Macular Edema News and Research

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European Commission approves EYLEA for treatment of visual impairment due to macular edema following CRVO

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA® (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO).

29 Aug 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pSivida reports that NICE issues draft guidance for use of ILUVIEN for pseudophakic patients with DME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diseases, today announced that the United Kingdom's National Institute for Health and Care Excellence issued draft guidance recommending ILUVIEN for the treatment of pseudophakic patients (those who have undergone prior cataract surgery) with chronic diabetic macular edema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

InSite Vision starts patient enrollment in confirmatory Phase 3 clinical trial of BromSite

InSite Vision Incorporated today announced that patient enrollment has begun in the confirmatory Phase 3 clinical trial of BromSite (ISV-303) for the reduction of inflammation and pain after cataract surgery.

10 May 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

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