EW Weekly, February 8, 2019

February 8, 2019
Volume 24 , Number 5

FDA accepts IND application for study of drug that reduces myopia progression

The U.S. Food and Drug Administration (FDA) has accepted an Investigational New Drug (IND) application for a study of the drug MicroPine (Eyenovia, New York), which aims to reduce myopia, according to an Eyenovia press release. The Phase 3 registration trial, called CHAPERONE, will be a multicenter, randomized, double-masked trial that will include more than 400 children between 5 and 12 years old. Participants will be randomized to one of two MicroPine treatment concentrations or a placebo control arm. Trial enrollment is slated for the first half of this year.

Results announced for Phase 3 trial for dry eye treatment

Results from the Phase 3 HELIX trial, focused on the efficacy and safety of tivanisiran (Sylentis, Madrid, Spain) for dry eye, showed an improvement (P=0.035) compared with artificial tears in reducing corneal staining in moderate to severe dry eye after 1 month. There also was an improvement in ocular pain symptoms and signs of corneal staining. However, the primary endpoints of ocular pain and total corneal staining were not met. The trial also showed with tivanisiran use a 125% increase in mucin and a 13% decrease in the inflammation marker HLA-DR. There were no serious adverse events after 28 days of treatment. The data will be presented to the FDA and other regulatory authorities during the second quarter of 2019, according to a company press release.

Trial begins for acute adenoviral conjunctivitis treatment

A Phase 2 clinical trial called RUBY is underway for OKG-0301 (Okogen, San Diego), a topical ophthalmic formulation for acute adenoviral conjunctivitis. The treatment is a targeted ribonuclease with established broad-spectrum properties, according to a company press release. The multicenter, randomized, placebo-controlled, double-masked trial will evaluate multiple doses of the agent in 219 adult patients and assess the ability of the drug to reduce viral burden. Researchers also will evaluate the agent's safety and potential to lower long-term complications of adenoviral infection.

Study funded by NEI to compare NGoggle with traditional glaucoma detection

Research funded by the National Eye Institute (NEI) will test a wearable brain-based device called NGoggle, which incorporates virtual reality and could help improve glaucoma diagnosis, according to an NEI press release. The device has head-mounted virtual reality goggles that use light to stimulate targeted areas of a person's visual field and are integrated with wireless electroencephalography. In collaboration with Duke University, Durham, North Carolina, the study will validate the device's diagnostic accuracy and reproducibility and will compare NGoggle to standard automated perimetry. Study results will inform an application to the FDA to market the device, according to the press release.

Janssen, MeiraGTx enter a collaboration, license agreement for gene therapy program

Janssen Pharmaceutical Companies (Raritan, New Jersey) has begun a worldwide collaboration and license agreement with MeiraGTx (London) to develop, manufacture, and commercialize its clinical stage inherited retinal disease portfolio, which includes its product candidates for achromatopsia caused by mutations in CNGB3 or CNGA3 and X-linked retinitis pigmentosa.

Research briefs

  • A systematic review of randomized controlled trials comparing multifocal IOLs and standard IOLs found that multifocals led to better uncorrected near vision and a higher proportion of patients with spectacle independence. However, there was a greater risk of unwanted visual phenomena, reported Sumitra Khandelwal and coresearchers. Their review of research from 2006 to 2017 included 25 studies and found no difference in pooled estimates of corrected or uncorrected distance vision between multifocal and standard IOLs. However, there were better pooled results for the near vision outcome, spectacle dependence, and borderline significantly better quality of vision for multifocal IOLs. Multifocals had statistically significant worse pooled results for glare and halos. Newer multifocal IOLs had better outcomes than older diffractive lenses or refractive lenses. The study is published in Graefe's Archive for Clinical and Experimental Ophthalmology.
  • Risk of complications from cataract surgery among patients exposed to tamsulosin and those who were not exposed decreased between 2003 and 2013, reported Robert Campbell, MD, and coresearchers. Because of the association of tamsulosin with intraoperative floppy iris syndrome, researchers decided to conduct a population-based study to evaluate cataract surgical adverse event rates over time among patients. The study included all male patients age 66 or older and having cataract surgery in Ontario, Canada, from 2003 to 2013. Adverse events included posterior capsule rupture, dropped lens fragments, retinal detachment, and suspected endophthalmitis. The risk of surgical adverse events went down among both groups of patients (tamsulosin-exposed, odds ratio, 0.95 per year; 95% confidence interval, 0.91-0.99 per year; not exposed, 0.96 per year; 95% confidence interval, 0.95-0.98 per year). Despite the decrease, researchers recommend ongoing efforts continue to develop and disseminate surgical approaches that mitigate risks posed by tamsulosin. The study is published in Ophthalmology.
  • In a prospective, controlled clinical trial comparing two trifocal IOLs, both lenses led to significant improvements in visual acuity and gained functional uncorrected visual acuity across all distances, reported Francisco Poyales, MD, and coresearchers. Patients were implanted bilaterally with a trifocal spherical hydrophilic IOL (FineVision POD F, PhysIOL, Liège, Belgium) for corneal astigmatism of 1 D or less or with a trifocal toric hydrophilic IOL (FineVision POD FT) if there was more than 1 D of astigmatism. Three-month outcomes that were analyzed included monocular and binocular visual acuities at distance, near, and intermediate, both uncorrected and corrected. Although the distance visual acuities were good with both IOLs, distance-corrected near visual acuity was slightly better in the spherical IOL group. There was no difference in contrast sensitivity, defocus curves, cylinder, or patient satisfaction. The research appears in the Journal of Cataract & Refractive Surgery.
  • Patient punctuality improved in a study that asked patients to arrive 15 minutes before their actual appointment time, according to JC Cowdell and coresearchers. After learning that 39% of patients at an academic primary care center were not ready for evaluation by their scheduled appointment time, researchers aimed to reduce this to 20% in 3 months. A quality improvement team reformed the scheduling process to include a built-in 15-minute early arrival for acute visits for a 20-week trial period. After that, it was disseminated to all appointment types. Among the 182 patients during the 2-week trial, 19% were not ready at the time of their appointment, which was a 20% improvement. Among the 2,832 patients seen during the next 3 months, 21% were not ready on time. The approach could be a simple, inexpensive intervention to improve patient punctuality, the researchers concluded. The study is published in Quality Management in Health Care.
  • The Tecnis Eyhance IOL (Johnson & Johnson Vision, Santa Ana, California) launched in Europe.
  • Yutiq (fluocinolone acetonide intravitreal implant 0.18 mg, EyePoint Pharmaceuticals, Watertown, Massachusetts) launched commercially in the U.S. It is FDA-approved as a 3-year microinsert to treat chronic noninfectious uveitis.

This issue of EyeWorld Weekly Update was edited by Amy Goldenberg and Vanessa Caceres.

EyeWorld Weekly Update (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery and the American Society of Ophthalmic Administrators, 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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