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.

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

SARcode Bioscience initiates enrollment in SAR 1118 Phase 3 study for dry eye disease

SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced today that the initial patient has been enrolled in the company's pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution.

15 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

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.