The FDA approved the addition of safety information about the risk for retinal vasculitis and/or retinal vascular occlusion in patients receiving the drug. News Alerts
Tag: News Alert
More Medical Conferences Fall to Coronavirus
Several more meetings join the list of those that have canceled or postponed. Medscape Medical News
FDA OKs First Biodegradable Implant to Lower IOP
Bimatoprost implant (Durysta) delivers 10 µg of the prostaglandin analog and is an alternative to daily topical eye drops in patients with open-angle glaucoma or ocular hypertension. FDA Approvals
FDA OKs First Generic of Daraprim (Pyrimethamine) Tablets
Generic pyrimethamine, from Cerovene Inc, is indicated for the treatment of toxoplasmosis when used with a sulfonamide. FDA Approvals
FDA Approves First Treatment for Thyroid Eye Disease
The monoclonal antibody teprotumumab reduces proptosis and related eye problems in patients with thyroid-associated ophthalmopathy. FDA Approvals
FDA OKs Ophthalmic Stain for Vitreoretinal Surgery
Brilliant Blue G (0.025%) ophthalmic solution selectively stains the internal limiting membrane to distinguish it from the retina to facilitate removal. FDA Approvals
Brolucizumab Gets EU Panel Backing for Wet AMD
The treatment, previously approved by the FDA, offers less-frequent injections, and efficacy proven in two head-to-head global trials. International Approvals
FDA OKs First Contact Lens to Slow Myopia in Children
MiSight (CooperVision Inc) soft, disposable contact lenses are meant to be worn daily (but not overnight) to correct nearsightedness and slow the progression of myopia in children 8 to 12 years old. FDA Approvals
FDA Approves New Injection Brolucizumab (Beovu ) for Wet AMD
The US Food and Drug Administration approved brolucizumab (Beovu, Novartis) injection for wet age-related macular degeneration (AMD). FDA Approvals
EMA Panel Backs Netarsudil for Elevated Intraocular Pressure
An EMA advisory panel recommended marketing authorization for netarsudil ophthalmic solution 0.02% for the treatment of adults with glaucoma or ocular hypertension. International Approvals
US News Releases Latest Top Hospitals List
Mayo Clinic is still number 1, and for the 4th straight year, MD Anderson CC is tops in cancer, Cleveland Clinic is tops in cardiology, and the Hospital for Special Surgery is number 1 in orthopedics. Medscape Medical News
FDA Clears First Zika Blood Test for Routine Use
The ZIKV Detect 2.0 IgM Capture ELISA had previously been authorized only for emergency use under the FDA’s emergency use authorization authority. FDA Approvals
FDA OKs Aflibercept (Eylea) for Diabetic Retinopathy
The VEGF inhibitor is already approved for neovascular (wet) age-related macular degeneration, macular edema after central retinal vein occlusion, and diabetic macular edema. FDA Approvals
FDA OKs Rocklatan, a New Once-Daily Eye Drop for Glaucoma
The netarsudil and latanoprost ophthalmic solution (Rocklatan) reduces elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. FDA Approvals
FDA Issues Class I Recall of Raindrop Near Vision Inlay Device
The recall stems from a postapproval study showing an increased risk for corneal haze associated with the device. News Alerts
FDA Approves Lotemax SM For Ocular Surgery Pain, Inflammation
The FDA has approved a new formulation of loteprednol etabonate ophthalmic gel (Lotemax SM, Bausch + Lomb) 0.38% for postoperative inflammation and pain following ocular surgery. FDA Approvals
EU Panel Recommends Humira Biosimilars Idacio, Kromeya
The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization for two biosimilars that are highly similar to Humira (adalimumab, AbbVie). International Approvals
FDA Clears Novel Eye Tracking Test to Detect Concussion
EyeBOX is the first noninvasive, baseline-free test to help in the diagnosis of concussion. The 4-minute test is appropriate for ages 5 to 67 years. FDA Approvals
FDA OKs Steroid Insert (Dextenza) for Postop Ocular Pain
Dextenza is the first FDA-approved intracanalicular insert that delivers dexamethasone to treat ocular pain following ophthalmic surgery for up to 30 days with a single insertion. FDA Approvals
EC OKs Gene Therapy Luxturna for Inherited Retinal Dystrophy
International Approvals