The new device, which can replace reading glasses, addresses the prevalence of presbyopia and an aging boomer population, the FDA says. FDA Approvals
Tag: News Alert
FDA Approves Photrexa for Corneal Crosslinking in Keratoconus
The riboflavin ophthalmic solution, once irradiated with ultraviolet A light, treats sight-threatening keratoconus with corneal collagen crosslinking. FDA Approvals
FDA Proposes Ban of Powdered Medical Gloves
A ban of powdered gloves for surgery and patient exams would not create a glove shortage, given the ascendancy of powderless alternatives, the agency said. News Alerts
Zika in Early Pregnancy May Be More Dire, CDC Suggests
The CDC found more fetal brain abnormalties than it expected. Perhaps not surprisingly, the agency cautioned pregnant women today not to attend the summer Olympics in Brazil, epicenter of the Zika outbreak. Medscape Medical News
FDA Issues Guidance to Protect Blood Supply From Zika Virus
The FDA recommendations are more expansive than safeguards announced earlier this month by the American Red Cross. Medscape Medical News
Arkansas Compounding Pharmacy Recalls Sterile Products
US Compounding was flagged in two recent FDA inspections for apparent safety lapses such as poor cleaning and disinfection. The vast majority of recalled products are injectables. News Alerts
Allergan Recalls Contaminated Eye Ointments
Customers reported discovering a black particle that caused superficial eye injury, pain, swelling, and blurred vision. News Alerts
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