Alert: eye infections linked to artificial tear

The CDC issued an alert urging clinicians and patients to stop using EzriCare Artificial Tears as it investigates eye infections that seem to have a link with use of this product. According to the CDC’s alert, from May 17, 2022, to January 19, 2023, the CDC with local and state health departments identified 56 isolates from 50 cases in 11 states that have had carbapenem‐resistant Pseudomonas aeruginosa infections (10 specimens were collected from the cornea, others were non-ocular specimens). Use of artificial tears (most commonly the EzriCare Artificial Tears, which is a preservative-free product in multidose bottles) was common among the patients. The CDC reported finding carbapenem‐resistant Pseudomonas aeruginosa in unopened bottles of EzriCare Artificial Tears upon investigation. The CDC’s investigation into this cluster outbreak is ongoing.

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Phase 2 data from research targeting Sjogren’s treatment

Horizon Therapeutics announced that it had met its primary endpoint for a secondary population in its Phase 2 trial of dazodalibep for Sjogren’s disease. This second patient population included patients with moderate-to-severe symptoms (dryness, pain, fatigue) without other organ involvement (patients with a European Alliance of Associations for Rheumatology [EULAR] Sjogren’s Syndrome Patient Reported Index score of 5 or more and less than 5 on the EULAR Sjogren’s Syndrome Disease Activity Index). At day 169 of the study, patients treated with dazodalibep showed a 1.8-point reduction in their patient-reported scores compared to those on placebo (0.53-point reduction). The company noted that positive results in the first patient population (patients with moderate-to-severe symptoms and at least one organ system involved) were reported in 2022. According to the company’s press release, dazodalibep is the only investigational treatment thus far to meet primary endpoints in these patient populations at a Phase 2 stage. The company described dazodalibep as “a CD40 ligand antagonist that blocks T cell interaction with CD40-expressing B cells, disrupting the overactivation of the CD40 ligand co-stimulatory pathway.” Overactivation of this pathway is associated with other autoimmune diseases as well. The company stated that it plans to work with the FDA on a Phase 3 clinical program this year.

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First patient dosed in Phase 1 study for epithelial defect treatment

Trefoil Therapeutics has dosed the first patient in its Phase 1 safety study evaluating TTHX1114 for the treatment of epithelial defects. TTHX1114, in this study, is designed as a topical drop formulation that will stimulate fibroblast growth factor-1 for cell proliferation and migration. Trefoil, in a separate clinical program, is evaluating intracameral injection of TTHX1114 for Fuchs and other corneal endothelial dystrophies, with the goal of corneal endothelial cell protection and proliferation. A Phase 2 study with the intracameral formulation has been completed with positive data presented in 2022.

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Study compares DMEK tissue preparation techniques

Researchers at the Sue Anschutz-Rodgers Eye Center compared endothelial cell loss with two preparations of DMEK tissue in a study that was recently published in the journal Cornea. According to the news article from the eye center, the study evaluated cell loss using the modified Jones tube for tissue preparation, which is the more traditional technique, and DMEK EndoGlide (Coronet) with and without viscoelastic material, which is a newer technique. The study, which was ex vivo, included 10 DMEK grafts for each of the three preparation techniques (30 total graft preparations); the investigators simulated transportation conditions for at least 45 hours before deploying the tissue and quantifying endothelial cell loss. According to the paper, the Jones tube group had a mean endothelial cell loss of 11.0±4.8% compared to 12.9±6.7% in the EndoGlide group. There was no statistically significant difference between the Jones tube preparation or the EndoGlide. The EndoGlide preparation with and without viscoelastic showed statistically significant differences; the authors reported that the group with viscoelastic showed endothelial cell loss in the area with viscoelastic use. Researchers in the news article from the eye center stated that this is the first direct comparison of the two preparation methods. The EndoGlide, the researchers said, can provide more control and could result in better long-term outcomes.

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Topline results from oral diabetic retinopathy treatment trial

Ocuphire Pharma has announced positive topline results from its Phase 2 trial evaluating an oral treatment for diabetic retinopathy. According to the company’s press release, oral APX3330 achieved statistical significance on the secondary endpoint of preventing progression of diabetic retinopathy after 24 weeks of treatment. It also showed favorable safety and tolerability as a non-invasive treatment option. The company stated that while APX3330 did not meet its primary endpoint—”% of patients with a ≥ 2-step improvement in [diabetic retinopathy severity score] at week 24 in the study eye”—it noted that it’s important to evaluate the effect on both eyes, given that the treatment is oral. Thus, the press release continued, a potential Phase 3 registration primary endpoint could be “≥ 3-step worsening of DRSS as a composite of both eyes (binocular).” Analysis of the Phase 2 data is ongoing.

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ASCRS news and events

• ASCRS Annual Meeting: Tier 1 registration pricing for the ASCRS Annual Meeting, May 5–8, 2023, in San Diego, California, ends January 31. Register now for the best value to attend the meeting.
• New—ASCRS Annual Meeting Preview Program: The ASCRS Annual Meeting Preview Program is now available online.
• Annual Meeting submission opportunity: Three symposia at the ASCRS Annual Meeting are seeking video case submissions now through February 1. Find more information here.

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Research highlights

• Visual quality after femtosecond laser-assisted cataract surgery (FLACS) and traditional phacoemulsification cataract surgery with an EDOF IOL were evaluated in a prospective cohort study published in the Journal of Cataract & Refractive Surgery. Two hundred and sixty-one patients were included in the study. The authors found that the circularity index with FLACS was more precise and IOL decentration and tilt was lower with FLACS. The authors also reported lower total aberrations, higher order aberrations, coma, and spherical aberrations with FLACS. Better outcomes were observed in the FLACS group at a defocus curve of –1 D, as well as in terms of contrast sensitivity and other photic phenomenon. With this, the authors concluded that FLACS shape and size of the capsulotomy could result in better IOL centration, equating to better visual performance.
• The safety and efficacy of crosslinking to reduce progression and improve visual acuity in a pediatric population with progressive keratoconus was evaluated in a study with long-term (7-year) follow-up. The prospective, clinical study published in the American Journal of Ophthalmology included 74 eyes of 58 patients who had a standard crosslinking procedure with either 20% dextran-based riboflavin or 1% hydroxypropyl methylcellulose-based (HPMC) riboflavin and completed follow-up out to 7 years. The authors reported that UDVA and CDVA improved at all follow-up periods, with statistically significant differences in CDVA at 1, 2, and 3 years. Over the 7-year follow-up, max K was reduced compared to baseline, and the mean thinnest pachymetry decreased at 3 months and remained low. According to the authors, 1.5 D progression in max K was 1.4–14.6% after crosslinking with “worsening” between 4–7 years postop. Overall, 82% of eyes showed reduced progression and improvement/stability of UDVA and CDVA with crosslinking. There was no statistically significant difference between the two riboflavin formulations investigated for visual acuity and keratoconus stability, but the authors wrote that the corneal thinning in the hydroxypropyl methylcellulose-based riboflavin group “[raised] concerns about its use in [crosslinking].”

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Product news

• Harrow acquired exclusive rights to the following brand name products: ILEVRO, NEVANAC, VIGAMOX, MAXIDEX, and TRIESENCE.
• Topcon Healthcare received ISO 27001 certification, affirming the level of data security and integrity, for its Harmony RS Clinical Data Management System.

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