Diabetic Macular Edema News and Research

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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.

Lucentis receives Health Canada approval for treatment of retinal vein occlusion

Following a priority review, Health Canada has approved Lucentis (ranibizumab) as a treatment for vision loss resulting from retinal vein occlusion (RVO). This makes Lucentis the first approved treatment of its class in Canada for this debilitating condition. Patients will now have access to a treatment that is proven to be effective and has an established safety profile.

18 Aug 2011

HSS, pSivida enter orthopedic evaluation agreement

Drug delivery company pSivida Corp. today announced it has entered into an evaluation agreement with Hospital for Special Surgery (HSS), a world leader in orthopedics, rheumatology and rehabilitation, to investigate pSivida's drug delivery technologies in orthopedics.

17 Aug 2011

Sofinnova Ventures leads $44 million Series B private equity financing for SARcode Bioscience

SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced today the completion of a $44 million Series B private equity financing. The financing round was led by Sofinnova Ventures and was augmented by the additional backing of Rho Ventures and existing investors Alta Partners and Clarus Venture Partners.

18 Jul 2011

Positive results from sarilumab Phase 2b trial on RA, ankylosing spondylitis

Sanofi and Regeneron Pharmaceuticals, Inc. announced results from Phase 2b trials in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) with sarilumab, a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor.

13 Jul 2011

Positive results from RISE and RIDE Phase III trials of Genentech's Lucentis for diabetic macular edema

Genentech, a member of the Roche Group, today announced 24-month results from the two pivotal Phase III trials (RISE and RIDE) assessing the efficacy and safety of Lucentis (ranibizumab injection) in people with diabetic macular edema (DME).

29 Jun 2011

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

NASDAQ halts Regeneron's common stock

Regeneron Pharmaceuticals, Inc. announced that NASDAQ has halted trading of the company's common stock.

17 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

Ampio's common stock to be listed on NASDAQ Capital Market

Ampio Pharmaceuticals, Inc., a clinical stage developer of new uses for previously approved drugs and new molecular entities, announces that its common stock has been approved for listing on the NASDAQ Capital Market.

18 May 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

SARcode reports encouraging data from SAR 1118 Phase 2 dry eye trial

SARcode Corporation presented data today for their lead investigational molecule, SAR 1118. In a Phase 2 dry eye trial, subjects receiving SAR 1118 demonstrated a reduction in corneal staining, increased tear production, and improved visual-related function as compared to placebo. These data were part of the scientific program of the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held in Fort Lauderdale, Florida.

4 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

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.