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
Tag: News Alert
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
ER Doctor, Pharmacist Among Dead in Chicago Hospital Shooting
Doctors unite in mourning on Twitter and vent at the NRA, using #ThisIsOurLane. Medscape Medical News
Medicare Plans to Phase in Changes for Office-Visit Payments
CMS delays the start of a controversial E&M payment change but remains committed to collapsing what’s now a five-level coding system. Medscape Medical News
Newly Approved Toric ICL Implanted in First US Patient
A 37-year-old Illinois truck driver has become the first person in the United States to receive new implantable lenses for the correction of myopia with astigmatism approved by the US Food and Drug Administration last month. News Alerts
FDA Updates Advice on Withdrawn CyPass Glaucoma Stent
The FDA is now advising providers to periodically evaluate patients’ implanted stents for endothelial cell loss and determine if additional action is needed, including removal of the device. News Alerts
FDA Warns Against Using Raindrop Near Vision Inlay
The FDA today issued an alert about an increased risk for corneal haze in patients the device after 75% of patients in a postapproval study developed haze. News Alerts
FDA OKs Fluocinolone Intravitreal Implant (Yutiq) for Uveitis
In clinical trials, Yutiq significantly reduced recurrence rates at 6 and 12 months following treatment compared with sham treatment in patients with chronic, noninfectious posterior segment uveitis. FDA Approvals
PRAC Recommends Restrictions on Fluoroquinolone, Quinolones
The new restrictions follow a review of rare but disabling and potentially long-lasting side effects, mainly involving muscles, tendons, bones, and the nervous system. News Alerts
EU Panel Recommends Luxturna for Inherited Retinal Dystrophy
The EMA’s CHMP has recommended marketing authorization for voretigene neparvovec for inherited retinal dystrophy caused by RPE65 gene mutations in adults and children. International Approvals
FDA Clears New Form of Latanoprost (Xelpros) for Glaucoma
Xelpros is the first and only form of latanoprost that is not formulated with benzalkonium chloride, a preservative commonly used in topical ocular preparations. FDA Approvals
Alcon Pulls CyPass Glaucoma Micro-Stent Off the Global Market
The company cites 5-year safety data that show statistically significant endothelial cell loss in patients who received the CyPass stent at the time of glaucoma surgery. News Alerts
FDA OKs First Twice-Daily Steroid for Postsurgery Eye Pain
The nanoparticle formulation of loteprednol etabonate ophthalmic suspension (Inveltys, Kala Pharmaceuticals) is dosed two times daily rather than four times daily, with similar efficacy and safety. FDA Approvals