EyeWorld Weekly, November 19, 2021

November 19, 2021 • Volume 27, Number 46

New 5-year data with MIGS device

Ivantis announced new data from its 5-year HORIZON pivotal trial, showing that use of the Hydrus Microstent lowers the rate of visual field loss by 47% compared to the rate with cataract surgery alone. The company’s press release described this as the first glaucoma procedure to reduce vision loss compared to standard medical treatment in a large randomized clinical trial since trabeculectomy. This new data comes in addition to previous findings from the HORIZON trial, the largest prospective, randomized controlled trial for a MIGS device and the first with continuous 5-year follow-up data. Other findings included that 73% of participants on one glaucoma medication at baseline who received Hydrus remained medication-free at 5 years (48% in this category were medication-free with cataract surgery alone). There was a 20–30% improvement in the medication-free rate in the Hydrus group at all time points, and patients in the Hydrus group were 2.8 times less likely to need subsequent invasive glaucoma surgery, according to the company.

Back to top

Phase 2 results with new epi-on crosslinking technology

CXL Ophthalmics announced topline results from its landmark Phase 2 clinical trial of epi-on crosslinking with its EpiSmart system, which includes Ribostat, a riboflavin formulation designed to optimize epi-on crosslinking. The study included 2,258 participants with corneal ectasia who were put into one of three groups with different treatment duration and energy parameters; 70% of patients had simultaneous bilateral treatment for keratoconus. The average patient age was 32, with a range of 8–79 years old, average baseline vision was 20/40 corrected and 20/130 uncorrected, and average Kmax was 59±10 D. Of the 1,605 keratoconus subjects with complete baseline assessments, 1,400 completed 6-month postop outcome efficacy assessments and 784 were assessed to 12 months, according to the company. The overall mean change in CDVA was –0.063 and –0.068 logMAR at 6 and 12 months, respectively. Group 1, treated with 4 mW/cm2 for 20 minutes (the lowest dose), achieved a –0.074±0.012 logMAR change in baseline CDVA at 12 months. According to the company’s press release, 81% of keratoconus patients maintained or improved their vision, with 14% gaining three lines or more CDVA. Eighty-nine percent of patients 21 years old and younger in group 1 had stable or improved vision, with 25% gaining three or more lines CDVA. UDVA overall improved by one line of vision at 6 and 12 months, and Kmax was significantly flattened by –0.45±0.09 D at 12 months overall. There were no serious adverse events related to the treatment; 8.7% of patients reported mild, transient treatment-emergent adverse events, including mild corneal epithelial defects, MGD, punctate keratitis, and dry eye. The company is planning to begin Phase 3 clinical trials with the EpiSmart system.

Back to top

FDA grants IDE, authorizes trial of new viscodilation system

Sight Sciences announced that the FDA granted an investigational device exemption (IDE) and authorized the company to conduct a clinical safety and efficacy study for its new, higher volume OMNI device, which is designed to dispense 21 mL of viscoelastic fluid during a canal viscodilation procedure to lower IOP in adults with POAG. According to the company’s press release, the PRECISION trial is designed as a three-arm randomized controlled trial that will evaluate the higher volume OMNI procedure plus cataract surgery, iStent inject (two stents, Glaukos) plus cataract surgery, and canaloplasty alone with the higher volume OMNI system.

Back to top

Robotic surgery for glaucoma

New York Eye and Ear Infirmary of Mount Sinai announced development of a robotic surgical system for glaucoma and retina procedures. Sean Ianchulev, MD, in a video announcement described it as the first system of its kind that can achieve single-micron precision of 1–2 microns. He said this is an increase of 20–30x in surgical precision. The robotic software has both retina and glaucoma technologies that Dr. Ianchulev said they hope to move into trials for possible FDA approval in the future.

Back to top

First patient dosed in Phase 3 trial of investigational drop for DME

Oculis announced that the first patient was dosed in its Phase 3 DIAMOND trial, designed to evaluate the safety and efficacy of OCS-01, a topical, preservative-free drop. According to the company, the drop was designed to possibly treat all stages of DME. In a Phase 2 study, the drop was shown to improve visual acuity and reduce central macular thickness in DME patients compared to vehicle.

Back to top

New glaucoma device approved in European market, plus Phase 2 results

iSTAR Medical announced approval of its MINIject MIGS device for OAG in Europe. It also presented 2-year results from its Phase 2 study in patients with POAG with mean IOP reduced 36% from 24.6 mm Hg at baseline to 15.5 mm Hg at 2 years follow-up. There was a 52% reduction in medication use according to the company, from 2.9 medications at baseline to 1.4 at trial completion. The company stated that corneal health evaluation demonstrated long-term safety as well. Interim data from the company’s 3-year study also maintained similar safety and efficacy results.

Back to top

ASCRS news and events

  • 2022 ASCRS Annual Meeting: Registration for the ASCRS Annual Meeting in Washington, D.C., April 22–26, 2022, is now open. 
  • ASCRS Grand Rounds: The next ASCRS Grand Rounds presented by the University of Iowa Department of Ophthalmology and Visual Sciences will become available on Tuesday, November 30. 
  • 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.

Back to top

Research highlights

  • A population study of patients in the U.K. national ophthalmic cataract database evaluated the effect of patient age, gender, comorbidities, and surgeon on refractive outcomes. The data included 490,987 cataract surgeries (351,864 patients) performed by 2,567 surgeons from April 2010 through August 2018. Myopic and astigmatic errors were associated with posterior capsule rupture, glaucoma, and previous vitrectomy, according to the paper. Hyperopic and astigmatic errors were associated with diabetic retinopathy, male gender, and age. The authors reported that inherited retinal disease, optic nerve disease, previous trabeculectomy, uveitis, and brunescent or white cataract did not have a significant impact on errors in refractive outcomes. They also noticed that gender and comorbidity was additive. The surgeon accounted for 4% of explained variance. With this, the authors concluded that “patient comorbidities and gender account for small but statistically significant differences in refractive outcome,” while the “surgeon effects are very small.” The research is published in the British Journal of Ophthalmology
  • A longitudinal, retrospective cohort study investigated five different single-piece IOL platforms and Nd:YAG capsulotomy incidence at 3 years post-cataract surgery. The data was from EMRs from two large regional hospitals in Spain and included the AcrySof (Alcon), LLASY60 (AJL), Bi-Flex (Medicontur), Asphina (Carl Zeiss Meditec), and Stabibag (IOL Tech). More than 14,500 eyes were included in the analysis. The Nd:YAG capsulotomy incidence for AcrySof was 5% and, according to the authors, ranged from 21.2% to 31.1% for the other IOLs. The authors concluded that these capsulotomy rates “support the importance of lens choice in reducing patient burden and treatment costs.” The research is published in the journal Eye.

Back to top


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

For sponsorship opportunities or membership information, contact: ASCRS • 12587 Fair Lakes Circle • Suite 348 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ascrs@ascrs.org

Mention of products or services in EyeWorld Weekly does not constitute an endorsement by ASCRS.

Click here to view our Legal Notice.

Copyright 2021, EyeWorld News Service, a division of ASCRSMedia. All rights reserved.