucentis in patients with diabetic macular edema met its primary endpoint.

28 Mar 2011

SARcode's SAR 1118 Phase 2 data against dry eye to be presented at ARVO meeting

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.

25 Mar 2011

Quark Pharmaceuticals receives results from Phase 2 trial of PF-04523655 in patients with DME

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.

19 Mar 2011

Genentech announces positive outcomes from Lucentis Phase III trial against DME

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.

11 Mar 2011

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

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.

22 Feb 2011

Phase III RISE study of Lucentis for DME meets primary endpoint

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.

14 Feb 2011

Diabetes Management – a new journal addressing the management issues of a complex disease

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.

6 Feb 2011

Alimera reports 36-month results from ILUVIEN Phase 3 FAME study for DME

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.

4 Feb 2011

Positive top-line results from ILUVIEN Phase 3 trial in patients with DME

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.

4 Feb 2011

Regeneron, Bayer and SERI initiate new VEGF Trap-Eye Phase 3 clinical trial in myopic CNV

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.

18 Jan 2011

Alimera receives FDA CRL for ILUVIEN NDA

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.

24 Dec 2010

Positive top-line results from VEGF Trap-Eye Phase 3 studies in macular edema due to CRVO

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).

20 Dec 2010

Phase 3 study of VEGF Trap-Eye regimen meets primary endpoint in patients with wet AMD

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.

22 Nov 2010

pSivida awarded $489,000 grant under IRS Qualifying Therapeutic Discovery Project

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.

4 Nov 2010

Alimera Sciences obtains $32.5M senior secured credit facility

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.

15 Oct 2010