Ranibizumab News and Research

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ForSight VISION4 to receive first milestone payment for Lucentis drug delivery device

Genentech, a member of the Roche Group, today announced it will make its first milestone payment to ForSight VISION4, Inc. as part of an exclusive license agreement to develop the company's investigational drug delivery device, designed to provide sustained delivery of Lucentis (ranibizumab).

13 Jan 2012

FDA approves EYLEA for treatment of wet Age-related Macular Degeneration

Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has approved EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD) at a recommended dose of 2 milligrams every four weeks for the first 12 weeks, followed by 2 mg every eight weeks.

19 Nov 2011

Regeneron receives FDA approval for Eylea to treat wet AMD

The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

18 Nov 2011

Macular degeneration drug may cause increased IOP

Two major drug trials conclude there was little risk from a drug aimed at age-related macular degeneration. Yet a Mayo Clinic ophthalmologist began to note something concerning in some of her patients: an increase in pressure inside the eye. It led to a retrospective study and findings that will be presented at the American Academy of Ophthalmology in Orlando.

24 Oct 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

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

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

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

Avastin, Lucentis are equally effective for age-related macular degeneration treatment

Age-related macular degeneration, a disease that damages the retina and can destroy central vision, affects approximately 1.6 million Americans. For the past five years, there has been active debate over treatment options for AMD patients because ophthalmologists have not had accurate data regarding the true efficacy of the most commonly used medication.

29 Apr 2011

Genentech's Lucentis Phase III trials in DME meets primary endpoints

Genentech, a member of the Roche Group, announced today that the second of two Phase III trials evaluating Lucentis in patients with diabetic macular edema met its primary endpoint.

28 Mar 2011

Genentech announces positive outcomes from Lucentis Phase III trial against DME

Genentech, a member of the Roche Group, today announced that two-year results from a pivotal Phase III trial showed patients with diabetic macular edema who received Lucentis experienced rapid and sustained improvement in vision compared to those who received a placebo injection.

11 Mar 2011

Regeneron submits VEGF Trap-Eye BLA to FDA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Under the Prescription Drug User Fee Act (PDUFA), the goal for a standard review time from submission to FDA action is ten months.

22 Feb 2011

Phase III RISE study of Lucentis for DME meets primary endpoint

Genentech, Inc., a member of the Roche Group, announced today that one of two Phase III studies evaluating monthly Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME), met its primary endpoint. DME is a serious complication of diabetes that affects up to 10 percent of people with the disease and can lead to blurred vision, severe vision loss and blindness.

14 Feb 2011

Regeneron, Bayer and SERI initiate new VEGF Trap-Eye Phase 3 clinical trial in myopic CNV

Regeneron and Bayer HealthCare announced initiation of a new Phase 3 clinical trial in collaboration with the Singapore Eye Research Institute investigating the efficacy and safety of VEGF Trap-Eye (aflibercept ophthalmic solution) in patients with choroidal neovascularisation (CNV) of the retina as a result of pathologic myopia.

18 Jan 2011

Positive top-line results from VEGF Trap-Eye Phase 3 studies in macular edema due to CRVO

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced positive top-line results for VEGF Trap-Eye (aflibercept ophthalmic solution) in the COPERNICUS study, which is led by Regeneron, the first of two Phase 3 studies in patients with macular edema due to central retinal vein occlusion (CRVO).

20 Dec 2010

Phase 3 study of VEGF Trap-Eye regimen meets primary endpoint in patients with wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that in two parallel Phase 3 studies in patients with the neovascular form of age-related macular degeneration (wet AMD), all regimens of VEGF Trap-Eye (aflibercept ophthalmic solution), including VEGF Trap-Eye dosed every two months, successfully met the primary endpoint compared to the current standard of care, ranibizumab dosed every month.

22 Nov 2010

Positive results from XOMA 052 study in patients with uveitis of Behcet's disease

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, announced additional positive results from an open-label pilot study of XOMA 052 in patients with uveitis of Behcet's disease who were suffering from vision-threatening exacerbations despite maximal doses of immunosuppressive medicines.

10 Nov 2010

XOMA receives final $2.0 million from Kaketsuken under antibody technology collaboration

XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, today announced receipt of the final $2.0 million payment from Kaketsuken under the $8.0 million collaboration announced in November 2009. The agreement involves multiple proprietary XOMA antibody research and development technologies, including a new XOMA phage display library, and a suite of integrated information and data management systems.

1 Nov 2010

2010 AAO-MEACO meeting focuses on genetic medicine

Genetic medicine is the focus of two presentations at today's Scientific Program of the 2010 American Academy of Ophthalmology (AAO) Middle East-Africa Council of Ophthalmology (MEACO) Joint Meeting. The AAO-MEACO meeting is in session October 16 through 19 at McCormick Place, Chicago. It is the largest, most comprehensive ophthalmic education conference in the world.

18 Oct 2010