The FDA has granted Ampio Pharmaceuticals approval for its oral drug Optina to address diabetic macular edema. The drug obtained 505-b-2 status last year, making it eligible for approval based on a single study.
Genentech's Lucentis, or ranibizumab injection, has been approved by the FDA as a treatment for myopic choroidal neovascularization. The drug has previously been approved to treat macular edema after retinal vein occlusion, wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy in people with DME.
In two Phase III trials, Bayer's VEGF Trap-Eye drug, also called Eylea, met its primary endpoint in treating diabetic macular edema, the company said. The firm co-develops the medication with Regeneron, which plans to seek U.S. marketing approval this year for the treatment of diabetic macular edema.
Ampio Pharmaceuticals obtained FDA approval to initiate a clinical trial of Ampion, a non-steroidal anti-inflammatory biologic drug, in patients with knee osteoarthritis. Ampio is eligible to submit a biologics license application once the trial ends.
FDA regulators on Thursday recommended 0.3-milligram and 0.5-milligram doses of Roche Holding's Lucentis drug for patients with diabetic macular edema. "The committee's recommendation is an important step towards improving the care of Americans with diabetic macular edema. If approved by the FDA, this will be the first major development for treating diabetic macular edema in more than 25 years," stated Genentech, a Roche Holdings unit.