Ophthalmology Organizations Provide Checklist for Reopening ASC

To facilitate the reopening of ophthalmological ambulatory surgery centers (ASC) that had to close, due to the COVID-19 pandemic, the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, and the Outpatient Ophthalmic Surgery Society jointly released the “Ophthalmic ASC Reopening Checklist.”

Specifically, the checklist is comprised of sections on Administration, Clinical/Infection Prevention, Life Safety checks, Sterilization, and Pharmacy. The Clinical/Infection checklist, for example, asks:

• Has the ASC set protocols for screening for COVID-19 in patients prior to surgery?
• Has the ASC made arrangements for social distancing in the lobby or allowed responsible adults to wait in cars?
• Has the ASC made arrangements to greet patients or have signage posted to instruct patients not to enter if they have a fever or are experiencing symptoms of respiratory infection?
• Has the ASC informed patients and family members they must wear a mask or facial covering based on city, county, and state health authorities’ recommendations?
• If visitors are allowed in the lobby, has the ASC ensured that there are social distancing measures in place (chair separation or roped off)? Is the lobby free of any items, such as magazines? Has the ASC addressed cleaning services throughout the day for the lobby area?
• Has the ASC ensured that cleaning services and employees will continually wipe down high-touch areas (door handles, keyboards, counter tops, etc.) with an FDA-approved registered disinfectant?

For the full checklist, visit https://bit.ly/3c5e6do .

Study Focuses on Ocular Findings in COVID-19 Patients

Preliminary data from a study of 38 viral conjunctivitis patients with COVID-19 suggest the disease may be transmitted via the eye.

Researchers examined ocular manifestations and viral prevalence in patients who had an average age of 65.8 years and were treated from February 9 - February 15, 2020, at a hospital in Hubei province, China.

Results showed that 12 individuals had ocular manifestations, such as epiphora, conjunctival congestion, or chemosis, and these commonly occurred in patients with more severe systemic manifestations and are consistent with conjunctivitis or pink eye. None had blurred vision.

The researchers also found that, “By univariate analysis, patients with ocular symptoms were more likely to have higher white blood cell and neutrophil counts and higher levels of procalcitonin, C-reactive protein, and lactate dehydrogenase than patients without ocular symptoms.” More significant changes in blood test values occurred in patients with ocular abnormalities.

The researchers said they hope the data will help ophthalmologists and others to understand the ocular manifestations of COVID-19, which could improve diagnosis and prevent disease transmission.

The study was published online on March 31 by JAMA Ophthalmology.

Drug Shows Promise for Dry Eye Symptoms

Kala Pharmaceuticals, Inc. has announced positive results of the Short Term Relief In Dry Eye (STRIDE) 3, a Phase 3 clinical trial of 901 patients that evaluated the safety and efficacy of KPI-121 0.25%, a nanoparticle ophthalmic suspension of loteprednol etabonate for treating the signs and symptoms of dry eye disease.

Specifically, KPI-121 0.25% met both pre-specified primary and key secondary endpoints, demonstrating statistically significant improvement in ocular discomfort and conjunctival hyperemia at day 15 compared with vehicle. Significant results were also observed for total corneal staining at day 15. KPI-121 0.25% was well tolerated, with the most reported adverse event instillation site pain (2.9%). The incidence of IOP increase was low and similar between KPI-121 and vehicle arms.

Additionally, the company has announced that the FDA has accepted for review the company’s New Drug Application (NDA) resubmission for KPI-121, which will be called Eysuvis. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its review of the NDA.

Kala Pharmaceuticals said it is preparing for a potential U.S. approval and launch by the end of 2020.

Bressler Prize Awarded for Corneal Work

Netherlands physician, Gerrit Melles, MD, PhD, was awarded the Lighthouse Guild’s 2020 Bressler Prize In Vision Science for his advances in corneal transplantation.

With a clinical focus on managing corneal disorders and researching and developing new ophthalmic surgical procedures, Dr. Melles, the founder and director of several organizations specializing in ocular surgery, such as the Netherlands Institute for Innovative Ocular Surgery, has invented several advanced lamellar keratoplasty techniques, including Descemet membrane endothelial keratoplasty and Bowman’s layer transplantation.

The Prize, named for Alfred Bressler, a New York attorney interested in vision impairment who supported The Lighthouse Guild, has, since 2003, annually recognized a mid-career vision clinician or scientist who has made advances in the understanding of vision loss, treatment of eye disease, or the rehabilitation of those with vision loss. The Prize comes with an unrestricted cash award of $54,000, which is given in conjunction with a scientific symposium.

Cornea Guttata Patients Who Undergo Phacoemulsification at High Risk For Transplant

The relative risk of corneal transplantation in cornea guttata patients post-phacoemulsification was close to 70 times higher than for patients without the condition, reports April’s Journal of Cataract & Refractive Surgery. That said, most of the cornea guttata patients did not have a corneal transplant during the study period.

The findings came from 276,362 cataract patients linked with data from 2,091 patients who had a corneal transplant. The incidence rate of the surgery post-phacoemulsification in cornea guttata patients was 88/10,000 person years. Additionally, the annual incidence rate in the first year was highest, though lessened thereafter, and the incidence rate of corneal transplantation in patients without cornea guttata was 1.4/10,000 person years.

Correction: April Issue

In the April issue’s article “Dry Eye Treatments: Pharmaceutical vs Procedural,” cyclosporine ophthalmic solution 0.09% formulated with nanomicelle technology was incorrenctly referred to as “Promacta, Novartis.” It should have read “Cequa, Sun Ophthalmics.” The editor appologizes for this oversight. CP