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.

Bayer Yakuhin submits marketing authorization application in Japan for EYLEA Injection

Regeneron Pharmaceuticals, Inc. today announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd., has submitted an application for marketing authorization for EYLEA (aflibercept) Injection for the treatment of patients with diabetic macular edema (DME) to the Japanese Ministry of Health, Labour and Welfare.

3 Mar 2014

Regeneron receives FDA acceptance for EYLEA injection for treatment of macular edema

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review the Company's supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).

26 Feb 2014

Aerpio Therapeutics doses first patient in AKB-9778 Phase 2 trial for diabetic macular edema treatment

Aerpio Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on advancing innovative therapies for vascular diseases, today announced that it has dosed the first patient in a Phase 2 trial evaluating AKB-9778, a Tie2 activator, alone and in combination with ranibizumab (Lucentis) for the treatment of diabetic macular edema (DME). AKB-9778 is a first-in-class inhibitor of human protein tyrosine phosphatase beta (HPTPβ) that activates the Tie2 pathway to promote vascular stability, preventing abnormal blood vessel growth and vascular leak.

13 Feb 2014

SMC accepts ILUVIEN for use within NHS Scotland to treat vision impairment

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the Scottish Medicines Consortium (SMC) has accepted ILUVIEN for use within the National Health Service Scotland under a simple patient access scheme.

10 Feb 2014

pSivida announces financial results for second quarter 2014

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced financial results for its second quarter ended December 31, 2013.

10 Feb 2014

People with diabetes at risk of developing diabetic macular edema during their lifetime

Despite recent advances in prevention and treatment of most vision loss attributed to diabetes, a new study shows that fewer than half of Americans with damage to their eyes from diabetes are aware of the link between the disease and visual impairment, and only six in 10 had their eyes fully examined in the year leading up to the study.

20 Dec 2013

FDA accepts Regeneron's EYLEA Injection sBLA for standard review

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted for standard review the Company's supplemental Biologics License Application for EYLEA (aflibercept) Injection for the treatment of Diabetic Macular Edema.

18 Dec 2013

EYLEA Injection gets approval in Japan for treatment of macular edema following CRVO

Regeneron Pharmaceuticals, Inc. today announced that EYLEA (aflibercept) Injection has received approval for the treatment of Macular Edema Following Central Retinal Vein Occlusion from the Japanese Ministry of Health, Labour and Welfare.

22 Nov 2013

Allegro receives FDA IND approval to initiate Phase II clinical studies of ALG-1001 in AMD, VMT patients

Allegro Ophthalmics, LLC, a company dedicated to establishing Integrin Peptide Therapy as the next-generation pharmaceutical category for the treatment of vascular eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's Investigational New Drug (IND) application to begin two Phase II clinical studies of ALG-1001.

10 Oct 2013

New laser provides better treatment for eye diseases in diabetes patients

A new laser is helping experts at the Truhlsen Eye Institute at the University of Nebraska Medical Center provide better treatment for eye diseases. This advanced laser can prevent blindness for some patients with serious conditions.

24 Sep 2013

Thrombogenics, Bicycle Collaborate On Drugs Targeting Eye Diseases

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5 Sep 2013

ThromboGenics, Bicycle to develop and commercialize novel drugs for ophthalmic diseases

ThromboGenics NV, a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, today announces that it has entered into a collaboration and license agreement with Bicycle Therapeutics to develop and commercialize novel drugs inhibiting a specific target for the treatment of ophthalmic diseases, such as diabetic macular edema.

5 Sep 2013

Regeneron, Bayer report positive results from Phase 3 VIVID-DME and VISTA-DME trials of EYLEA for DME

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that in the Phase 3 VIVID-DME and VISTA-DME trials of EYLEA (aflibercept) Injection for the treatment of diabetic macular edema, EYLEA 2 milligrams (mg) dosed monthly and EYLEA 2 mg dosed every two months (after 5 initial monthly injections) achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity from baseline compared to laser photocoagulation at 52 weeks.

6 Aug 2013

Ico Therapeutics completes Phase 2 iDEAL study for treatment of diabetic macular edema

iCo Therapeutics Inc. announced today that it has completed enrollment of its Phase 2 iDEAL study evaluating the efficacy and safety after repeated injections of iCo-007 in patients with Diabetic Macular Edema (DME). The study has shown a good safety profile with no drug-related serious adverse events to date.

19 Jun 2013

pSivida reports that NICE issues draft guidance for use of ILUVIEN for pseudophakic patients with DME

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced that the United Kingdom's National Institute for Health and Care Excellence issued draft guidance recommending ILUVIEN for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema considered insufficiently responsive to available therapies.

15 Jun 2013

NICE Appraisal Committee reconfirms clinical effectiveness of ILUVIEN

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Appraisal Committee of the United Kingdom's National Institute for Health and Care Excellence has issued a positive Appraisal Consultation Document on ILUVIEN for the treatment of pseudophakic patients with chronic diabetic macular edema considered insufficiently responsive to available therapies.

14 Jun 2013

Alimera announces availability of ILUVIEN in U.K. for chronic DME treatment

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that ILUVIEN®, the first sustained release pharmaceutical product for the treatment of chronic diabetic macular edema, is now available in the United Kingdom.

29 Apr 2013

pSivida announces resubmission of ILUVIEN NDA to FDA for chronic diabetic macular edema

pSivida Corp., a specialty pharmaceutical company that is a leader in the development of sustained release ophthalmic drug treatments, today announced that its licensee Alimera Sciences, Inc. reported the submission of its response to the second Complete Response Letter from the U.S. Food and Drug Administration with respect to ILUVIEN for chronic diabetic macular edema.

2 Apr 2013

FDA accepts Ampio’s Patient Outcome for Premature Ejaculation questionnaire

Ampio Pharmaceuticals, Inc., a biopharmaceutical company developing drugs to treat prevalent inflammatory diseases, such as osteoarthritis (Ampion) and diabetic macular edema (Optina) and sexual dysfunction (Zertane) announced FDA acceptance of its POPE questionnaire, a modification of the Premature Ejaculation Profile (PEP) questionnaire that was used in the two successful Zertane Phase 3 clinical trials completed in Europe.

11 Mar 2013

Subclinical inflammation predicts macular disease

Levels of high-sensitivity C-reactive protein predict the risk for age-related macular degeneration and diabetic macular edema, show results of two independent studies published in JAMA Ophthalmology.

27 Feb 2013