Macular Edema News and Research

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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

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

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

Allergan third quarter diluted loss per share increases to $2.21

Allergan, Inc. today announced operating results for the quarter ended September 30, 2010. Allergan also announced that its Board of Directors has declared a third quarter dividend of $0.05 per share, payable on December 1, 2010 to stockholders of record on November 10, 2010.

1 Nov 2010

Alimera to present Iluvien Phase 3 clinical trial data at AAO annual meeting

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.

12 Oct 2010

FDA approves OZURDEX implant for uveitis treatment

Allergan, Inc. today announced that the United States Food and Drug Administration (FDA) has approved OZURDEX (dexamethasone intravitreal implant) 0.7 mg for the treatment of non-infectious ocular inflammation, or uveitis, affecting the posterior segment of the eye.

27 Sep 2010

pSivida reports $8.8 million consolidated net income for 2010 fiscal year

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.

23 Sep 2010

FDA approves Gilenya capsules for reducing MS relapses

The U.S. Food and Drug Administration has approved Gilenya capsules (fingolimod) to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis (MS).

22 Sep 2010

PDL BioPharma reports revenue guidance of $86 million for 2010 third quarter

PDL BioPharma, Inc. today announced revenue guidance for the third quarter ended September 30, 2010 of approximately $86 million, as compared with actual results of $71.4 million for the third quarter of 2009, a 20 percent year-over-year increase.

2 Sep 2010

pSivida announces FDA Priority Review status for Iluvien NDA

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).

31 Aug 2010

FDA grants Priority Review status to Alimera Sciences' Iluvien for diabetic macular edema

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).

31 Aug 2010