Customers reported discovering a black particle that caused superficial eye injury, pain, swelling, and blurred vision. News Alerts
Tag: News Alert
FDA Warns About Safety Risks for Ingenol Mebutate (Picato)
Reports of severe allergic reactions and herpes zoster with application of Picato gel for treatment of actinic keratosis have prompted an FDA safety warning and label change. News Alerts
CHMP Backs Three Drugs for Rare Diseases
The EMA committee backs treatments for lysosomal acid lipase deficiency, alpha1-proteinase inhibitor deficiency, and Leber’s hereditary optic neuropathy. International Approvals
Device That Helps Blind ‘See’ With Tongue Wins FDA Okay
In a demonstration of brain plasticity, video images are transformed into electrotactile signals on the tongue, allowing the blind to read letters, make out doorways, and recognize shapes in general. FDA Approvals
Dermal Fillers May Rarely Cause Serious Injury, FDA Warns
Unintentional injection of a dermal filler into blood vessels in the face may cause serious injury, the FDA warns; asks manufacturers to update labeling to indicate risk. News Alerts
FDA to Study Safety, Effectiveness of Healthcare Antiseptics
The agency urges clinicians to keep using the antiseptic products in question for the sake of infection control, even as it looks at the possible effects of daily, long-term use. News Alerts
FDA OKs First Near Vision Fix That Needs No Cataract Surgery
The first-of-its kind implant faced skepticism from an FDA panel that questioned its safety, but ultimately said the benefits outweighed the risks. FDA Approvals
FDA Clears New Vision-Correcting Intraocular Lens
The lens is for patients having cataract surgery who choose to correct their vision problems at the same time. FDA Approvals
Aflibercept (Eylea) Gets Expanded Indication in US
The FDA clears aflibercept for treatment of diabetic retinopathy in patients with diabetic macular edema. FDA Approvals
Europe Approves Western World’s First Stem-Cell Therapy for Rare Eye Condition
Europe has approved the Western world’s first medicine containing stem cells to treat a rare condition caused by burns to the eye, marking a milestone in the use of the technology. International Approvals
FDA Clears Ranibizumab for Diabetic Retinopathy With DME
Ranibizumab for diabetic retinopathy with DME had breakthrough therapy designation and was reviewed under the agency’s priority review program. FDA Approvals
Two Ophthalmic Drugs Receive Positive Nods in Europe
The European Committee for Medicinal Products has recommended approval of ciclosporin drops for severe keratitis and a new indication for aflibercept. International Approvals
First-Ever Stem Cell Therapy Recommended in EU
Stem cell treatment for a severe eye condition has been given special regulatory consideration, but marketing would be conditional. International Approvals
FDA OKs Aflibercept (Eylea) for All Retinal Vein Occlusions
The expanded indication now covers macular edema after branch retinal vein occlusion, and not just blockages to the central retinal vein. FDA Approvals
Eye Implant Iluvien for Diabetic Macular Edema Clears FDA
The FDA has approved eye implant Iluvien, from Alimera Sciences and pSivida Corp, for treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise…
FDA OKs Aflibercept (Eylea) for Diabetic Macular Edema
The drug is the first VEGF inhibitor that can be taken for less than once a month for this eye problem, the manufacturer has noted. FDA Approvals
Novartis Says Alcon Glaucoma Treatment Approved in EU
Novartis said the European Commission has approved its eyecare unit Alcon’s Simbrinza eye drops suspension to decrease elevated intraocular pressure (IOP) in adults with open-angle glaucoma or ocular hypertension. International Approvals
FDA OKs Ozurdex for Some With Diabetic Macular Edema
The new indication is for treatment of adults with diabetic macular edema who have an artificial lens implant (pseudophakic) or who are scheduled for cataract surgery (phakic). FDA Approvals
EU Panel OKs Aflibercept for Diabetic Macular Edema (Eylea)
The company marketing the drug in the United States has asked the US Food and Drug Administration to add this indication as well. International Approvals
FDA Approves Omidria for Cataract Surgery, Lens Replacement
The FDA has approved Omidria (phenylephrine and ketorolac injection) 1%/3% to maintain pupil size during cataract surgery or intraocular lens replacement and to reduce postoperative pain. FDA Approvals