EW Weekly, August 2, 2019

2020 Medicare Physician Fee Schedule (MPFS) proposed rule released
The Centers for Medicare & Medicaid Services (CMS) released the CY 2020 MPFS Proposed Rule, which includes revalued cataract codes. It will be published in the Federal Register on August 14, 2019, with a 60-day comment period. Key information about the proposed rule for anterior segment surgeons is available here, and ASCRS Director of Government Relations Nancey McCann discusses it in an ASCRS Government Relations Special Report.

J-code announced for YUTIQ
A specific and permanent J-code has been assigned for YUTIQ (fluocinolone acetonide intravitreal implant, EyePoint Pharmaceuticals) 0.18 mg by CMS, according to a company press release. The code, J7314, becomes effective on October 1. YUTIQ is designed to treat chronic, noninfectious uveitis that affects the posterior segment. It was approved by the U.S. FDA on Oct. 12, 2018.

Enrollment begins in Phase 3 trial of nasal spray treatment for dry eye
The first subject has been enrolled in the Phase 3 ONSET-2 clinical trial of OC-01 nasal spray (Oyster Point Pharma) to treat the signs and symptoms of dry eye disease, according to a company press release. ONSET-2, which follows the Phase 2b clinical trial ONSET-1, is a multicenter, randomized, double-masked, placebo-controlled trial that evaluates the safety and efficacy of the spray. It will enroll an estimated 750 subjects at 20 centers around the U.S. and investigate 0.6 mg/ml and 1.2 mg/ml doses of OC-01 compared with placebo. The primary endpoint will be assessment of tear production as measured by the percentage of subjects with a 10 mm or larger change from baseline Schirmer’s score at week 4. The secondary endpoint will be assessment of patient-reported dry eye symptoms as measured with the Eye Dryness Scale at week 4.

First U.S. clinical trial for Technolas Teneo laser initiated
Bausch + Lomb has begun the first of a series of U.S.-based clinical trials to evaluate the safety and efficacy of the Technolas Teneo excimer laser for vision correction surgery for myopia and myopic astigmatism, the company reported. The multicenter, prospective, open-label, non-randomized pivotal clinical trial will evaluate the effectiveness of the Technolas Teneo 317 (model 2) in LASIK. A safety and efficacy evaluation will take place when refractive stability is achieved.

Patient-focused Executive Summary of TFOS DEWS II available
A patient-focused Executive Summary of the 2017 TFOS DEWS II report is now available on the Tear Film and Ocular Surface Society (TFOS) website, according to a press release from TFOS. The summary addresses the extensive dry eye research done as part of TFOS DEWS II. The summary is written in lay language and has new figures related to the classification and pathophysiology of dry eye disease.

PRIME access granted by EMA for sepofarsen for Leber’s congenital amaurosis
Sepofarsen (QR-110, ProQR Therapeutics) was granted access to the PRIority MEdicines (PRIME) program by the European Medicines Agency (EMA), according to a company press release. The drug candidate is under development to target the p.Cys998X mutation in the CEP290 gene to treat Leber’s congenital amaurosis 10. This is the first EMA PRIME access that ProQR has been granted for its portfolio of RNA product candidates for inherited retinal diseases, the company reported.

Research briefs
  • In a prospective, observational, comparative study, only a small amount of clinically insignificant aberrations were induced through the use of high-powered positive IOLs, reported Renan Oliveira, MD, and coresearchers. Additionally, low-powered IOLs did not induce significant levels of spherical aberrations. The study included patients who had cataract surgery with implantation of a spherical monofocal IOL. Among the three groups of patients, Group 1 included patients with IOLs of +20 D to +23 D; Group 2, less than +10 D; and Group 3, +29 D or more. A total of 88 eyes of 56 patients were included. The groups had no differences in refractive error, corneal aberrometry, or total ocular higher-order aberrations at any pupil diameter. Ocular spherical aberration was not significantly different between groups with a 4-mm pupil. However, the spherical aberration was significantly lower in Group 2 compared with Groups 1 and 3 for 4.5 mm and 5 mm. No significant difference in spherical aberration between Groups 1 and 3 occurred at any analyzed pupil diameter. Higher spherical aberration did not correlate with lower contrast sensitivity. The study is published in the Journal of Cataract & Refractive Surgery .
  • Parental myopia, age at baseline, progression of myopia in the first post-onset year, and more time spent on reading/close work and less on outdoor activities as a child all were associated with high myopia in adulthood, according to Olavi Parssinen, MD, and coresearchers. Their 22-year follow-up study focused on 240 myopic schoolchildren (119 boys and 121 girls) with a mean age of 10.9 years who were recruited to a randomized clinical trial of myopia. All were referred for an eye exam due to poor distance vision. Regular clinical follow-ups were scheduled, and factors such as parental myopia, time spent on reading, watching TV, and outdoor activities were measured with a questionnaire. Researchers also analyzed the influence of different definitions of high myopia. The mean spherical equivalent at baseline was —1.43 D; at the follow-up end, the mean spherical equivalent of the more myopic eye was —5.29 D (range, —1 D to —11.25 D). In this study, high myopia was defined as a spherical equivalent of —D or less in either eye. A younger age at baseline predicted a higher prevalence of having high myopia. Researchers recommend that a generally accepted definition of high myopia be identified. The study appears in Acta Ophthalmologica .
  • Researchers evaluated the association between neodymium:YAG (Nd:YAG) capsulotomy and the risk of developing retinal detachment. Led by Andrzej Brzybowski, MD, researchers conducted a PubMed and Medline search using the terms "retinal detachment" and "Nd:YAG laser capsulotomy." Their literature analysis found no convincing evidence to support the association between Nd:YAG capsulotomy and an increased risk for retinal detachment. Researchers also did not find an association with preceding surgical approach, existing posterior vitreous detachment, and IOL design. However, they still advised that myopic patients be treated with caution, as it cannot be concluded that Nd:YAG capsulotomy does not increase their risk for retinal detachment. "Treatment energy should be as low as possible, as high energy levels and anterior hyaloid damage might increase the chance for [retinal detachment] development," they wrote. The study is published in the Asia-Pacific Journal of Ophthalmology .

Product News
  • MicroSurgical Technology (MST) released the MST 19-gauge Ahmed Micro Stent Cutter to offer a minimally invasive solution to trim stent protrusions.
  • Bausch + Lomb released the FreeFlow infusion system for retina surgery, which offers a higher level of infusion flow compared with previous generation infusion lines. The system supports vitreous removal provided by the Bi-Blade dual port vitrectomy cutters and Vitesse hypersonic vitrectomy system, both designed for use with the Stellaris Elite vision enhancement system.

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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