Macular Edema News and Research

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Bayer Yakuhin seeks marketing authorization in Japan for EYLEA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that Bayer Yakuhin, Ltd., Osaka, Japan, has submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan for marketing authorization for EYLEA, also known as VEGF Trap-Eye, for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

29 Jun 2011

PDL revises revenue guidance for second quarter 2011 to $122M

PDL BioPharma, Inc. (PDL) today revised its guidance for the second quarter ending June 30, 2011, to approximately $122 million, as compared with actual results of $120 million for the second quarter of 2010, an anticipated one percent year-over-year increase.

9 Jun 2011

Bayer HealthCare seeks EU marketing authorization of VEGF Trap-Eye for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

7 Jun 2011

pSivida resubmits ILUVIEN NDA to FDA for diabetic macular edema treatment

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that its licensee, Alimera Sciences, Inc., resubmitted a New Drug Application for the investigational drug ILUVIEN for the treatment of diabetic macular edema (DME) to the U.S. Food and Drug Administration (FDA) on May 12, 2011 to address questions raised in the Complete Response Letter (CRL) Alimera received in December 2010.

16 May 2011

Study demonstrates value of MicroPulse technology for diabetic macular edema treatment

IRIDEX Corporation today announced that leading clinicians have performed and published the results of a new study that compares the benefits of MicroPulse photocoagulation technology, similar to that used in the new generation IRIDEX lasers, over the standard-of-care protocol for the treatment of eyes with diabetic macular edema.

5 May 2011

pSivida presents data of ILUVIEN Phase 3 trial in Diabetic Macular Edema at ARVO 2011

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the presentation of new data from the completed 36-month FAME Study of ILUVIEN for the treatment of Diabetic Macular Edema at the 2011 ARVO Annual Meeting.

4 May 2011

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

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

NIH: Diabetic retinopathy leads to vision loss in working-age Americans

Diabetes is often called the "silent killer" because people who have it are often unaware they are affected. According to the American Diabetes Association, diabetes affects 26 million people – including children – in the United States. Approximately one-quarter of those people do not know they're living with the disease.

23 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

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

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

Ifa Systems acquires inoveon

ifa Systems AG, the global leader for IT solutions in ophthalmology based in Cologne, Germany, announced the acquisition of inoveon Corporation, proven experts in detection, staging, and monitoring of diabetic retinopathy and macular edema.

10 Jan 2011

Insite Vision announces completion of patient enrollment in ISV-303 Phase 1/2 trial for post surgical ocular pain, inflammation

InSite Vision Incorporated, a company developing novel ophthalmic therapeutics, today announced that patient enrollment was recently completed in the company's Phase 1/2 clinical trial of ISV-303, a novel compound being developed to reduce the pain and inflammation associated with ocular surgery.

6 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