- Study: Music reduces anxiety, hypertensive events in cataract surgery
- Phase 2 study results for investigational dry AMD treatment
- Phase 3 topline results for wet AMD therapeutic
- FDA accepts BLA for faricimab
- ASCRS news and events
August 6, 2021 • Volume 27, Number 31
Study: Music reduces anxiety, hypertensive events in cataract surgery
A randomized clinical trial of 309 patients undergoing cataract surgery for the first time evaluated the effect of music during surgery on anxiety and hypertensive events. All patients analyzed in the study were given local anesthesia for the surgery and were either assigned to listen to music via headphones or to wear noise-cancelling headphones (no music) for 20 minutes preop. The incidence of a hypertensive event was significantly lower in the music arm (13.6%) compared to the control arm (52.9%), according to the study published in JAMA Ophthalmology. Anxiety and sedative drug injections during surgery were also lower in the music arm vs. control.
Phase 2 study results for investigational dry AMD treatment
Allegro Ophthalmics announced publication of Phase 2a results for its investigational treatment for dry AMD. The study described risuteganib 1.0 mg for patients with intermediate dry AMD. Forty-eight percent of patients in the treatment group of the study achieved an 8 or more ETDRS BCVA gain from baseline at week 28 compared to 7% of controls at week 12. According to the company’s press release, there were no drug-related serious adverse events. The company described risuteganib as a small peptide oxidative stress stabilizer that protects RPE cells against oxidative stress-associated cellular dysfunction.
Phase 3 topline results for wet AMD therapeutic
Outlook Therapeutics announced positive topline results for ONS-5010/LYTENAVA (bevacizumab) for treatment of wet AMD. According to the company’s press release, the NORSE TWO Phase 3 clinical trial included 228 participants with wet AMD at 39 trial sites. Patients were randomized to receive ONS-5010 dosed monthly or Lucentis (ranibizumab, Genentech), which was dosed according to labeling instructions. Outlook Therapeutics reported both primary and secondary endpoints being met with statistical significance. The primary endpoint was gain of at least 15 letters in BCVA at 11 months, which was achieved by 41% of patients who were treated with ONS-5010 and 23% treated with Lucentis. The secondary endpoint was mean change in BCVA through month 11; mean change in BCVA in the ONS-5010 group was 11.2 letters and 5.8 letters in the Lucentis group.
FDA accepts BLA for faricimab
Genentech announced that the FDA accepted its submissions for a Biologics License Application (BLA) under priority review for faricimab, which the company described as a bispecific antibody that targets Ang-2 and VEGF-A. If approved in the future, faricimab could be used to treat wet AMD and/or diabetic retinopathy, the company’s press release stated.
ASCRS news and events
- ASCRS Clinical Survey: Fifteen minutes of your time can help inform the future of ASCRS educational initiatives and register you to win a prize. ASCRS members are eligible to take the ASCRS Clinical Survey.
- 2022 ASCRS Annual Meeting hotels: Discounted hotels for the 2022 ASCRS Annual Meeting in Washington, D.C., are filling up. Reserve your preferred hotel today.
- ASCRS Government Relations: Last week, ASCRS and AAO sent a letter to members of Congress asking for their support “to ensure patients have timely access to sight-restoring care by urging Aetna to rescind their problematic policy,” which since July 1 has required prior authorization for cataract surgery procedures. Learn more.
Research highlights
- Research published in the British Journal of Ophthalmology found a potential increase in myopia incidence in children related to the COVID-19 pandemic mitigation measures. The research included two separate longitudinal cohorts of children 6–8 years old in Hong Kong (a pre-COVID-19 cohort [n=1,084] and a COVID-19 cohort [n=709]). The overall incidence was 19.44% in the COVID-19 cohort and 36.57% in the pre-COVID-19 cohort. Spherical equivalent refraction change and axial length during the pandemic timeframe was –0.50±0.51 D and 0.29±0.35 mm, respectively. Time spent outdoors decreased from 1.27±1.12 to 0.41±0.90 hours/day, and screen time increased from 2.45±2.32 to 6.89±4.42 hours/day, according to the study.
- Analysis from the University of Michigan Kellogg Eye Center showed disparities in how patients accessed eyecare during the pandemic. The comparative study published in the American Journal of Ophthalmology included a stratified random sample of 1,720 patients seen by the eye center between April 30–May 25, 2020, with the odds of having a video, phone, or in-person visit compared to deferring a visit. The research found that older patients were less likely to have a video telemedicine visit and more likely to have an in-person visit vs. deferring a visit. In the non-retina sample, older patients were still less likely to have a video visit, according to the study. Non-white patients in the whole sample were less likely to have an in-person visit compared to being deferred (similar results were seen in the retina sample). The study authors concluded that despite older patients being at higher risk for severe effects of COVID-19, they were more likely to be seen for in-person care.
Product news
- Oertli Instrumente launched the CataRhex3 with SPEEP pump, a compact portable surgical platform for cataract and glaucoma surgery.
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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