EyeWorld Weekly Update, December 22, 2017

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December 22, 2017
Volume 23 , Number 44

Netarsudil ophthalmic solution approved by the FDA for elevated IOP

The U.S. Food and Drug Administration (FDA) has approved netarsudil ophthalmic solution 0.02% (Rhopressa, Aerie Pharmaceuticals, Irvine, California) to lower IOP in patients with open-angle glaucoma or ocular hypertension. The FDA approval took place 2 months in advance of the scheduled Prescription Drug User Fee Act goal date of Feb. 28, 2018, according to a company press release. Rhopressa is to be used once daily. Aerie plans to hire a sales force of 100 representatives in the first quarter of 2018 and launch the agent by mid-second quarter 2018, the company reported.

Voretigene neparvovec-rzyl gene therapy for rare retinal dystrophy approved by the FDA

Voretigene neparvovec-rzyl (Luxturna, Spark Therapeutics, Philadelphia) has been approved by the U.S. FDA to treat patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. It is a one-time gene therapy to be used only with patients with mutations on both copies of the RPE65 gene who have sufficient viable retinal cells as determined by the treating physicians, according to a company press release. Voretigene neparvovec-rzyl is the first gene therapy for a genetic disease approved by the FDA and the first pharmacologic treatment for an inherited retinal disease, according to the company. It is also the first adeno-associated virus vector gene therapy approved in the U.S. The gene therapy will be administered by retinal surgeons at selected treatment centers; the treatment is expected to be available at these centers in late first quarter 2018, the company reported.

U.S. patent awarded for iontophoretic delivery of corticosteroids to the eye

EyeGate Pharmaceuticals (Waltham, Massachusetts) has been awarded a patent by the U.S. Patent and Trademark Office titled "Delivery of corticosteroids through iontophoresis," the company announced. The patent covers the iontophoretic delivery of a dexamethasone phosphate formulation to a subject's eye to treat conditions such as postoperative inflammation and uveitis. EGP-437, the company's product candidate, iontophoretically delivers dexamethasone phosphate and is currently in a Phase 3 study for uveitis and a Phase 2b study to treat pain and inflammation after cataract surgery. For both indications, EGP-437 has been licensed to a subsidiary of Valeant Pharmaceuticals (Laval, Quebec).

Ocugen obtains license to develop products for inherited retinal disorders

Ocugen (Malvern, Pennsylvania) has obtained an exclusive worldwide license for the development and commercialization of ophthalmology products focused on inherited retinal disorders and developed by the Schepens Eye Research Institute, Massachusetts Eye and Ear Infirmary, Boston. The modifier gene therapy platform that Ocugen will develop could help restore retinal integrity and function across various genetically diverse inherited retinal disorders and other degenerative retinal diseases, according to a company press release. The technology encompasses targeted delivery and expression of nuclear hormone receptors expressed in retina tissue and identified by their ability to modify disease progression, according to the company. This approach may help with rare and orphan inherited retinal disorders such as S-cone syndrome, Goldmann-Favre syndrome, and retinitis pigmentosa.

RESEARCH BRIEFS

  • A review of participants in the National Health and Nutrition Examination Survey (NHANES) found that those who drank hot tea every day were less likely to have glaucoma than those who did not, according to Connie Wu and co-researchers. They evaluated the association between coffee, tea, and soft drink consumption and glaucoma among participants in the 2005-2006 NHANES via a retrospective cross-sectional study. Among 1,678 survey participants, glaucoma prevalence was 5.1%. Researchers found no statistically significant association between caffeinated and decaffeinated coffee, iced tea, and soft drinks and glaucoma. However, those who had at least one cup of hot tea every day had a 74% lowered odds of having glaucoma compared with those who did not drink hot tea. The researchers did not find a significant association between decaffeinated hot tea and glaucoma. Larger prospective studies are needed, the researchers concluded. The study appears in the British Journal of Ophthalmology.
  • A deep learning system that uses artificial intelligence had high sensitivity and specificity to detect diabetic retinopathy and related eye diseases compared with human graders, according to Daniel Shu Wei Ting, MD. The deep learning system in the study was evaluated using 494,611 retinal images; the deep learning system was trained to detect diabetic retinopathy, possible glaucoma, and age-related macular degeneration (AMD). The prevalence of referable diabetic retinopathy was 3%; vision-threatening diabetic retinopathy, 0.6%; possible glaucoma, 0.1%; and AMD, 2.5%. Sensitivity and specificity for the deep learning system for each disease was as follows: 90.5% and 91.6% for referable diabetic retinopathy; 100% and 91.1% for vision-threatening diabetic retinopathy; 96.4% and 87.2% for possible glaucoma; and 93.2% and 88.7% for AMD. The research appears in JAMA Ophthalmology.
  • Art observation training helped improve clinical ophthalmology observational skills in first-year medical students, according to a randomized, single-masked controlled trial led by Jaclyn Gurwin, MD. Researchers pursued this area of study because observation and description are crucial parts to the practice of medicine and especially within ophthalmology; however, there is no formal medical education in these areas, the study researchers reported. They randomized 36 first-year medical students 1:1 into art training and control groups. Those in the art training group were taught by professional art educators at the Philadelphia Museum of Art via six tailored 1.5-hour art observation sessions over 3 months. Subjects completed pre- and post-tests describing works of art, retinal pathology images, and eye disease photos. The main outcome measure was a written description for observational and descriptive abilities by reviewers using a rubric and masked to group assignment and pre-/post-test status. Observational skills increased significantly in the art group (mean change, +19.1 points) compared with the control group (mean change, -13.5 points; P=0.001). Improvements in a variety of test subscores also occurred. Principles in the area of visual arts could be applied to medical training, the researchers concluded. The study appears in Ophthalmology.
  • The prevalence of TGF beta-induced gene corneal dystrophies among Chinese refractive surgery candidates is approximately 0.24%, according to a prospective case series. Yanzheng Song, MD, and fellow authors analyzed refractive surgery candidates from five eye hospitals/centers in China. Patients had slit lamp biomicroscopy and collection of a buccal swab as a source of DNA for screening of the TGF beta-induced gene and the five most common mutations associated with Reis-Bücklers corneal dystrophy, Thiel-Behnke corneal dystrophy, granular corneal dystrophy type 1, granular corneal dystrophy type 2, and lattice corneal dystrophy type 1. Among the 2,068 refractive surgery candidates, four had corneal opacities on both eyes. Screening found the heterozygous p.R124H mutation associated with granular corneal dystrophy type 2 in each of the four candidates and in a fifth person without corneal opacities. A dystrophic corneal deposition developed after laser refractive surgery in two candidates who did not have preop gene screening. Genetic testing can help identify and exclude individuals with a gene dystrophy before elective refractive surgery, the authors concluded. The study appears in the Journal of Cataract & Refractive Surgery.
PRODUCT NEWS
  • Bausch + Lomb (Bridgewater, New Jersey) has begun distributing latanoprostene bunod ophthalmic solution 0.024% (Vyzulta) to U.S. wholesale pharmaceutical distributors.

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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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