EyeWorld Weekly Update, June 22, 2018

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June 22, 2018
Volume 24 , Number 22

Phase 3 results announced for Bimatoprost SR implant

Among 594 subjects with open angle glaucoma or ocular hypertension in a Phase 3 study, Bimatoprost Sustained-Release (Bimatoprost SR, Allergan, Dublin, Ireland) lowered IOP by about 30% over a 12-week primary efficacy period, according to a company press release. This met predefined criteria for noninferiority to timolol. Initial data showed the potential for most of the patients to remain treatment-free for 1 year after the last implant was inserted. The implant was well tolerated in most patients. In the multicenter, randomized study, the efficacy and safety of two dose strengths of Bimatoprost SR were compared to timolol eye drops used twice a day for up to 20 months. Patients are randomized in the study to receive three administration cycles of Bimatoprost SR at day 1, week 16, and week 32 or twice-a-day timolol drops in study eyes. There will be additional data reported in the first half of 2019 from a second Phase 3 study. Allergan expects to file a New Drug Application with the U.S. Food and Drug Administration (FDA) in the second half of 2019 for the implant. Bimatoprost SR is geared toward lowering IOP for at least 4 months, according to the company.

First patient enrolled in pivotal Phase 3 epi-on corneal crosslinking trial for keratoconus

The first patient has been enrolled in a Phase 3 trial to evaluate the safety and efficacy of ACP-KXL-308 (Avedro, Waltham, Massachusetts), an epithelium-on corneal collagen crosslinking (CXL) procedure for patients with progressive keratoconus. The multicenter, randomized, controlled study includes 275 patients at about 20 sites across the U.S., according to a company press release. Study sites are located in Massachusetts, Ohio, Utah, Pennsylvania, and Virginia.

First patient enrolled in Phase 1/2 study for platelet lysate biologic for graft-versus-host disease

The first patient has been enrolled in a Phase 1/2 randomized, multicenter, double-masked, placebo-controlled parallel study of Elate Ocular topical fibrinogen-depleted human platelet lysate biologic (Cambium Medical Technologies, Atlanta) for patients with dry eye secondary to graft-versus-host disease. The core study involves at least 60 patients at up to five eye centers in the U.S.; including two sub-studies, there will be a total of 108 patients, the company reported in a press release. Although autologous and platelet rich plasma serum are generally proven therapies to treat dry eye and cornea diseases and conditions, their use has been largely relegated to end stage, according to Cambium president and CEO Terence Walts. The company thinks its therapy has potential as a main stage, first-line therapy.

2018 Combined Ophthalmic Symposium program preview now online

Have you registered for the 2018 Combined Ophthalmic Symposium? The comprehensive program preview is now online. Get a glimpse of the valuable and engaging education available to you and your staff. The Combined Ophthalmic Symposium provides education for an entire ophthalmic practice in one weekend and offers opportunities for staff development through educational tracks for ophthalmologists, optometrists, practice management staff, and nurses and technicians. There is also a specialized track designed for residents and fellows. In addition to the exceptional education, the Combined Ophthalmic Symposium hosts a world-class Exhibit Hall featuring industry exhibitors representing a variety of products and services. All attendees are invited to the Welcome Reception, which will be held on Friday, August 24 in the Exhibit Hall beginning at 5:30 p.m.

RESEARCH BRIEFS

  • When assessing the ability of air puff-derived biomechanical variables to predict surgeon-perceived candidacy for LASIK, Vinicius De Stefano, MD, and fellow researchers found the hysteresis loop area was predictive of which patients were disqualified for LASIK. The retrospective case series included data collected from refractive surgery screening examinations by two surgeons at two centers. The 47 total eyes that were disqualified were judged not to be candidates based on available data, including standard variables from the Ocular Response Analyzer (Reichert Technologies, Depew, New York). There was also a control group of 26 and 23 LASIK candidates from each surgeon. The hysteresis loop area was significantly different between disqualified cases and controls for both surgeons. The hysteresis loop area also had the highest odds ratio (Surgeon 1, 4.48; Surgeon 2, 20.00). The adjusted R2in best-subsets regressions were 40.2% and 62.9% for Surgeon 1 and Surgeon 2, respectively. "Certain measures of the corneal dynamic response to an air puff might serve as correlates to clinically perceived ectasia risk," the researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.
  • Patients with both cataracts and wet age-related macular degeneration can safely have cataract surgery, concluded Matthew Starr, MD, and fellow researchers, in their retrospective cohort study to investigate whether having macular fluid on OCT before cataract surgery adversely affected vision or anatomic outcomes after cataract surgery. All patients (n=81 eyes) who had cataract surgery and were receiving intravitreal antivascular endothelial growth factor injections between 2012 and 2016 were included. Data collected included the development of subretinal or intraretinal macular fluid or subretinal hemorrhage in the 6-month postoperative period, number of injections, best corrected visual acuity (BCVA), and central subfield thickness. A significant improvement between preop and postop BCVA was seen when comparing all patients (P<.0001); there was no significant difference in central subfield thickness before and after surgery. With preop OCT, there were 23 eyes with fluid. No differences in final BCVA or central subfield thickness were found.Patients also saw a significant improvement in BCVA. The study appears in the American Journal of Ophthalmology.
  • Twenty-four hour recordings with the use of a contact lens sensor could help with risk stratification in patients with treated glaucoma, according to a cohort study with 445 eyes that was led by Carlos Gustavo De Moraes, MD. The multicenter retrospective study took place at 50 ophthalmology centers in 13 countries and included patients with treated, manifest open angle glaucoma. The 24-hour records of IOP-related patterns were prospectively collected. After adjustment for baseline mean deviation severity, age, and treatment, variables associated with fast visual field progression included mean peak ratio while awake, number of long peaks during sleep, night bursts ocular pulse frequency, and night bursts ocular pulse amplitude SD. When testing the association with rates of progression, regression models including contact lens sensors had better fit than Goldmann IOL measurements taken at follow-up. The use of contact lens sensors may be helpful when sufficient historical visual field information is not available, the authors concluded. The study appears in JAMA Ophthalmology.
Product news
  • The U.S. FDA has approved the iDesign Refractive Studio (Johnson & Johnson Vision, Santa Ana, California). The system is approved for myopia, hyperopia, and mixed astigmatism and uses topography-integrated, wavefront-guided technology.
  • Bausch + Lomb (Bridgewater, New Jersey) has received premarket approval from the U.S. FDA for its enVista toric MX60T, the company's first hydrophobic acrylic IOL for astigmatism correction.
  • LacryDiag (Quantel Medical, Clermont-Ferrand, France) was launched earlier this month as an ocular surface analyzer that is CE marked and is approved by the U.S. FDA.

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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