The FDA approved an extension of dosing intervals for Eylea HD in patients with diabetic macular edema and wet age-related macular degeneration, Regeneron Pharmaceuticals, Inc. announced.
The approval, which extended the dosing intervals up to every 20 weeks, also includes an update to the Eylea HD (aflibercept 8 mg, Regeneron) label to include 2-year data from “the pivotal” PULSAR and PHOTON trials, according to a press release.
“The potential for needing only two or three Eylea HD injections a year to manage certain retinal diseases is an exciting advance that could benefit

The CDC issued a health advisory to warn health care professionals, laboratorians, veterinarians and people at risk for overdose about rising reports of medetomidine in the U.S. illicit drug supply.
The agency also warned of severe withdrawal syndrome due to medetomidine exposure.
According to the advisory, medetomidine — also known as “rhino tranq,” “dex” or “mede” — is approved for analgesia and sedation in dogs but not for use in people.
The CDC said that the sedative — first identified in the illegal drug supply in 2021 — has been

Editor’s note: This is a developing news story. Please check back soon for updates.
K.C. Pharmaceuticals is recalling more than 3.1 million bottles of eye drops due to “lack of assurance of sterility,” according to the FDA.
The eight affected products, totaling 3,111,072 individual units, have been distributed throughout the U.S.
It is a class II recall, meaning the drops may cause temporary or reversible adverse effects, or have a low probability of causing severe adverse effects.
The following products have been recalled:

Zenkuda demonstrated superiority over sham in patients with diabetic retinopathy in the phase 3 GLOW2 study, according to a press release from Kodiak Sciences.
In the confirmatory study, patients with proliferative diabetic retinopathy and mild diabetic macular edema and patients with moderately severe to severe diabetic retinopathy were randomly assigned to receive Zenkuda (tarcocimab tedromer) intravitreal injection (130 patients) or sham injection (125 patients), with dosing at baseline and at weeks 4, 8, 20 and 44. By the end of the study, all patients were on a 6-month dosing interval.
At

Using six gut- and diet-derived metabolites, a machine learning model had 79% accuracy in classifying adults as having cognitive impairment or being cognitively healthy, according to data published in Gut Microbes.
“Blood-based markers may soon help identify patients at elevated risk long before cognitive impairment can be detected by imaging or clinical tests,” David Vauzour, PhD, HDR, AFHEA, MRSC, associate professor in molecular nutrition at the University of East Anglia’s Norwich Medical School in the U.K., told Healio. “These markers could support early stratification, helping clinicians

COVID-19 vaccination during pregnancy protected infants up to 6 months after birth, according to a study published recently in Pediatrics.
The study is part of a larger research project in Scandinavia investigating COVID-19 in pregnancy, according to lead author Helena Niemi Eide, MD, MPH, a doctoral research fellow in the department of community medicine and global health at the University of Oslo in Norway.
“When new vaccines are introduced, it is important to study the consequences for pregnant women and their children, including both safety and effectiveness,” Eide told Healio. “This study