Macular Edema News and Research

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JDRF, KalVista collaborate to focus on novel approach for diabetic macular edema

KalVista Pharmaceuticals and JDRF have formed a research partnership focused on a novel approach being developed by KalVista to preserve vision and slow the progression of diabetic eye disease.

9 Jan 2012

Clearside Biomedical receives $4M venture capital investment

Technology developed by researchers at the Georgia Institute of Technology and Emory University for delivering drugs and other therapeutics to specific locations in the eye provides the foundation for a startup company that has received a $4 million venture capital investment.

6 Jan 2012

IRIDEX announces data from MicroPulse laser therapy study on DME

IRIDEX Corporation today announced that data from a clinical study compiled over 10 years demonstrates the safety and efficacy of MicroPulse laser therapy for treating diabetic macular edema (DME) without the retina tissue damage associated with conventional laser therapy.

12 Dec 2011

Akebia commences dosing in AKB-9778 Phase 1 study for diabetic macular edema and retinopathy

Akebia Therapeutics, Inc., a small molecule discovery and development company focused on anemia and vascular disorders, today announced that it has dosed the first subjects in a first-in-man Phase 1 study of AKB-9778, a first-in-class human protein tyrosine phosphatase beta (HPTPβ) inhibitor in development for diabetic macular edema (DME) and diabetic retinopathy (DR).

21 Nov 2011

Mesoblast cleared to begin first phase 2 clinical trial for wet AMD

Regenerative medicine company Mesoblast Limited (ASX: MSB) today announced that it has received regulatory clearance from the Singapore Health Sciences Authority (HSA) to commence the first Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult stem cell therapy for patients with proliferation of leaky blood vessels in the eyes – neovascular (“wet”) Age-related Macular Degeneration (AMD).

24 Oct 2011

Mesoblast receives Singapore HSA regulatory clearance to begin wet AMD Phase 2 trial

Regenerative medicine company Mesoblast Limited today announced that it has received regulatory clearance from the Singapore Health Sciences Authority (HSA) to commence the first Phase 2 trial of its proprietary allogeneic (off-the-shelf) adult stem cell therapy for patients with proliferation of leaky blood vessels in the eyes – neovascular Age-related Macular Degeneration.

24 Oct 2011

JDRF, iCo Therapeutics collaborate for iCo-007 Phase 2 trial in DME

iCo Therapeutics Inc. today announced that the company has entered into a research collaboration agreement with JDRF, the worldwide leader for research to cure, treat, and prevent type 1 diabetes (T1D), to support the previously announced Phase 2 investigator sponsored clinical trial investigating iCo-007 in Diabetic Macular Edema.

26 Sep 2011

Lucentis receives Health Canada approval to treat vision loss from DME

Health Canada has approved Lucentis (ranibizumab) as a treatment for vision loss resulting from diabetic macular edema, one of the major causes of adult vision loss and an important complication of the growing epidemic of diabetes.

14 Sep 2011

KalVista raises £8 million in series A round of funding

KalVista Pharmaceuticals, a new ophthalmology company with a focus on diabetic macular edema (DME), has raised £8 million in a series A round from leading life sciences investors Novo A/S and SV Life Sciences.

23 Aug 2011

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

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

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