- FDA approves first prescription eye drop for presbyopia treatment
- Primary endpoint reached in Phase 2 trial for dry eye disease drug
- New type of retinal nerve cell discovered
- Companies enter collaboration to develop an oral DME, wet AMD treatment
- iCare USA acquires remote patient-monitoring tech company
- ASCRS news and events
November 5, 2021 • Volume 27, Number 44
FDA approves first prescription eye drop for presbyopia treatment
The FDA approved Allergan’s VUITY (pilocarpine HCL ophthalmic solution) 1.25% as the first prescription drop for treatment of presbyopia. The drop is designed for daily use, beginning to work within 15 minutes of instillation and lasting up to 6 hours, reducing pupil size for improved near vision while maintaining distance vision, according to Allergan’s press release. FDA approval for VUITY was based on two pivotal Phase 3 studies, in which VUITY met its primary endpoint—statistically significant improvement in near vision in mesopic conditions without loss of distance vision compared to vehicle on day 30 at 3 hours after instillation. The most common adverse events, occurring at a frequency of >5% according to the company, were headache and eye redness.
Primary endpoint reached in Phase 2 trial for dry eye disease drug
Aldeyra Therapeutics announced that it achieved its primary endpoint of reduced ocular redness in its randomized, double-masked, vehicle-controlled Phase 2 clinical trial. The trial enrolled 158 participants with dry eye, 80 of whom received 0.25% reproxalap ophthalmic solution and 78 of whom received vehicle. The study had patients take four doses 1 day prior to evaluation and two doses while participants were exposed to a 90-minute “dry eye chamber,” a room with minimal humidity and high airflow while they were performing a visual task. Ocular redness scores in the reproxalap group were statistically lower than the vehicle group, and Schirmer’s scores approached statistical significance in the reproxalap group as well, according to the company’s press release. There were no safety or tolerability concerns, the company reported.
New type of retinal nerve cell discovered
Scientists at the John A. Moran Eye Center, University of Utah, published research in the Proceedings of the National Academy of Sciences about the discovery of a new retinal nerve cell: the Campana cell. The cell is described in a press release from the university as a previously unknown interneuron that relays visual signals from photoreceptors to retinal ganglion cells. The university noted that the exact purpose of these cells is still being researched.
Companies enter collaboration to develop an oral DME, wet AMD treatment
Curacle and Thea Open Innovation announced their licensing and collaboration agreement to develop and commercialize CU06-RE (Curacle), an oral treatment for diabetic macular edema (DME) and wet AMD. According to the companies’ press release, Curacle will develop and conduct the Phase 1 and 2 clinical studies, receiving financial and infrastructure support from Thea Open Innovation. If successful and brought to market, Curacle will retain marketing rights in Asian countries and Thea will have marketing rights elsewhere.
iCare USA acquires remote patient-monitoring tech company
iCARE USA, which is known for its iCARE HOME tonometry device, announced that it has acquired Oculo, a company with telehealth and remote patient-monitoring technology. According to the company’s press release, Oculo has a software platform that allows for secure, HIPAA-compliant communication, including transfer of clinical data and images and video consultations.
ASCRS news and events
- Workplace diversity survey: ASCRS, along with other ophthalmic societies, has been asked to participate in a University of Miami Institutional Review Board-approved study exploring workplace diversity and its role in workplace-related stress. Members are requested to complete a short, 4-minute survey to assist with the study. Results are anonymous.
- ASCRS Journal Club: Plan to join ASCRS’ interactive Journal Club on Tuesday, November 9 from 9:00–10:00 p.m. ET for another session in this monthly series where a panel of experts discuss two pre-selected manuscripts from the Journal of Cataract & Refractive Surgery (JCRS). Learn more.
- 20/Happy in 2021: The popular ASCRS Master Class in Refractive Cataract Surgery is back with a new CME module—20/Happy in 2021—to be hosted in person during the AAO Annual Meeting in New Orleans, Louisiana. If you’re attending the AAO Annual Meeting, join the complimentary program Saturday, November 13, 5:00–9:00 p.m. CT at Hilton Riverside, St. Charles Ballroom. Learn more.
- 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.
Research highlights
- For patients with uncontrolled IOP on maximally tolerated medical therapy, a retrospective study looked at whether the addition of netarsudil was effective. Sixty-two eyes were included in the study with 36 (58%) achieving success (IOP reduction meeting a target) upon the first follow-up visit. Mean baseline IOP was 19.5±5.6 mm Hg on a mean of 3.5±0.7 glaucoma medications. Of those where netarsudil helped achieve success, the mean change in IOP was 5.22 mm Hg. A baseline IOP that was 20 mm Hg or less was associated with greater likelihood of achieving success after the addition of netarsudil. This study is published in the journal Clinical Ophthalmology.
- A meta-analysis of longitudinal cohort studies, which included 14,630 adults with no AMD or only early signs of AMD at baseline, evaluated the impact of physical activity on incidence or progression of the condition. The research published in the American Journal of Ophthalmology stated that the baseline mean age was 60.7±6.9 to 76.4±4.3 years, with a mean prevalence of early AMD of 7.5% (3.6–16.9% between cohorts). No to low/moderate physical activity was associated with an increased risk for incident early AMD; the authors noted that increased risk for late AMD was not associated with physical activity level. There was also no association with age and effect of physical activity on incident AMD. The authors concluded that high levels of physical activity were protective against the development of early AMD in these population-based cohort studies, suggesting that it could be included as part of a prevention strategy.
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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