Alimera Sciences fails to get FDA approval for Iluvien. Iluvien is a sustained release drug delivery system that releases a steroid into the eye for the treatment of diabetic macular edema. Alimera received the denial late last week in a letter from the FDA. Implant Too Risky In short, the FDA still has concerns about the safety of the new drug. Original concerns about cataract … [Read more...]
Two Lasers for Diabetic Retinopathy
June 22, 2011 By 5 Comments
There are two different laser treatments to treat diabetic retinopathy. One laser treatment is used to treat diabetic macular edema, the most common "complication" of diabetic retinopathy. The second laser treatment is used to treat proliferative diabetic retinopathy (aka PDR), yet far fewer people develop this potentially blinding stage of the disease. Same Laser Used for Both … [Read more...]
Alimera Sciences Says Iluvien Effective at 3 Years
May 18, 2011 By 10 Comments
Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval. The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year. The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new drug … [Read more...]
Laser and anti-VEGF Best Treats Diabetic Macular Edema
April 27, 2011 By 4 Comments
Treating diabetic retinopathy with both laser and anti-VEGF injections may be the best way to treat patients with diabetic macular edema. Diabetic macular edema is the most common "side effect" of diabetic retinopathy and is the leading cause of vision loss in patients with diabetes. The results of a large, multicenter, randomized clinical trial compared several permutations of laser and the … [Read more...]
VEGF-Trap Gets Closer to FDA Approval
April 20, 2011 By 1 Comment
VEGF-Trap (aka aflibercept), another anti-VEGF drug, moves closer to FDA approval as it received "priority review" status. This status means that the FDA process will be accelerated and the drug can be reviewed in 6 months versus the usual 10 month period. Alfibercept is another injectable drug that may have an effect on choroidal neovascularization in wet macular degeneration. In the press … [Read more...]
Diabetic Macular Edema: Have No Fear
March 1, 2011 By 12 Comments
Diabetic macular edema (DME) is swelling in the retina caused by diabetic retinopathy. More specifically, the swelling is located in the macula, the functional center of the retina. Diabetic Macular Edema Occurs In Almost Everyone DME is the most common "side effect" or complication of diabetic retinopathy. It should not be feared, but rather, it should be … [Read more...]
FDA Denies Iluvien
January 10, 2011 By Leave a Comment
The Food and Drug administration fails to approve Iluvien for the treatment of diabetic retinopathy and cites the need for more safety information in addition to concerns about the safety of the manufacturing process of Iluvien. Alimera Sciences had hoped to gain approval by the end of December 2010, instead, it was told by the FDA that more information was needed. Safety and Efficacy of … [Read more...]
VEGF Trap-Eye Treats Macular Degeneration
November 23, 2010 By 3 Comments
VEGF Trap-Eye (aflibercept) is another treatment for wet macular degeneration. The sponsoring pharmaceutical companies, Bayer and Regeneron, just reported favorable results in their own Phase III studies. Basically these studies compared aflibercept against well known Lucentis (ranibizumab). They report that VEGF Trap is just as good as Lucentis. Funny Name, But Still an Injection Despite … [Read more...]
Retina Specialists Have Classes All Their Own
October 26, 2010 By 1 Comment
Preceeding the AAO, retina specialists have a 2 day meeting of their own. It's a time for me to take classes or instructional courses on subjects related to my sub-specialty of retinal disease. Other sub-specialists (cornea, pediatic ophthalmology, glaucoma) do the same. Our meeting is focused on all things retina...naturally. Not much new information was presented during the sub specialty … [Read more...]
