Eyecare

At issue is an ongoing review of inspection results from a third-party filling company. No issues were cited in the FDA’s complete response letter about clinical efficacy or safety.

Overall, Descemet membrane endothelial keratoplasty cost less than Descemet stripping automated endothelial keratoplasty and can be done faster, according to findings reported by University of Michigan researchers.

Results reported in JAMA Ophthalmology show that about 20% of those with diabetic retinopathy have a case that could threaten their vision.

The Dry Eye Foundation reported 205 eye drops to the FDA that were not found in the FDA database.

Regulators indicated there was a lack of evidence of effectiveness and lack of clinical trials done to support the application.

The FDA has approved two novel therapies for patients with dry eye disease: Vevye (previously CyclASol) is a water-free, preservative-free solution, and Miebo, which address the excessive tear evaporation that is seen with dry eye.

Vevye (previously CyclASol) is a water-free, preservative-free solution, which allows for improved bioavailability and better efficacy on the target tissue.

Exposure to second-hand smoke may be more harmful for young children than adults because of their faster respiratory rate.

Researchers using data from prospective cohort studies identify higher levels of diglycerides and triglycerides in the blood as possibly playing an important role in the multifactorial causation of glaucoma.

Findings reported in JAMA Opthalmology show substantial decrease from 30 years ago.

Study shows the risk after COVID-19 vaccination is comparable to risk after flu and Tdap vaccine, and that the risk from COVID-19 infection is much greater.

The surface of the eye is exposed to airflow from inhaling and exhaling air. A snug fit can reduce if not eliminate the problem.

American Indian and Alaska Native had increased access to diabetes treatment services, which lowered hyperglycemia and blood lipid levels, as well as diabetic retinopathy incidence.

The discovery of a protein that determines levels of vascular endothelial growth factor-A (VEGF) could lead to new therapies for macular degeneration, diabetic retinopathy and other common causes of vision loss.

Iheezo, approved in September 2022, is an ocular surface anesthesia used during cataract surgeries.

If approved, ADX-2191 could be the first marketed drug specifically for patients with primary vitreoretinal lymphoma. The FDA assigned a Prescription Drug User Fee Act date of June 21, 2023.

Disparities in access to pediatric eye care have increased over the past 15 years and are associated with lower socioeconomic status.

CSF-1 is a low-dose pilocarpine to treat patients with age-related blurry vision. The FDA has assigned a PDUFA goal date of Oct. 22, 2023

Starting with Avastin to treat patients with diabetic macular edema — and switching to Eylea if patients don’t have a response — could result in savings of more than $125 million.

Apellis’ Syfovre will have a list price of $2,190 per vial, and Medicare is expected to be the dominant payer.

Sedentary behavior has been linked with low-grade systemic inflammation, which could disrupt the ocular surface.

Avacincaptad pegol has the potential to slow the progression of geographic atrophy in age-related macular degeneration. The PDUFA goal date is Aug. 19, 2023.

Eylea now also treats retinopathy of prematurity, a leading cause of childhood blindness worldwide.

If approved, reproxalap would be the first inhibitor of RASP to treat patients with dry eye disease. The FDA PDUFA date is Nov. 23, 2023.

Scientists have created a lipid nanoparticle that was able to deliver mRNA to the retina, providing an opportunity for the development of additional gene therapies for the eye.

Researchers found that visual impairment is more prevalent among those who are older, Hispanic, non-White, and less educated and have lower incomes.

Girls were more likely to develop dry eye after surgery, and nondominant eyes are more likely to develop postoperative dry eye.

If approved, CSF-1 would be the second therapy to treat patients with presbyopia, or age-related blurry vision.

Iyuzeh is a preservative-free formulation of latanoprost and doesn’t need to be stored at refrigerated temperatures. It will be available in the second half of 2023.