EyeWorld Weekly Update, February 9, 2018

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February 9, 2018
Volume 24 , Number 4

ReVision Optics goes out of business

ReVision Optics (Lake Forest, California), which had its Raindrop Near Vision Inlay approved by the U.S. Food and Drug Administration (FDA) in June 2016, has ceased business operations. "ReVision Optics ... made great strides to build a market for the surgical correction of presbyopia, but respectful of our best efforts, it is with regret, that we have to close our doors," the company announced on its website. The Raindrop Inlay is no longer available to practices or distributors. Questions can be answered by calling 866-934-6592; that number will be staffed through April 30, 2018.

FDA expedites review of AI diagnostic system for diabetic retinopathy

The U.S. FDA has given a "breakthrough device" designation to expedite the review of IDx-DR (IDx, Iowa City, Iowa), an artificial intelligence-based system created to detect diabetic retinopathy. IDx filed its de novo submission for IDx-DR earlier this week. The FDA's Breakthrough Devices Program is used for breakthrough technologies that can help with the diagnosis of life-threatening or irreversibly debilitating diseases, according to a company press release. The IDx-DR system analyzes retinal images and detects more than mild diabetic retinopathy in adults with diabetes who have not been previously diagnosed with the eye disease.

Phase 2b results announced for EGP-437 for post-cataract surgery pain and inflammation

Although EGP-437 (EyeGate Pharmaceuticals, Waltham, Massachusetts) had a higher rate of success compared with vehicle at all time points during a Phase 2b study, there was not a statistical significance with the co-primary endpoints of proportion of subjects with an anterior chamber cell count of zero at day 7 and the proportion of subjects with a pain score of 0 at day 1. EGP-437 is a combination product for post-cataract surgery pain and inflammation. The Phase 2b study was double masked, randomized, and vehicle controlled, and it enrolled 106 subjects at seven clinical sites across the U.S. The trial focused on safety and efficacy of transscleral iontophoretically delivered EGP-437 and dexamethasone through the EyeGate II Delivery System, used immediately after surgery. EGP-437 had a favorable safety profile with no serious adverse events. EyeGate leaders will continue to review the data and determine next steps with EGP-437, according to a company press release.

First patient enrolled in Phase 2b trial of reproxalap

The first patient has been enrolled in a Phase 2b trial for topical ocular reproxalap (Aldeyra Therapeutics, Lexington, Massachusetts) to treat dry eye disease. The company announced positive results from a Phase 2a clinical trial for reproxalap in September. Results from the trial are expected in the second half of this year, according to a company press release. The trial will evaluate two topical reproxalap concentrations (0.1% and 0.25%) against vehicle over 12 weeks in 300 patients with moderate dry eye. Endpoints will include standard signs and symptoms of dry eye. "Reproxalap and other product candidates generated from Aldeyra's aldehyde trap platform sequester and facilitate the degradation of pro-inflammation aldehyde mediators, a class of small molecule therapeutic targets that are elevated in dry eye disease patients," according to a company press release.

ASCRS Telemedicine in Refractive Surgery webinar on Wednesday, Feb. 21

Register now for the upcoming webinar "Telemedicine in Refractive Surgery,"which will take place on Wednesday, Feb. 21 at 9:00 p.m. EST. Sponsored by the ASCRS Refractive Surgery Clinical Committee, the webinar will discuss what it takes to build a teleophthalmology solution for your cataract and refractive surgery patients. You will also learn what the future looks like for telemedicine in ophthalmology and hear about the use of the remote control (drone) slit lamp for telemedicine consultations. Join speakers Roger Zaldivar, MD, Ranya Habash, MD, and Giselle Ricur, MD, for this dynamic learning experience. The cost to attend the webinar is $75 for nonmembers, or become a member of ASCRS today to access this event at no cost.

RESEARCH BRIEFS

  • Vision loss due to cataract and refractive error continues to cause the largest number of blindness cases and moderate or severe vision impairment in adults age 50 or older, according to a systematic review and meta-analysis led by Seth Flaxman, PhD, and co-researchers. Their review focused on vision loss data from 1990 to 2015 and included forecasts to 2020. Researchers evaluated relevant published and unpublished population-based data from 1980 to 2014 and identified 288 studies with 3.98 million participants from 98 countries. Uncorrected refractive error, cataract, age-related macular degeneration (AMD), glaucoma, and diabetic retinopathy were the leading causes, in respective order, of moderate or severe vision impairment in 2015. The leading causes of blindness were cataract, uncorrected refractive error, and glaucoma. Cataract and uncorrected refractive error combined contributed to 55% of blindness and 77% of vision impairment in adults age 50+. Blindness or vision impairment from diabetic retinopathy was more common in women, while men were more likely to have blindness or vision impairment due to glaucoma and corneal opacity. There was no sex difference related to AMD. The study appears in The Lancet Global Health.
  • A study from Joslin Diabetes Center, Boston, found that the absence of proliferative diabetic retinopathy in people with type 1 diabetes and chronic kidney disease was associated with a lower prevalence of cardiovascular disease, according to D. Gordin and co-researchers. The Joslin 50-Year Medalist cross-sectional study focused on individuals (n=762) with type 1 diabetes for 50 years or more. A replication cohort from the longitudinal Finnish Diabetic Nephropathy Study (n=675) was also used. Proliferative diabetic retinopathy status was independently associated with cardiovascular disease (odds ratio 0.21 [95% CI 0.08-0.58], P=0.003) in patients who also had chronic kidney disease. The study appears in Diabetes Care.
  • The use of two different riboflavin dosing regimens produced an equivalent reduction in maximum keratometry value and a favorable safety profile, according to Marianne Price, PhD, and co-researchers. Their prospective, randomized, single-center equivalence trial included 510 patients with progressive keratoconus or ectasia after refractive surgery. One eye for each patient was prospectively randomized to receive 2- or 5-minute riboflavin dosing intervals with standard corneal crosslinking, which included epithelial removal and 30-minute irradiation with 3mW/cm2 ultraviolet A light. The 2 one-sided test was used to assess treatment equivalence. Fellow eyes (n=207) were treated with 5-minute dosing and considered in the safety analysis. The mean reduction in maximum keratometry from baseline was equivalent with 2- and 5-minute riboflavin dosing intervals at 6 months. With both dosing intervals, there was a mean corrected distance visual acuity (CDVA) improvement of 0.07 logMAR. The study appears in Ophthalmology.
  • Femtosecond laser-assisted cataract surgery (FLACS) visual and refractive outcomes were favorable compared with manual phacoemulsification in a prospective multicenter case series that included 18 cataract surgery clinics in nine European countries and Australia, according to Mats Lundström, MD, and co-researchers. Data from consecutive eyes (3,379 cases) that had FLACS were entered in the European Registry of Quality Outcomes for Cataract and Refractive Surgery. The mean postop corrected distance visual acuity was 0.04 ± 0.15 logMAR. Postoperative complications occurred in 3.3% of patients, and surgical complications were reported in 2.9% of all cases. The best visual and refractive outcomes were reported in patients with good preop CDVA. However, all preop CDVA groups had acceptable outcomes, the authors concluded. The research is published in the Journal of Cataract & Refractive Surgery.

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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