EW Weekly, August 21, 2020

FDA approves treatment for neuromyelitis
Genentech received FDA approval for Enspryng (satralizumab-mwge) as a treatment for neuromyelitis optica spectrum disorder. The company press release reported that this is the first and only subcutaneous treatment for adults with this condition who are anti-aquaporin-4 (AQP4) antibody positive. The humanized monoclonal antibody is designed to inhibit the receptor that is thought to be involved in inflammation associated with this autoimmune condition that can lead to blindness. According to Genentech, Enspryng is designed to be administered by the trained patient or caregiver in their home every 4 weeks after an initial loading dose. The pivotal clinical trial that led to Enspryng’s approval saw 76.5% of treated patients who are AQP4 antibody positive remain relapse-free at 96 weeks, compared to 41.1% in the placebo group. When used along with baseline immunosuppressant therapy, the company reported research showing Enspryng-treated patients who were AQP4 antibody positive were 91.1% relapse-free at 96 weeks, compared to 56.8% in the placebo group.

Phase 2 program for geographic atrophy gene therapy
Gyroscope Therapeutics initiated a Phase 2 program for a gene therapy to treat geographic atrophy secondary to dry AMD. The gene therapy GT005 is AAV-based and delivered via injection under the retina. The first Phase 2 trial is enrolling patients with a mutation in their complement factor 1 gene with GT005 designed to balance the overactive complement system involved with this mutation, according to the company press release. A second Phase 2 trial that will be initiated later this year will look at a broader group of patients with geographic atrophy.

Allergan to stop producing TrueTear
Allergan announced its decision to stop producing TrueTear. The company is offering patients who purchased the device within the last 3 years a full refund with proof of purchase and returned product. The neurostimulation device was used by dry eye patients who inserted prongs up their nose to electrically stimulate their trigeminal nerve, initiating the production of natural tears. The company stated on its website that its decision to stop manufacturing the device and its removable tips has nothing to do with its safety or efficacy.

20/Happy in 2020: ASCRS launches master class
ASCRS has begun “20/Happy in 2020: The ASCRS Master Class in Refractive Cataract Surgery,” which includes 18 AMA PRA Category 1 CreditsTM as well as non-CME symposia that attendees can view live or watch later. 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 will consist of lectures, audience Q&A, and live panel discussions. Attendees who don’t attend sessions live will have the opportunity to watch recorded versions. Learn more and register at https://ascrs.org/20happy.

Research highlights
  • There are certain patient-related factors that can contribute to surgeon stress during cataract surgery, according to a prospective study published in the journal Clinical Ophthalmology. The study involved a single surgeon recording perceived stress via a surgeon score, qualitative score, and total score. Patient variables that were analyzed alongside surgeon stress were gender, age, diabetes status, morbid obesity, use of alpha blockers, floppy iris, laterality, pseudoexfoliation, IOL power, and preop visual acuity. Data was gathered over 10 years with 1,097 eyes included. According to the study, the surgeon-identified stress was reported in 250 procedures. The following were associated with greater stress levels: patient age of more than 80, presence of morbid obesity, floppy iris syndrome, a severe nuclear sclerotic cataract, and poor baseline distance-corrected visual acuity.
  • A prospective, interventional, non-comparative case series evaluated the outcomes of gonioscopy-assisted transluminal trabeculotomy (GATT) in eyes with pseudoexfoliation glaucoma over a period of 24 months. The case series, published in the British Journal of Ophthalmology, included 103 eyes from 84 patients whose mean preop IOP was 27.1 mm Hg with 2.9 glaucoma medications. The mean IOP decreased postop to 13 mm Hg with 1 medication at 24 months of follow-up. This, the study authors reported, showed an 89.2% success rate of the GATT procedure, which saw a 2.9% complication rate. The authors concluded that the procedure, which is conjunctival sparing, effectively lowered IOP and reduced medication burden in a “relatively aggressive glaucoma subtype.”
  • Two-year outcomes of transepithelial accelerated corneal crosslinking in 24 eyes of 24 patients with progressive keratoconus was found to be safe and effective, though some patients continued to progress, according to research published in Clinical Ophthalmology. The retrospective interventional study did not see any complications during or after the procedure. Progression was determined by an increase of 1 or more diopters of maximum keratometry, an increase of 1 or more diopters of corneal astigmatism, a decrease of 2% or more of the thinnest corneal thickness, or an increase of 0.42 or more in D-index. Per these parameters, the researchers found between 11–33% of patients showed disease progression at 24 months postop. The study authors recommend longer follow-up and larger patient cohorts for future studies.
  • A literature review sought to identify the etiology, incidence, and clinical/surgical management of positive and negative pseudophakic dysphotopsia. Several articles, according to the study authors, related positive dysphotopsia to internal reflection of oblique light rays off square edges of IOLs, reflecting back to the retina. The authors noted that there currently are no round edge, foldable IOLs in the U.S. Other factors contributing to positive dysphotopsia included high index of refraction, surface reflectivity, and optic design. Negative dysphotopsia, according to four articles that used ray tracing optical modeling, “suggested an ‘illumination gap’ where some temporally incident light rays to the nasal retina pass anterior to the IOL and some are refracted posteriorly by the IOL, resulting in a ‘gap’ and resultant temporal shadow,” the authors said. The authors noted that two papers describe a new optic that captures the anterior capsulotomy, similar to reverse optic capture, which they report is successful in treating patients with negative dysphotopsia. This research is published in the journal Ophthalmology.

Product news
  • Haag-Streit introduced its CO:RE Surgical Chair, designed with ophthalmologist ergonomics in mind.
  • BVI launched iPure, an aspheric monofocal, preloaded one-piece and three-piece IOL, its first IOL available in the U.S.
  • Johnson & Johnson Vision launched two presbyopia-correcting IOLs—TECNIS Synergy and TECNIS Eyhance—in Canada.

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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