EW Weekly, February 1, 2019

February 1, 2019
Volume 24 , Number 4

Phase 3 results announced for mydriasis agent

In its Phase 3, randomized, double-masked, superiority trial, the agent MicroStat (Eyenovia, New York) had a statistically and clinically superior mydriatic effect, according to a company press release. The study focused on the safety and efficacy of the company's first-in-class, fixed-combination formulation. In the trial, 64 subjects were treated on separate days with the company's phenylephrine 2.5%/tropicamide 1% agent. MicroStat was administered with the company's OpteJet technology, which is a smart microdose eyedropper-free delivery system. At 35 minutes post-administration, MicroStat was superior compared with each component formulation of tropicamide and phenylephrine. Also at 35 minutes, 94% of eyes had 6 mm or greater pupil dilation, compared with 78% and 1.6% for the tropicamide and phenylephrine-only groups, respectively.

FDA accepts NDA for blepharitis treatment NCX4251

The U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug application for NCX4251 (Nicox, Sophia Antipolis, France), according to a company press release. NCX4251 is an ophthalmic suspension of fluticasone propionate nanocrystals to treat the eyelid margin in patients with acute exacerbations of blepharitis. Nicox plans to announce the start of a first-in-human, randomized, placebo-controlled Phase 2 trial in blepharitis patients, with top-line results expected in the second half of this year. The drug is being developed for application via a swab at the eyelid margin that would be applied directly to the site of inflammation. Fluticasone propionate has not been approved before as a topical treatment in ophthalmology, according to the press release.

Preclinical trial of R:GEN laser for dry AMD begins

A preclinical trial to determine the optimal setting for the R:GEN laser (Lutronic Vision, Burlington, Massachusetts) has begun, according to a company press release. When the study ends, the company will be able to initiate clinical evaluation of the laser's ability to treat dry age-related macular degeneration. The laser platform targets the retinal pigmented epithelium to regenerate and restore its function, according to the company.

Topical diquafosol solution effective for dry eye, according to meta-analysis

In a review of nine qualified randomized controlled trials, topical diquafosol 3% (Diquas, Santen, Osaka, Japan) was found to be effective for treating dry eye, according to K. Nam and coresearchers. The trials included a total of 1,467 patients. There were statistically significant improvements in Schirmer test scores, fluorescein stain, rose bengal stain, and tear film breakup time after treatment compared with those using other eye drops. Randomized controlled trials with larger sample sizes and that focus on different types of dry eye disease could help determine the efficacy and limitations of diquafosol, the researchers wrote. The study is published in Ophthalmic Research.

U.S. task force: Provide prophylaxis in all newborns against gonococcal ophthalmia

The U.S. Preventive Services Task Force reiterated its previous conclusion that topical ocular prophylaxis is effective in preventing gonococcal ophthalmia neonatorum and related ocular conditions, according to an article published in JAMA. Gonococcal ophthalmia neonatorum can lead to corneal scarring, ocular perforation, and blindness at just 24 hours after birth. Without prophylaxis, transmission rates of infection from mother to newborn are 30% to 50%, the task force reported. In the U.S., there were an estimated 0.4 cases per 100,000 live births each year from 2013 to 2017, according to the report. The review of more recent evidence since their 2011 recommendation led the task force to reaffirm the previous conclusion that topical ocular prophylaxis of all newborns provides benefits.

Research Briefs

  • An investigational eye drop with 20 micrograms/ml of naltrexone (NTX) reversed tear film deficits and restored corneal surface sensitivity in rats with type 1 diabetes, according to Patricia McLaughlin and coresearchers. The diabetic rats received a single drop of NTX-001 or vehicle onto one eye twice a day for 30 days. For comparison, some of the rats received drops containing NTX in sterile Vigamox (moxifloxacin, Alcon, Fort Worth, Texas). Researchers measured tear production and ocular surface sensitivity. Within hours of a single treatment, dry eye was reversed; over 10 days, corneal sensitivity was restored, and dry eye was reversed compared with diabetic rats receiving vehicle. There were no toxic side effects. The study is published in BMC Ophthalmology.
  • Following femtosecond laser-assisted cataract surgery, IOP remained lower in eyes with glaucoma at 3 years after cataract surgery, following an initial rise at 1 day postop. Avni Shah, MD, and coresearchers conducted a retrospective case series and focused on the change in mean IOP from baseline to postop. There were 278 eyes in the glaucoma/glaucoma suspect group and 226 in the control group. An initial increase in IOP at 1 day postop was seen in both groups, with a significantly higher increase in the glaucoma/glaucoma suspect group. However, the IOP returned to baseline levels at 1 week. There was a significant decline in IOP in both groups at 1 month, which continued until year 1 in the control group and for 3 years in the glaucoma group. The glaucoma group had significantly greater IOP lowering than the control group after 6 months. During follow-up, the number of IOP medications used among those in the glaucoma/glaucoma suspect group remained unchanged. The study is published in the Journal of Cataract & Refractive Surgery.
  • A dome-shaped macula may be protective for visual function after cataract surgery in patients with high myopia, reported Xiangjia Zhu and coresearchers. Their study included 891 eyes (600 patients) analyzed by OCT through the central fovea. All patients had cataract surgery. A dome-shaped macular was defined as an inward bulge of more than 50 microns in horizontal or vertical OCT sections. The occurrence of maculopathies was compared between eyes that had or did not have a dome-shaped macula. Researchers also evaluated age, sex, eye laterality, and axial length. Nearly 14% of patients had a dome-shaped macula, the latter of which was associated with extrafoveal retinoschisis more than any other vision-threatening complications. In patients with bilateral high myopia, the occurrence of dome-shaped macula increased with the degree of anisometropia. It also was more common in the longer eyes of patients with anisometropia. Being younger, male, having a shorter axial length, and the presence of a dome-shaped macula all were associated with better postop visual acuity. The study is published in the British Journal of Ophthalmology.
  • A multicenter study focused on the feasibility, safety, and efficacy of allogeneic corneal epithelial stem cells to treat bilateral limbal stem cell deficiency reported positive results. John D.M. Campbell and coresearchers used cadaveric corneal tissue as an allogeneic source of transplantable cells. Patients were randomized to receive corneal epithelial stem cells that were cultured on amniotic membrane and included the investigational medicinal product or that were control amniotic membrane only. Of the 16 patients included, 13 completed all assessments. At the end of the trial, 9 of the 13 had improved visual acuity, with no significant differences between the investigational medicinal product and the control groups. There was a significant, sustained improvement in the ocular surface score in the investigational arm. Strongly elevated levels of CXCL8 were observed in the serum of patients with aniridia, which continued throughout the trial. The research is published in Stem Cells Translational Medicine.

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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