EW Weekly, March 27, 2020

Study: Risk of COVID-19 ocular transmission is low
A review of 64 tear samples collected from 17 COVID-19 patients in Singapore suggested a low risk of ocular transmission, according to Ivan Seah, MBBS, and coresearchers, in a study published in Ophthalmology. The study collected samples at days 3 to 20 from initial symptoms. The virus was not detected by viral culture or reverse transcription polymerase chain reaction. Further studies are needed, including research on the association between serum viral load and viral shedding in tears and research to prove the presence of angiotensin-converting enzyme 2 (ACE2) in corneal and conjunctival cells, the researchers concluded. SARS-CoV-2 has been shown to infect cells via ACE2 receptors, they wrote.

Physician payment terms extended for EYLEA injections due to COVID-19
Because of the COVID-19 pandemic, physician payment terms will be temporarily extended for EYLEA (aflibercept, Regeneron Pharmaceuticals) injection purchases made from authorized distributors to 150 days, according to a news release. Physicians may be eligible for the 150-day payment terms versus the previous 100 days. Ophthalmologists should verify the timing and dating terms for their offices with their authorized distributors. Regeneron plans to implement the new temporary terms by April 1 and have them apply retroactively for an EYLEA vial or prefilled syringe purchased on or after March 1. The company is working with the American Academy of Ophthalmology (AAO) during the current COVID-19 pandemic to support ophthalmologists, according to the AAO news release. More information is available at regeneron.com/covid19.

Emergency authorization given for molecular COVID-19 diagnostic assay
Quidel received Emergency Use Authorization from the U.S. FDA to market its Lyra SARS-CoV-2 assay, a real-time reverse transcription polymerase chain reaction test, according to a company announcement. The test is geared for qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or oropharyngeal swab specimens from patients. The test is currently available only for sale in the U.S. Quidel also makes ophthalmic-geared tests for dry eye disease and acute conjunctivitis.

Production expanded for genetic test kits for new coronavirus detection
Avellino is adding production shifts for its new Avellino SARS-CoV-2/COVID-19 test, the company reported in a press release. The test can help clinicians diagnose COVID-19 by identifying and isolating genetic markers as approved by the Centers for Disease Control and Prevention and the FDA. To meet the growing demand for the test, Avellino is temporarily suspending sequencing operations for its AvaGen genetic test, used to find individuals at risk for keratoconus and the presence of corneal dystrophies.

Aldeyra to begin screening RASP inhibitors for potential activity to treat COVID-19
Aldeyra Therapeutics will begin to screen its library of reactive aldehyde species (RASP) inhibitors, including ADX-629 and reproxalap, for potential anti-inflammatory and anti-viral activity to treat COVID-19, according to a company news release. ADX-629 is a member of the same chemical class as reproxalap, a RASP inhibitor currently part of Phase 3 clinical testing for ocular inflammation. “ADX-629 and reproxalap are structurally related to chloroquine and hydroxychloroquine, drugs currently in clinical testing for the treatment of COVID-19 infection,” according to the company. Both have been shown to lower inflammation in animal models. A Phase 1 single- and ascending-dose clinical trial has been completed with ADX-629, and a Phase 2 trial is planned for later this year in patients with immune-mediated disease. Additionally, in response to a recent U.S. Department of Health and Human Services solicitation, the company has submitted a proposal to the Biomedical Advanced Research and Development Authority for the development of ADX-629 for the treatment of COVID-19. Healthcare industry partners who may be interested in testing ADX-629 pursuant to the U.S. FDA’s Emergency Use Authorization guidelines can get in touch with the company. Aldeyra has a variety of products under development for ocular disease.

Pivotal trial for dry AMD/GA treatment Zimura delayed due to COVID-19
Initiation of the enrollment of patients in a second pivotal clinical trial for avacincaptad pegol (Zimura, IVERIC bio) for geographic atrophy secondary to dry age-related macular degeneration (AMD) has been delayed due to the new coronavirus pandemic, according to a company announcement. When it does begin, the company will enroll an estimated 400 patients in its international, multicenter, double-masked, sham-controlled trial. Patients will be randomized for monthly administration of Zimura 2 mg or sham during the first year of the trial. If the results are positive, the company will file an application with the FDA and the European Medicines Agency for marketing approval of the drug. The company will re-randomize patients in the Zimura 2 mg arm at month 12 to receive monthly or bimonthly administration of the drug.

COVID-19: News You Can Use
ASCRS is publishing a series called COVID-19: News You Can Use, a repository of information including links, tips, and resources to help navigate the fluid COVID-19 landscape. The e-newsletter will be published as new information relevant to its members emerges.

Research Briefs
  • Between 2012 and 2019, private equity-backed acquisitions of ophthalmology and optometry practices grew rapidly, and some platform companies have already been sold or recapitalized to new investors, reported Evan Chen, BS, and coresearchers in their cross-sectional study of private acquisition and investment data. A total of 228 private equity acquisitions in the U.S. were researched using acquisition and financial investment data from six financial databases, four industry news outlets, and publicly available press releases. Among the 228 practices were 1,466 clinical locations and 2,146 ophthalmologists or optometrists acquired by 29 private equity-backed platform companies. The acquisition rate grew rapidly during the study time period, with 42 practices acquired between 2012 and 2016 and 186 from 2017 to 2019. Three platform companies were sold or recapitalized, with a median holding period of 3.5 years. The acquisitions took place in 40 states, with most private equity firms developing multistate platform companies. The study appears in Ophthalmology.
  • Use of a custom silicone artificial iris implantation was moderately risky but effective at lowering light and glare sensitivity and improving ocular cosmesis, reported Clémence Bonnet, MD, and coresearchers. Their prospective, consecutive case series included a review of medical records of 19 patients implanted with the artificial iris and followed for a year. Corrected distance visual acuity (CDVA), IOP, endothelial cell count, surgical complications, secondary interventions, and adverse events were among the safety measures analyzed. The CDVA with glare, subjective day and night glare, and subjective cosmetic appearance were among the efficacy measures. Among the 20 included eyes, the CDVA improved in 13 and got worse in six. The endothelial cell count decreased from 1,918 cells/mm2 to 1,405 cells/mm2. The eight eyes with postop complications included IOP elevations (four eyes), corneal decompensations (two eyes), cystoid macular edema (one eye), and device dislocation (one eye). Four eyes had secondary surgical interventions, including two adverse events (one glaucoma surgery and one device dislocation). The CDVA with glare improved from 1.5 to 0.7 logMAR (P<0.01), and the mean daytime glare lowered from 8.9 to 2.7. Night glare decreased from 7.9 to 2.5. Mean cosmesis improved from 2.2 to 8.8 (P<0.01). The research is published in the Journal of Cataract & Refractive Surgery.

Product News
  • Heidelberg Engineering reintroduced its HRT3 Rostock Cornea Module to the global market to offer in vivo corneal confocal microscopy.
  • Topcon Healthcare is offering all of its slit lamp customers a free breath shield to fit onto their instrument in light of the COVID-19 pandemic. Customers must register online to receive it. It is available while supplies last.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), is published every Friday, distributed by email, and posted live on Friday.

Medical Editors: Eric Donnenfeld, MD, Chief Medical Editor; Rosa Braga-Mele, MD, Cataract Editor; Clara Chan, MD, Cornea Editor; Nathan Radcliffe, MD, Glaucoma Editor; and Vance Thompson, MD, Refractive Editor

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