EW Weekly, November 6, 2020

FDA approves new green laser photocoagulator
Norlase announced FDA 510(k) clearance and commercial launch of LION, a green laser photocoagulator integrated into the Keeler indirect ophthalmoscope. The company’s press release explained that LION does not have a fiber tether and is battery powered, using a wireless interface with optional voice control. These features make the technology lightweight and portable in “practically any setting,” according to Norlase.

Phase 3 clinical trial started for presbyopia-correcting eye drop
Orasis Pharmaceuticals announced initiation of two Phase 3 clinical trials in the U.S. to evaluate an eye drop to treat presbyopia symptoms. The NEAR-1 and NEAR-2 clinical trials are multicentered, double-masked, parallel-group, and will enroll about 600 people with presbyopia to evaluate safety and efficacy. According to the company’s press release, promising results were seen in the Phase 2b study.

Phase 2b trial initiated for dry eye disease drop
Aerie Pharmaceuticals announced the start of its COMET-1 Phase 2b clinical trial of AR-15512, a TRPM8 agonist. The trial, according to the company’s press release, will enroll about 360 patients who will receive either AR-15512 0.0014%, AR-15512 0.003%, or AR-15512 vehicle. The drops will be dosed twice daily in each eye for 3 months. Primary efficacy endpoints are ocular discomfort and tear production, according to Aerie. Efficacy will be assessed at day 14, 28, and 84. Topline results are expected in the third quarter of 2021.

Phase 2/3 clinical trial for DED drop did not achieve clinical significance in primary endpoint
Aurina Pharmaceuticals announced topline data for its Phase 2/3 AUDREY clinical trial that evaluated voclosporin ophthalmic solution for dry eye disease (DED). Most notably statistical significance was not found in its primary endpoint, which was 10 mm or more improvement in Schirmer scores at 4 weeks in the dose groups compared to vehicle. The company stated that it is suspending its development program for this solution based on these results.

Novartis acquires company with platform for AAV-based gene delivery
Novartis acquired Vedere Bio and in doing so acquired a platform for adeno-associated virus (AAV)-based gene delivery and an optogenetics program. According to the company’s press release, this builds on the company’s established commitment to cell and gene therapy.

ASCRS Foundation grant applications closing soon
The ASCRS Foundation has two grant opportunities that are open through November 16. One is the 2021 ASCRS Foundation Young Eye Surgeon International Service Grant, which provides up to $5,000 in funding for grantees to initiate a global service project. The funds will allow recipients to begin their project at home in 2021 with the opportunity to travel when safe and feasible, allowing them to see their project in action by the end of 2022. This opportunity is for ASCRS members who are third-year residents, fellows, or those within their first 5 years of practice. More information about the Young Eye Surgeon International Service Grant can be found here. The second is the Chang-Crandall Humanitarian Award, a $50,000 award endowed by David Chang, MD, and his wife, Victoria Chang, and recently renamed in recognition of Alan Crandall, MD, who lived an exemplary life committed to charitable eyecare service. This award is given annually to an individual for their inspirational accomplishments in the U.S. or internationally for charitable eyecare, with a focus on cataract blindness. The recipient is recognized at the ASCRS Annual Meeting and the prize is awarded to a charitable ophthalmology organization of the recipient’s choice. Submit a nomination for the Chang-Crandall Humanitarian Award by November 16 here.

20/Happy in 2020: ASCRS continues master class
This weekend ASCRS continues its “20/Happy in 2020: The ASCRS Master Class in Refractive Cataract Surgery,” which includes 18 AMA PRA Category 1 Credits as well as non-CME symposia that attendees can view live or watch later at their own pace. Every other week, live symposia will be aired on Saturdays, avoiding conflicts with clinic and OR time. At the conclusion of the multi-week master class, participants will receive a frameable certificate. A total of nine CME modules will cover topics including preoperative diagnostics, IOL calculations, IOL design, patient selection, education, and counseling, efficiency, and more, with discussion and expertise provided by a faculty of 80 surgeons from around the world. Sessions consist of lectures, audience Q&A, and live panel discussions. Those who don’t attend sessions live will have the opportunity to watch recorded versions. This Saturday, November 7 features module 7, a session on “Adjunct Refractive Cataract Technology—What Do I Really Need.” Learn more and register at https://ascrs.org/20happy.

Research Highlight
  • An ancillary study of the Vitamin D and Omega-3 Trial (VITAL) evaluated how these supplements affected development or progression of AMD. The research published in JAMA Ophthalmology included 25,871 U.S. adults who were randomized to take daily vitamin D3, 2000 IU, and marine omega-3 fatty acids, 1 g, or placebo. The researchers found that in a median of 5.3 years, this supplementation did not have an effect on the total AMD events, which was a composite of AMD incidents and progression to advanced AMD.
  • Topical and peribulbar anesthesia for phacoemulsification were compared in a prospective, randomized, comparative observational study of 110 eyes. Researchers found in inter-group comparisons that anterior chamber depth was greater in the group that received peribulbar anesthesia. Postop refractive outcomes were better for those under topical anesthesia. The results are published in Clinical Ophthalmology.
  • SMILE, as approved by the FDA, is contraindicated in eyes with a central corneal thickness less than 500 µm. Researchers at the Beyoglu Eye Training and Research Hospital in Istanbul, Turkey, evaluated SMILE’s safety and efficacy in 55 eyes of 39 patients with central corneal thicknesses of less than 500 µm. The mean preop UCDVA was 1.3±1.5 logMAR and postop was 0.05±0.80 logMAR. At the last postop visit, higher order aberrations (coma, secondary astigmatism, spherical aberration, and RMS) increased from baseline. There were no sight-threatening complications or ectasia after at least 24 months of follow-up. The study authors concluded that SMILE, even in thinner corneas, can be safe and effective. They noted that candidates should have normal preop corneal topography. This study is published in the journal Eye.

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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