The FDA has authorized use of the Valeda Light Delivery System (LumiThera), a multiwavelength photobiomodulation (PBM) device, to improve visual acuity in patients with dry age-related macular degeneration (AMD) who have best-corrected visual acuity (BCVA) of 20/32 to 20/70.
DRY AMD — About 90% of patients with AMD have the dry (non-neovascular) form, which is characterized by abnormalities of the retinal pigment epithelium with focal accumulation of metabolic byproducts known as drusen. Patients with dry AMD may experience a slow reduction in central vision. Geographic atrophy (GA) is an advanced...
RELEASE
The FDA has required a new warning in the labels of the recombinant respiratory syncytial virus (RSV) vaccines Arexvy (GSK) and Abrysvo (Pfizer) about an increased risk of Guillain-Barré syndrome (GBS) within 42 days of administration of either vaccine. Both vaccines are FDA-approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults. Abrysvo is also approved for use in pregnant women at 32-36 weeks’ gestation to prevent RSV-associated LRTD in their infants from birth through 6 months of age.1,2
GBS — According to the CDC, 3000-6000 cases of GBS are reported annually in the US; the syndrome is more common in men and in those >50 years old. In many cases, GBS occurs following a viral or bacterial infection. Administration of some COVID-19 and seasonal influenza vaccines has been associated with GBS.
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