EyeWorld Weekly, April 15, 2022

EyeWorld Weekly, April 15, 2022

EyeWorld Weekly

April 15, 2022 • Volume 28, Number 15

Phase 3 clinical trials complete for ‘superpotent’ corticosteroid

Salvat, a European manufacturer with a subsidiary in the U.S., completed Phase 3 clinical trials for treatment of inflammation and pain after cataract surgery with clobetasol, which the company’s press release described as a “superpotent” corticosteroid. The company stated that this is the first time clobetasol as an active ingredient has been used in ophthalmology. Two clinical trials were conducted with more than 400 patients in the U.S. in 2020 and 2021 at more than 40 centers. The data showed that the steroid was safe, effective, did not increase IOP, and showed a statistically significant difference compared to placebo. It also doesn’t require a taper at the end of treatment, the company stated. No rebound inflammation or pain was observed. The corticosteroid was tested with the company’s nanoemulsion technology (IMPACT-SVT), which the company said delivers the drug at a low concentration, resulting in a more comfortable patient experience. Salvat stated that it has begun application procedures for approval with the FDA and in Europe; it plans to launch this product within the second half of 2023.

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New rapid, quantitative MMP-9 tear test

AXIM Biotechnologies announced its development of a rapid, quantitative tear test for MMP-9, an inflammatory biomarker for dry eye disease. According to the company’s press release, this type of test could be used for the diagnosis of dry eye disease and inform subsequent treatment planning.

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First pediatric patient dosed with experimental gene-editing therapy for Leber congenital amaurosis

Editas Medicine announced that it dosed its first pediatric patient with EDIT-101, an experimental CRISPR gene-editing medicine designed for the treatment of Leber congenital amaurosis 10. The company’s press released stated that this is the first time a pediatric patient has received in vivo dosing of a CRISPR gene-editing experimental medicine. According to the company, EDIT-101 is delivered via subretinal injection, and it has designations as a rare pediatric disease and orphan drug from the FDA. The company is conducting mid-dose and high-dose pediatric testing of the experimental therapy. It previously completed dosing in an adult cohort, finding a favorable safety profile and “encouraging signals of clinical benefit.”

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Study: Comparison of NCX 470 to latanoprost for glaucoma

A randomized, controlled study compared NCX 470 ophthalmic solution (Nicox) at three concentrations (0.021%, 0.042%, and 0.065%) to latanoprost 0.005% in patients with open angle glaucoma or ocular hypertension. The study, published in the Journal of Glaucoma, showed that NCX 470 0.065% was statistically superior to latanoprost, with a peak improvement of IOP lowering of 1.4 mm Hg greater. The company’s press release stated that all concentrations of NCX 470 were non-inferior to latanoprost, and IOP lowering improved with each incremental concentration increase of NCX 470. The study drug was safe and well tolerated with no serious adverse effects and no treatment-related systemic side effects, according to the company. NCX 470, according to the press release, is currently in Phase 3 clinical trials. NCX 470 is described by Nicox as a novel, nitric oxide-donating prostaglandin analog, designed to release both bimatoprost and NO upon instillation.

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Collaborations for inherited retinal diseases

Several companies recently announced their collaborations/agreements in an effort to better target treatments for inherited retinal diseases. Opus Genetics entered into a strategic manufacturing services agreement with National Resilience to develop a first-in-human material for Opus’ AAV vector-based gene therapy. Separately, Mireca Medicines entered into an exclusive partnership with Graybug Vision to develop cGMP analogues; Graybug will gain access to Mireca’s protein kinase G modulators library and will be responsible for research, development, manufacturing, and commercialization of these cGMP analogues, according to the company’s press release.

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ASCRS news and events

  • 2022 ASCRS Annual Meeting: The ASCRS Annual Meeting in Washington, D.C., begins in one week! Find day-by-day highlights here. 
  • Eyecelerator@ASCRS: Eyecelerator@ASCRS is next week, April 21, in Washington, D.C. 
  • ASCRS Grand Rounds: ASCRS Grand Rounds, 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

  • Long-term IOP control after clear lens extraction (CLE) or laser peripheral iridotomy (LPI) in patients with primary angle closure was assessed with data from the Effectiveness of Early Lens Extraction for the Treatment of Primary Angle-Closure Glaucoma trial. This secondary analysis defined “good responders” as those with an IOP of less than 21 mm Hg without additional surgery and “optimal responders” as those who also had an IOP less than 21 mm Hg on no medications. There were 182 CLE patients and 187 LPI patients who completed the 36-month follow-up exam. In the CLE arm, 90% were “good responders” and 66% were “optimal responders.” In the LPI arm, 67% were “good responders” and 18% were “optimal responders.” The authors concluded that patients with primary angle closure glaucoma and primary angle closure were 10 times more likely to be drop-free with good IOP control with CLE compared to LPI. Predictors for a worse long-term IOP response included non-Chinese ethnicity, higher baseline IOP, and use of glaucoma drops prior to randomization. This research is published in the British Journal of Ophthalmology. 
  • The possibility of using a deep learning algorithm to help rapidly distinguish between fungal keratitis vs. bacterial keratitis was assessed in a paper published in the journal Cornea. More than 2,100 anterior segment images were included in the analysis, split into training, validation, and test sets. Three convolutional neural networks—VGG19, ResNet50, and DenseNet121—were trained to classify the images and performance of each was evaluated. The authors concluded that a convolutional neural network with ensemble learning had the best performance in distinguishing between the two conditions, compared to single architecture models. They stated that the model could be considered as an adjunctive tool for rapid, provisional diagnosis of patients with microbial keratitis.

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Product news

  • Alcon launched the Fidelis Virtual Reality Ophthalmic Surgical Simulator, a portable virtual reality tool for cataract surgery training. 
  • Bruder introduced new in-office package options for offering its Bruder Moist Heat Eye Compress.

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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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