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
Tag: News Alert
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
FDA Clears First Drug for Neurotrophic Keratitis
Cenegermin eye drops (Oxervate) are a recombinant form of human nerve growth factor that stimulate growth and survival of corneal epithelial cells. FDA Approvals
FDA Clears Hydrus Microstent for Glaucoma
The Hydrus microstent used in conjunction with cataract surgery achieves significant and sustained lowering of intraocular pressure in patients with primary open-angle glaucoma. FDA Approvals
FDA OKs First Artificial Iris for Aniridia, Other Iris Defects
The CustomFlex Artificial Iris treats adults and children with congenital aniridia or iris defects due to other reasons or conditions, such as albinism, traumatic injury, or surgical removal due to melanoma. FDA Approvals
FDA OKs AI Device to Detect Diabetic Retinopathy in Primary Care
The IDx-DR device detects greater than mild diabetic retinopathy without the need for a clinician to interpret the image or results. FDA Approvals
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