Macular Edema News and Research

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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

Ampio Pharmaceuticals starts Optina clinical trial

Ampio Pharmaceuticals, Inc. announced oral dosing of the first patient in a 505(b)(2) clinical trial of the investigational drug Optina in diabetic macular edema.

27 Feb 2013

Sucampo's RESCULA 0.15% now available by prescription across the U.S.

Sucampo Pharmaceuticals, Inc. today announced that RESCULA (unoprostone isopropyl ophthalmic solution) 0.15% is now available by prescription across the United States. The U.S. Food and Drug Administration (FDA) approved a sNDA for RESCULA for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension on December 7, 2012.

19 Feb 2013

Regeneron fourth quarter total revenues increase to $415 million

Regeneron Pharmaceuticals, Inc. today announced financial and operating results for the fourth quarter and full year 2012 and provided an update on development programs.

14 Feb 2013

FDA approves Takeda’s NESINA, OSENI and KAZANO for treatment of type 2 diabetes

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NESINA (alogliptin) and the fixed-dose combination (FDC) therapies OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl) for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

28 Jan 2013

FDA approves Ampio’s IND for Optina for treatment of diabetic macular edema

Ampio Pharmaceuticals, Inc. announced today that the FDA has accepted the Company's IND for Optina™ for the treatment of diabetic macular edema (DME). Ampio plans to commence enrollment in a clinical trial in the first quarter of 2013. The FDA granted Optina™ 505(b)(2) status in July, 2012. Drugs designated under this pathway can be approved on a single trial.

22 Jan 2013

Spain approves pSivida’s ILUVIEN to treat chronic diabetic macular edema

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, announced today that the Spanish Agency of Drugs and Medical Devices (Agencia Espanola de Medicamentos y Productos Sanitarios) granted marketing authorization to ILUVIEN for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

18 Jan 2013

Fingolimod associated with modest, rapid increase in macular volume

Patients with multiple sclerosis treated with fingolimod undergo a modest but rapid increase in macular volume, research shows.

13 Dec 2012

Bayer submits MAA in Europe for EYLEA to treat macular edema after CRVO

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare today announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for EYLEA (aflibercept) Injection for the treatment of macular edema following Central Retinal Vein Occlusion (CRVO).

6 Dec 2012

NICE reject intravitreal implant for diabetic macular edema

The UK National Institute for Health and Clinical Excellence has not recommended a fluocinolone acetonide intravitreal implant for individuals with diabetic macular edema who do not respond to existing therapies.

5 Dec 2012

U.K. NICE issues final draft guidance on Alimera Sciences’ ILUVIEN

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the United Kingdom's National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance indicating that ILUVIEN is not recommended for the treatment of chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.

30 Nov 2012

EC approves Regeneron’s EYLEA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD).

27 Nov 2012

ThromboGenics receives FDA approval for Jetrea to treat symptomatic vitreomacular adhesion

On Oct. 17, the U.S. Food and Drug Administration approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).

19 Oct 2012

Quick, cheap eye scan can predict brain damage in people with multiple sclerosis

An inexpensive, five-minute eye scan can accurately assess the amount of brain damage in people with the debilitating autoimmune disorder multiple sclerosis (MS), and offer clues about how quickly the disease is progressing, according to results of two Johns Hopkins studies.

19 Oct 2012

Ranibizumab improves driving prospects for AMD patients

Treatment with ranibizumab can preserve and even improve the perceived driving ability of patients with age-related macular degeneration, show the results of two randomized trials.

10 Oct 2012

Ranibizumab injections keep those with AMD driving longer

The advanced neovascular, or “wet,” form of age-related macular degeneration (AMD), left untreated, is the most common cause of vision loss among the elderly and a leading reason for their loss of driving privileges. But results of a new study, published in the online version of the journal Ophthalmology, suggest that monthly injections of ranibizumab improve eye chart test results required for a driver’s license, build driver confidence and keep those with AMD driving longer.

3 Oct 2012

pSivida reports revenues of $699,000 for fourth quarter 2012

pSivida Corp., a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced financial results for its fourth quarter and fiscal year ended June 30, 2012.

25 Sep 2012

Aerpio Therapeutics commences AKB-9778 Phase 1b/2a trial in diabetic macular edema

Aerpio Therapeutics, a clinical-stage biopharmaceutical company developing innovative therapies for vascular diseases by targeting the Tie2 pathway, today announced that it has dosed the first patient in a Phase 1b/2a trial of AKB-9778 for the treatment of diabetic macular edema (DME).

20 Sep 2012

Age at diabetes onset linked to macular edema onset

Older age at onset of Type 1 diabetes significantly increases the risk for developing clinically significant macular edema, show study findings.

19 Sep 2012

Factors predictive of successful DME treatment revealed

The pretreatment central subfield thickness in the eyes of patients with diabetic macular edema is the strongest predictor of outcome after one year of treatment with ranibizumab, with a reduction linked to better visual acuity outcomes, report researchers.

14 Sep 2012