EyeWorld Weekly Update, June 8, 2018

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June 8, 2018
Volume 24 , Number 20

First patient enrolled in trifocal IOL trial

The first patient has been enrolled in a trial focused on the efficacy and safety of the enVista MX60EF (Bausch + Lomb, Bridgewater, New Jersey), a trifocal IOL. The study supports a Pre-Market Approval application filing with the U.S. Food and Drug Administration, according to a company press release. The multicenter, randomized study will include 500+ subjects who will have bilateral cataract surgery and receive the MX60EF or the MX60E, the latter of which is a monofocal IOL. Based on post-surgical observation, investigators will determine efficacy endpoints after 6 months and safety endpoints after 12 months. The enVista MX60EF is a single-piece, ultraviolet-absorbing posterior chamber IOL.

Results announced from Phase 2 trial of CLS-TA used with aflibercept for DME

Positive topline results were announced from a Phase 2 clinical trial evaluating suprachoroidal CLS-TA (Clearside Biomedical, Alpharetta, Georgia) used with aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) in patients with diabetic macular edema (DME). The trial, called TYBEE, met its primary endpoint of a mean improvement in best corrected visual acuity from baseline over 6 months as measured with the Early Treatment Diabetic Retinopathy Study (ETDRS) scale, according to a company press release. TYBEE enrolled 71 patients who were naïve to DME treatment and were randomized 1:1 to receive quarterly treatments with suprachoroidal CLS-TA along with intravitreal Eylea at months 0 and 3 or four monthly Eylea treatments and a sham suprachoroidal treatment at months 0, 1, 2, and 3. Patients in either arm received intravitreal Eylea at months 4 and 5 as needed. Patients in the combination group gained 12.3 ETDRS letters on average compared with 13.5 ETDRS letters in the Eylea control arm (P=0.664). The use of both suprachoroidal CLS-TA and intravitreal Eylea led to a mean reduction from baseline of 208 microns in central subfield thickness of the retina at 6 months compared with a 177-micron mean reduction in the control arm. No serious adverse events related to treatment were reported through the 24-week evaluation period. Suprachoroidal CLS-TA is a proprietary suspension of triamcinolone acetonide formulated for the suprachoroidal space.

ASCRS Foundation announces 3rd annual National Sight Week

June is National Cataract Awareness Month. In recognition, the ASCRS Foundation is pleased to announce that it will host its 3rd annual National Sight Week initiative, October 14-20. Operation Sight is the ASCRS Foundation's U.S.-based charitable cataract surgery program. It involves a nationwide network of ASCRS surgeons who provide care to those unable to access or afford cataract surgery on their own. Since its launch in late 2014, Operation Sight has delivered more than 2,100 free surgeries. This year the goal is to not only increase the number of charitable cataract surgeries delivered during National Sight Week but to raise overall awareness of the year-long Operation Sight program. The ASCRS Foundation provides participating practices with a $250 stipend for each charitable cataract case delivered as a way to lessen the cost burden associated with providing the surgery. There is no minimum number of cases required to participate; the goal is to increase the availability of charitable cataract surgery through access to volunteer surgeons nationwide. For more information on Operation Sight or National Sight Week, visit www.ascrsfoundation.org/nationalsightweek or contact Evelyn Morales at the ASCRS Foundation at emorales@ascrs.org or 703-591-2220.

RESEARCH BRIEFS

  • LASIK and PRK can be safety performed in selected patients taking isotretinoin, reported Julio Ortega-Usobiaga and coresearchers. Traditionally, isotretinoin has been contraindicated for these procedures. The multicenter, retrospective, interventional case series included 113 patients (219 eyes). Patients were divided into a group that took isotretinoin between 2003 and September 2017 and those who had taken it before but not in the previous 6 months. Researchers found no significant intraoperative or postoperative complications. There was no significant difference between groups relating to postop spherical equivalent, efficacy index, predictability, or safety index. When considering only PRK, the efficacy index, postop sphere, and postop astigmatism were better, but the difference was not clinically relevant. The research appears in the American Journal of Ophthalmology.
  • In a prospective case series that evaluated and compared postop pain after PRK and corneal crosslinking (CXL), the epithelial defect healing rate was significantly faster in the CXL group than in the PRK group. However, researchers, led by Siamak Zarei-Ghanavati, MD, found that the pain level was greater in the CXL group. The PRK group included patients with simple refractive errors; the CXL group included patients with clinical keratoconus. The pain level for participants from each group was compared with the visual analogue scale, verbal rating scale, and the Wong-Baker FACES pain scale immediately postop, and at 6 hours and 1, 3, and 7 days postop. Epithelial defect size was measured at 6 hours and at 1 and 3 days postop. A total of 68 patients were included, with 34 in each group. Pain was markedly higher after CXL based on the visual analogue and verbal rating scale; it was also higher using the FACES scaling system, but the difference was not statistically significant. The research is published in the Journal of Cataract & Refractive Surgery.
  • The risk of late age-related macular degeneration may be associated with at least 3 months' use of anticholinergic drugs, reported Gauthier Aldebert, MD, and coresearchers. The multicenter case-control study included 200 cases with late AMD and 200 controls enrolled between July 2016 and June 2017. There were 26 cases (13%) and 10 controls (5%) exposed to anticholinergic drugs throughout life for at least 3 months before AMD onset. The risk for AMD increased with every exposure to these drugs, a high Anticholinergic Burden Score, and longest cumulative exposure to anticholinergic drugs. Longitudinal studies could help to confirm this association, the researchers concluded. The study appears in JAMA Ophthalmology.
  • The use of IBI-10090 (Dexycu, Icon Bioscience, Newark, California), an anterior chamber intracameral dexamethasone drug delivery suspension used after cataract surgery, was safe and effective for treating inflammation, according to Eric Donnenfeld, MD, and Edward Holland, MD. Their prospective, randomized, double-masked trial included 394 participants randomized 1:2:2 to receive 5-microliter injections of placebo or 5-microliter injections of 342 or 517 micrograms of IBI-10090 in the anterior chamber at the end of cataract surgery. The primary outcome was anterior chamber cell clearing in the study eye at postop day 8. Anterior chamber cell clearing was complete at postop day 8 in 25% of eyes in the placebo group and 63.1% and 66% of eyes in the 342- and 517-microgram treatment groups, respectively (P<0.001). Adverse events among all three groups were similar; no serious ocular adverse events were reported up to postop day 90. The findings are reported in Ophthalmology.

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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