The IDx-DR device detects greater than mild diabetic retinopathy without the need for a clinician to interpret the image or results. FDA Approvals
Tag: News Alert
FDA OKs First Transitional Contacts That Darken in Sunlight
Acuvue Oasys Contact Lenses With Transitions Light Intelligent Technology are the first contact lenses to incorporate the technology used in eyeglasses that automatically darken in the sun. FDA Approvals
FDA OKs Dexycua Intraocular Suspension for Cataract Surgery
Dexycu, which is administered as a single injection immediately after surgery, eliminates the need for patients to use eyedrops following cataract surgery. FDA Approvals
Trump’s Doctor Says Health Excellent, Attributes ‘Good Genes’
Along with his overall health the president had a perfect score on the MoCA test, showing excellent cognitive health, said the White House physician. Medscape Medical News
FDA Approves Novel Gene Therapy for Rare Form of Vision Loss
Luxturna is for children and adults with a form of inherited vision loss that may lead to blindness. It is the first gene therapy approved in the United States to treat a disease caused by mutations in a specific gene. FDA Approvals
CHMP Backs Once-Weekly GLP-1 Analog Semaglutide
The nod from the European Medicines Agency’s advisory panel follows approval by the US Food and Drug Administration. International Approvals
FDA: Blindness Risk From Compounded Vancomycin Eye Injections
The FDA is warning against intraocular injections of vancomycin either alone or in combination with other drugs, in light of a new case of hemorrhagic occlusive retinal vasculitis. News Alerts
FDA Warns About Triamcinolone and Moxifloxacin Combo for Eye
The FDA issued a safety alert after serious adverse events were reported in at least 43 patients who received a compounded triamcinolone and moxifloxacin product by intravitreal injection. News Alerts
EMA Backs Verkazia Eyedrops for Vernal Keratoconjunctivitis
Vernal keratoconjunctivitis, also known as spring catarrh, is a rare form of chronic eye allergy seen mostly in young children and teenagers. International Approvals
Georgia Public Health Chief Brenda Fitzgerald, MD, to Head CDC
Widely respected in public health circles and politically connected, Dr Fitzgerald is perhaps best known for an initiative to encourage language development in babies. News Alerts
FDA Clears Cetirizine Eye Drops for Allergic Conjunctivitis
Cetirizine ophthalmic solution 0.24% (Zerviate) is the first topical ocular formulation of the antihistamine for treatment of ocular itching associated with allergic conjunctivitis. FDA Approvals
FDA Approves Tocilizumab (Actemra) for Giant Cell Arteritis
The FDA has expanded the approved use of subcutaneous tocilizumab (Actemra, Hoffman LaRoche) to include treatment of adults with giant cell arteritis. FDA Approvals
CHMP Backs Cenegermin (Oxervate) for Neurotrophic Keratitis
The CHMP has recommended granting marketing authorization for Oxervate for the treatment of adults with moderate or severe neurotrophic keratitis. International Approvals
FDA: Fluoroquinolones Not Linked to Retinal Detachment
Available evidence does not support reports that fluoroquinolone antibiotics may result in retinal detachment or aortic aneurysm or dissection, the FDA said. News Alerts
FDA OKs Ranibizumab for All Forms of Diabetic Retinopathy
The VEFG inhibitor had been approved just for diabetic retinopathy accompanied by diabetic macular edema, in addition to other eye disorders. FDA Approvals
FDA Clears New Corrective Intraocular Lens From Alcon
The AcrySof IQ ReSTOR +3.0D Multifocal Toric IOL corrects presbyopia and pre-existing corneal astigmatism at the time of cataract surgery in adults. FDA Approvals
FDA Clears Ranibizumab for Myopic Choroidal Neovascularization
Ranibizumab becomes the first FDA-approved anti-vascular endothelial growth factor therapy for mCNV. FDA Approvals
False Positives Common With LabCorp Zika Testing, FDA Warns
The ZIKV Detect test for virus antibodies always requires confirmation. A higher-than-expected rate of false positives underlines the need for double-checking. News Alerts
It’s Final: FDA Bans Powdered Gloves in Surgery, Medicine
The move follows efforts already underway to switch to safer alternative gloves for surgical use and in patient examinations. News Alerts
Texas Reports Local Zika Case, First Outside Florida
The Texas health department believes that a woman became infected from the bite of a local mosquito. Medscape Medical News