EW Weekly, March 1, 2019

March 1, 2019
Volume 24 , Number 8

FDA approves LOTEMAX SM for postop inflammation, pain

The U.S. FDA has approved LOTEMAX SM (loteprednol etabonate ophthalmic gel, Bausch + Lomb) 0.38% to treat postoperative inflammation and pain after eye surgery. Compared with LOTEMAX GEL 0.5%, LOTEMAX SM has a submicron particle size for faster drug dissolution in tears, according to a company press release. LOTEMAX SM also has two times greater penetration to the aqueous humor compared to LOTEMAX GEL, according to the company. Approval of LOTEMAX SM was based on data from two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies in 742 patients with postop inflammation after cataract surgery. The use of LOTEMAX SM three times a day beginning the day after surgery was significantly more effective than vehicle. Also, twice as many patients had completely resolved inflammation with the use of LOTEMAX SM. The newly approved product should be available to patients by April.

NIH and NEI award grant to LumiThera for trial related to dry AMD

LumiThera will receive $2.5 million from the National Institute of Health (NIH) and the National Eye Institute (NEI) as part of the Small Business Innovation Research Phase 2 grant. The grant will support a prospective, randomized, multicenter human clinical trial in U.S. subjects diagnosed with dry AMD. Called LIGHTSITE III, the trial will test vision and analyze disease pathology in the eye after photobiomodulation treatments with LumiThera's Valeda Light Delivery System. The trial is subject to FDA Investigational Device Exemption approval. The company already has a CE mark to commercialize its light system in Europe for dry AMD.

Confirmatory results announced from second Phase 3 registration study for mydriasis agent

Positive results were announced from a second MicroStat (Eyenovia) Phase 3 study called MIST-2, according to a company press release. The study focused on safety and efficacy of Eyenovia's first-in-class fixed-combination formulation. The multicenter, randomized, double-masked superiority MIST-2 study included 70 subjects who were treated on separate days with Eyenovia's MicroStat fixed combination formulation of phenylephrine 2.5% and tropicamide 1%. The formulation was compared against a placebo solution; both were administered with the company's Optejet dispenser. When analyzing mean pupil dilation at 35 minutes, there was a treatment group difference of 4.6 mm, which showed that MicroStat was clinically and statistically superior, according to the press release. Ninety-three percent of eyes in the MicroStat group had 6 mm or greater pupil dilation, and 68% of eyes had 7 mm or greater pupil dilation. The eyes in the placebo group did not achieve similar results.

Roche to acquire Spark Therapeutics

Roche will acquire Spark Therapeutics under the terms of a definitive merger agreement. In addition to clinical assets for gene therapy hemophilia A and hemophilia B, Spark was the first company to receive FDA approval for a gene therapy for a genetic disease in 2017 with its product LUXTURNA (voretigene neparvovec-rzyl), indicated to treat patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy, which is currently marketed in the U.S.

Research briefs

  • Several months after cataract surgery, persistent tear instability and corneal epitheliopathy occurred in a group of patients. Led by A. Hanyuda, the study included 172 patients with bilateral cataract surgery and 1,225 controls with no cataracts who were evaluated for their subjective dry eye symptoms. Patients in the group with previous cataract surgery had cataract surgery at least 5 months before the study recruitment date. The subjective symptoms were generally inversely associated with cataract surgery. Pseudophakic patients had a 57% increased prevalence of severe keratoconjunctivitis (P= 0.02). Significantly lower odds of sensitivity to bright light were detected among the patients compared with the controls. The research demonstrates the importance of evaluating ocular surface conditions in pseudophakic patients, the authors concluded. The research is published in the Journal of Clinical Medicine.
  • There is a substantially greater potential productivity loss associated with visual impairment and blindness resulting from uncorrected myopia compared with the cost of myopia correction, reported Kovin Naidoo, PhD, and coresearchers in their systematic review and meta-analysis. Their review estimated loss from uncorrected myopia and myopic macular generation in 2015. Those with myopia were less likely to have adequate optical correction if they were older or lived in rural areas of less developed countries, the researchers wrote. There was a $244 billion global potential productivity loss associated with the burden of vision impairment from uncorrected myopia and $6 billion from myopic macular degeneration. Southeast Asia, South Asia, and East Asia bore the greatest potential burden as a proportion of their economic activity; East Asia had the greatest potential burden in absolute terms. The study appears in Ophthalmology.
  • Patient compliance with follow-up after cataract surgery was more likely to occur in those who were female, younger than 70 years, paying for their own surgery, and if they had phacoemulsification instead of manual small incision cataract surgery (P<0.001 for all), according to Sachin Gupta, PhD, and coresearchers, in their hospital-based retrospective cohort study. Researchers analyzed data from 86,776 cataract surgeries at one hospital in India; all patients were asked to return for follow-up after 1 month. The study compared follow-up rates between patients with different demographic characteristics, surgical factors, and preop and discharge visual acuity. The overall follow-up rate was 85.6%. Patients who had complications, reoperations, or poorer visual acuity at discharge were less likely to follow up (P<0.001). Targeted interventions to boost follow-up should be aimed at patients with characteristics found in the study, the authors concluded. The research appears in the Journal of Cataract & Refractive Surgery.
  • Severe iris damage is associated with a rapid reduction in endothelial cell density and graft endothelial failure after penetrating keratoplasty (PKP), reported Osama Ibrahim, MD, and coresearchers. Their prospective consecutive study included 74 patients who had PKP without graft rejection during the follow-up. Endothelial cell density was measured with specular microscopy at 1, 3, 6, and 12 months after PKP. Slit lamp microscopy or anterior segment OCT imaging was used to determine iris damage scores. Graft endothelial cell density decreased from 2674 ± 329 cells/mm2 to 2114 ± 570 at 1 month, 1907 ± 629 at 3 months, 1669 ± 738 at 6 months, and 1404 ± 792 at 12 months (P<0.0001 for all). Endothelial cell density at 12 months was associated with iris damage scores, graft endothelial cell density, and history of graft failure. The iris damage score also significantly correlated with the percentage of endothelial cell density loss at 1, 3, 6, and 12 months. In eyes with severe iris damage, graft survival rates were significantly lower than in eyes with no or mild iris damage (P<0.0001). The study is published in Cornea.

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.

For sponsorship opportunities or membership information, contact:

ASCRS•ASOA • 4000 Legato Rd. • Suite 700 • Fairfax, VA 22033 • Phone: 703-591-2220 • Fax: 703-591-0614 • Email: ASCRS

Opinions expressed in EyeWorld Weekly Update do not necessarily reflect those of ASCRS•ASOA. Mention of products or services does not constitute an endorsement by ASCRS•ASOA.

Click here to view our Legal Notice.

Copyright 2021, EyeWorld News Service, a division of ASCRS Media. All rights reserved.