EyeWorld Weekly, April 1, 2022

EyeWorld Weekly, April 1, 2022

EyeWorld Weekly

April 1, 2022 • Volume 28, Number 13

FDA approves new ICL

STAAR Surgical announced FDA approval of its EVO/EVO+ Visian Implantable Collamer Lens (ICL) for correction of myopia and myopia with astigmatism. The EVO is implanted in the posterior chamber. According to the company’s press release, earlier versions of the Visian ICL required a peripheral iridotomy; that is not required with the EVO. The EVO is indicated for patients 21–45 years old for correction of myopia from –3 D to –20 D at the spectacle plane. It can correct between 1–4 D of cylinder. Patients should have an anterior chamber depth of 3 mm or greater, measured from the corneal endothelium to the anterior surface of the crystalline lens, and refractive history should be stable within the year prior to implantation, according to the company.

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Home tonometer receives 510(k) clearance

The FDA granted 510(k) clearance to the self-tonometer iCare HOME2 (Icare USA). According to the company’s press release, this is the latest generation of the device that allows patients to measure their own IOP outside of clinic hours, providing real-world data on peak and fluctuation patterns. The system features a smart light guide for patient use, an interactive display screen, cloud-based software for data storage, and a mobile app (PATIENT2) for data sharing. iCare HOME2 can be used by the patient while he or she is laying down, reclined, or sitting.

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First patient treated in what will be the largest standalone MIGS clinical trial

Sight Sciences announced that the first patient has been treated in its TRIDENT clinical trial, taking place in Europe, comparing the OMNI Surgical System (Sight Sciences) as a standalone treatment to the iStent inject (Glaukos) in patients with open angle glaucoma. The trial is prospective, randomized, multicentered, and will compare safety and efficacy. The trial has three study arms, according to the company: 1) canaloplasty alone using the OMNI Surgical System, 2) sequential canaloplasty followed by trabeculotomy using the OMNI Surgical System, and 3) implantation of two trabecular microbypass canal implants (iStent inject). The study will use the next-generation OMNI Surgical System, which, according to the company’s press release, dispenses a higher volume of viscoelastic fluid than the generation that’s currently marketed. The company stated that it will enroll 459 subjects who will be randomized into the three study arms, making it the largest standalone MIGS clinical trial to date.

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Topline results from second Phase 3 trial of mydriasis-reversing drug

Ocuphire Pharma announced topline results from its second Phase 3 trial of Nyxol, a phentolamine mesylate drop being investigated for reversal of pharmacologically induced mydriasis. In this latest trial, 58% of subjects treated with the drop returned to 0.2 mm or less of their baseline pupil diameter after 90 minutes, compared to 6% treated with placebo; 42% of eyes treated with Nyxol returned to near baseline within 60 minutes compared to 2% treated with placebo. At 6 hours, according to the company’s press release, only 36% of eyes treated with placebo had returned to their baseline pupil diameter. The company stated that it plans to file an NDA with the FDA late this year.

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ASCRS news and events

  • 2022 ASCRS Annual Meeting: Register for the ASCRS Annual Meeting in Washington, D.C., April 22–26. Read this Q&A with EyeWorld Chief Medical Editor Eric Donnenfeld, MD, and ASCRS Program Chair Edward Holland, MD. 
  • Eyecelerator@ASCRS: Registration is open for Eyecelerator@ASCRS, taking place April 21 ahead of the ASCRS Annual Meeting in Washington, D.C. 
  • ASCRS Grand Rounds: The first ASCRS Grand Rounds of 2022, presented by NYU Langone Department of Ophthalmology, is available on demand. 
  • Ophthalmology Quicksand Chronicles: Watch the latest episode of this popular ASCRS podcast hosted by Nicole Fram, MD, and Elizabeth Yeu, MD, with guest Amar Agarwal, MD.

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Research highlights

  • The impact of Graves’ disease on the ocular surface was researched in a study published in the journal Cornea. The study included 34 patients with Graves’ disease (18 with Graves’ orbitopathy with inactive disease and 16 without Graves’ orbitopathy; 24 age-matched controls were included for comparison). According to the paper, patients with Graves’ disease had a higher proportion of clinical dry eye disease diagnoses—77.77% with Graves’ orbitopathy, 75.0% without Graves’ orbitopathy, and 4.17% controls without Graves’ disease. Patients with Graves’ disease were more likely to have a higher OSDI and a lower tear film breakup time. Superior corneal epithelial thickness was lower in patients with Graves’ disease. The authors noted that eye dryness and corneal thinning was not different between Graves’ patients with and without orbitopathy. These findings, the authors continued, could “[suggest] that subclinical chronic inflammation may play a role in the pathogenesis of tear film and ocular surface stability.” 
  • The efficacy of thin and ultrathin DSAEK (T-DSAEK and UT-DSAEK) was evaluated in a systematic review and meta-analysis. The analysis was grouped into graft thicknesses of <80 μm, 80–100 μm, and 100–130 μm. Forty-seven articles were included in the analysis, totaling 2,141 eyes of 2,040 patients. Overall, the authors found that visual acuity improved regardless of difference in graft thickness. The authors also noted that pachymetry, endothelial cell count, and rejection and rebubbling rates were similar among the groups, regardless of graft thickness. There was a hyperopic shift, however, in grafts >100 μm. This study was published in the American Journal of Ophthalmology.

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Product news

  • XIPERE (triamcinolone acetonide suprachoroidal injectable suspension, Bausch + Lomb) began its commercial launch as a treatment for macular edema associated with uveitis. 
  • Haag-Streit introduced its Imaging Module 910 slit lamp, which has imaging capabilities in order to facilitate slit lamp documentation.

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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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