- FDA approves nasal spray for dry eye
- Survey: 70% of adults don’t plan on receiving an eye exam this year
- Positive results in Phase 3 study for Acanthamoeba keratitis treatment
- Research on first-in-class therapy for retinal degenerative disease
- ASCRS news and events
October 22, 2021 • Volume 27, Number 42
FDA approves nasal spray for dry eye
Oyster Point Pharma announced FDA approval of its varenicline solution (TYRVAYA) as a nasal spray for treatment of signs and symptoms of dry eye disease. According to the company’s press release, TYRVAYA is the first and only nasal spray approved for this indication. It activates the trigeminal parasympathetic nerve pathway to increase production of basal tear film. The company’s press release noted the specific utility of a nasal spray for patients who have trouble administering drop therapies. The spray was studied in three clinical trials that included more than 1,000 patients with mild to severe dry eye disease with research showing that patients treated with the varenicline spray had statistically significant improvements in tear film production. The most common adverse reaction, which the company noted was reported in 82% of patients, was sneezing. TYRVAYA will be available for prescription in November, according to the company.
Survey: 70% of adults don’t plan on receiving an eye exam this year
Johnson & Johnson (J&J) Vision released findings from its annual J&J Vision Global Eye Health Survey of more than 16,000 adults in the U.S., U.K., China, France, Germany, Korea, Russia, and Brazil. It revealed that 70% of survey respondents don’t plan on getting an eye exam within the year, despite the survey revealing that 86% of respondents fear losing sight above any other sense and 88% saying they consider eye health maintenance a priority. Fifty-two percent of respondents reported receiving annual eye exams, according to J&J’s press release about the survey. Seventy-two percent of respondents who have had cataract surgery said they would have done it sooner if they’d known the positive impact it would have on their vision, with 56% also saying they didn’t realize how bad their vision was until after they had the procedure. Only 46% of respondents understood that cataract surgery is an outpatient procedure.
Positive results in Phase 3 study for Acanthamoebakeratitis treatment
SIFI announced positive topline results from its pivotal Phase 3 study of polihexanide 0.08% as a monotherapy for treatment of Acanthamoeba keratitis. Polihexanide met the primary endpoint of clinical resolution rate over a 12-month timeframe. From here, the company reported that it would request accelerated assessment of its product by the European Medicines Agency with intent to file a Marketing Authorization Application in the first half of 2022. If approved, polihexanide would become the first drug approved in Europe for treatment of Acanthamoeba keratitis.
Research on first-in-class therapy for retinal degenerative disease
Retrotope, a clinical-stage company, announced positive results from its preclinical studies of RT011, which it described as a novel technology platform being developed as an oral therapy for dry AMD. The research in an animal model showed dose-dependent protection of oxidative damage that is implicated in dry AMD development, according to the company’s press release. The company reported that these study results support its rationale to advance RT011 into a clinical program for dry AMD with an expectation to file an Investigational New Drug application in the first half of 2022 followed by the first-in-human clinical studies.
ASCRS news and events
- 20/Happy in 2021: The popular ASCRS Master Class in Refractive Cataract Surgery is back with a new CME module—20/Happy in 2021—hosted in person during the AAO Annual Meeting in New Orleans, Louisiana. If you’re attending the AAO Annual Meeting, join in the complimentary program Saturday, November 13, 5:00–9:00 p.m. CT at Hilton Riverside, St. Charles Ballroom.
- ASCRS Winter Symposium: Registration is open for the February 10–12, 2022, Winter Symposium in Park City, Utah. This meeting focuses on the innovative techniques and controversies in anterior segment ophthalmology and will honor Alan Crandall, MD (1947–2020), former co-chair of this meeting, former ASCRS president, and a tireless teacher and humanitarian.
- CME opportunity: “ASCRS Satellite CME: Supplemental Education to the ASCRS Annual Meeting” includes four, 1-hour programs captured from the 2021 Annual Meeting that are now available online and on-demand for viewing/claiming credit. Learn more.
- ASCRS Foundation: It’s National Sight Week! Visit the ASCRS Foundation’s website to see how volunteers are changing lives within their own communities by providing sight-restoring cataract surgery.
Research highlights
- A randomized clinical trial was designed to compare incidence of Descemet’s membrane detachment during phacoemulsification with two different corneal incision shapes. According to the study authors, the conventional 2.2-mm clear corneal incision is narrow in relation to the sleeve of the phaco handpiece and can result in incision site friction. The research compared the traditional 2.2-mm incision to a modified 2.2-mm incision that enlarged to an internal width of 3.0 mm, forming a trapezoid shape. The double-masked, parallel, randomized clinical trial of the two incision types was conducted at a single center in China from July 22, 2019–January 22, 2020. One hundred and thirty eyes with grade 4 or more hard cataracts and a corneal endothelial density of 1,500 cells/mm2 were included. The incidence of Descemet’s membrane detachment at postop day 1 was significantly lower in the group with the trapezoid-modified incision compared to that with the conventional incision at postop day 1, and the length of the detachment and maximal corneal thickness at the incision sight were lower in the modified group. There was no difference in BCVA, central corneal endothelium cell loss, or surgically induced astigmatism between the two groups. The research is published in JAMA Ophthalmology.
- Seasonal variations of IOP in normal tension glaucoma patients were investigated over a 20-year period. The retrospective cohort study used data from the Kyoto Prefectural University of Medicine Glaucoma Registry, which identified 1,774 normal tension glaucoma patients that were seen over the 20-year study period (January 1997–December 2016). Overall, the researchers observed a continuous decrease in IOP throughout the 20-year period with seasonal variation observed. The investigators created five groups for analysis of 4 consecutive years each (1997–2000, 2001–2004, 2005–2008, 2009–2012, and 2013–2016). They saw a continuous decrease in annual mean IOP in the groupings as they became more recent, with the oldest grouping having the highest annual mean IOP. Each group saw distinct seasonal variation of IOP, they reported. The study is published in the American Journal of Ophthalmology.
This issue of EyeWorld Weekly was edited by Stacy Jablonski and Liz Hillman.
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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