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.
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diseases, today announced that the United Kingdom's National Institute for Health and Care Excellence issued draft guidance recommending ILUVIEN for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema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.
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.
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.
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.
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.
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.
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.
Regeneron Pharmaceuticals, Inc. today announced financial and operating results for the fourth quarter and full year 2012 and provided an update on development programs.
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.
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.
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).
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.
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.
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).
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.
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.
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.
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).
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.
Ampio Pharmaceuticals, Inc. (AMPE), a clinical stage biopharmaceutical company, with repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction announced today that it has entered into a definitive agreement with Ethypharm Ltd for the manufacturing of Zertane, Ampio's drug for the treatment of premature ejaculation.
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