EW Weekly, August 7, 2020

- Enrollment complete for pivotal clinical trial of glaucoma shunt
- Orphan Drug Designation granted for treatment of RHO mutation-associated retinal degenerative disease
- Clinical trial design for investigational dry eye drug agreed upon
- Positive 1-year data from Phase 1/2a trial of gene therapy for wet AMD
- Topline data supports efficacy, safety of thyroid eye disease drug
- 2021 Medicare Physician Fee Schedule (MPFS) proposed rule released
- Research highlights
- Product News
- A quality improvement study was conducted in the Izmir Tepecik Training and Research Hospital in Turkey after the first case of COVID-19 was reported to evaluate the spread of SARS-CoV-2 despite enhanced safety and sanitation measures. The research published in JAMA Ophthalmology describes how asymptomatic patients were triaged into exam rooms and real-time PCR of samples from the biomicroscope, slit lamp breath shield, phoropter, tonometer, and door handles were taken before exams began and after the last patient left the room for the day. A total of 33 people visited the room. The mean exam time was 9 minutes. Two samples post-exam from the slit lamp breath shield and phoropter were positive for the virus. The study authors note that PCR doesn’t confirm infectivity of viral material, only presence.
- Stem cells (neural progenitor cells) were discovered in the optic nerve lamina region. These cells, according to the research published in the journal Proceedings of the National Academy of Sciences, are capable of generating all macroglial cell types for the anterior optic nerve. A press release about the research from the University of Maryland said that these cells could support repair and protection of the optic nerve fibers. The press release stated that this finding suggests a new theory for glaucoma development and could lead to new treatment therapies for age-related disorders causing vision loss.
- Two Phase 2 clinical trials that compared faricimab vs. ranibizumab—STAIRWAY and AVENUE—were published in JAMA Ophthalmology. The STAIRWAY 52-week trial included 76 nAMD patients receiving two different dosing regimens of faricimab every 16 or 12 weeks compared to monthly ranibizumab. At 24 weeks, 65% of faricimab patients had no disease activity, which suggests patients could go 16 weeks between treatments. Faricimab patients in both treatment arms gained 9.3 letters (12-week dosing) and 12.5 letters (16-week dosing) at week 40 (ranibizumab patients gained 11.4 letters). Further gains were seen at 52 weeks, with 10.1, 11.4, and 9.6 letters in the 12-week faricimab, 16-week faricimab, and monthly ranibizumab groups, respectively. More patients (46.4%) in the 16-week faricimab group gained 15 or more letters at 52 weeks compared to the ranibizumab group (37.5%). The 36-week AVENUE study of 273 nAMD patients that looked at four dosing regimens of faricimab compared to monthly ranibizumab found comparable outcomes in BCVA among all the groups. The authors of this study concluded that a Phase 3 trial is merited.
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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