EW Weekly, October 25, 2019

XEN 45 voluntary recall
Allergan initiated a voluntary recall of its XEN 45 glaucoma drainage device after its inspection process identified trace amounts of polishing compounds on a small number of units from an unreleased lot. The polishing compounds are used in the needle sleeve manufacturing process. Allergan has alerted regulatory agencies. Physicians are encouraged to continue routine postoperative follow up and report any adverse events to Allergan Product Surveillance at 1(800)433-8871. Read the full alert, which was issued in collaboration with ASCRS, here.

Bausch Health affiliate acquires license for commercialization of XIPERE
An affiliate of Bausch Health has acquired an exclusive license for the commercialization and development of XIPERE (triamcinolone acetonide suprachoroidal injectable suspension, Clearside Biomedical) in the U.S. and Canada, according to a press release from the two companies. XIPERE is designed to target macular edema associated with uveitis and formulated for suprachoroidal administration via Clearside's SCS Microinjector. The New Drug Application for XIPERE is slated to be resubmitted to the U.S. FDA in the first quarter of next year. The FDA will review the New Drug Application within 6 months of receipt of the resubmission, according to the press release.

Enrollment complete for Phase 2 trial of AR-1105
Aerie Pharmaceuticals announced completion of enrollment for its Phase 2 clinical trial of AR-1105, a treatment for macular edema due to retinal vein occlusion. According to the company, AR-1105 is a sustained-release, bioerodible intravitreal dexamethasone implant. The Phase 2 study is taking place at 19 U.S. centers and will include up to 49 patients (target 45). The trial will evaluate two formulations of AR-1105 to assess different durations of dexamethasone release. According to an Aerie news release, the primary objectives are safety, tolerability, and efficacy.

Study: Secondhand smoke exposure associated with choroidal thinning in children
In a cross-sectional study of 1,400 children in Hong Kong, secondhand smoke exposure in children was associated with choroidal thinning, reported Nan Yuan, MPhil, and coresearchers. Their study, published in JAMA Ophthalmology, focused on children age 6 to 8 years old who were consecutively recruited from the population-based Hong Kong Children Eye Study. All patients had detailed ophthalmic exams and choroidal thickness measured by swept-source OCT. A history of secondhand smoking was obtained from a questionnaire. Among the 1,400 children included, 67.2% had no secondhand smoke exposure. The mean age was 7.65 years for nonexposure group children and 7.54 years in the exposure group. After adjusting for age, sex, body mass index, axial length, and birth weight, exposure to secondhand smoke was associated with a thinner choroid by 8.3 µm in the central subfield, 7.2 µm on the inner inferior, 6.4 µm in the outer inferior, 6.4 µm in the inner temporal, and 7.3 µm in the outer temporal. An increase of one family smoker also was associated with choroidal thinning.

Submit your nomination for the inaugural ASCRS Educator Award
The new ASCRS Educator Award recognizes an ASCRS member who has made education an enduring career priority. Nominees must: have demonstrated passion and commitment to education, leadership, and selflessness in the pursuit of expanding knowledge in the interest of improving patient outcomes; be an ophthalmologist focused on anterior segment surgery; have at least 5 years in practice; and be a current ASCRS member.
Nominations are due by November 29. Find more information at ascrs.org/educatoraward.

Research briefs
  • More significant IOP reduction occurred at 12 weeks in eyes treated with steroid or nonsteroidal anti-inflammatory (NSAID) drops after selective laser trabeculoplasty (SLT) compared with ones that did not receive these drops, according to Sylvia Groth, MD, and coresearchers. The double-masked, randomized, placebo-controlled trial included adult patients with an IOP of more than 18 mm Hg who were to have SLT. Patients were randomized to one of three groups 1:1:1 as follows: ketorolac 0.5%, prednisolone 1%, or saline tears. Patients were instructed after surgery to use an unmarked drop four times a day, starting the day of SLT and continuing for 4 additional days. The primary outcome was the IOP at 12 weeks. Among the 96 eyes of 85 patients, both the NSAID and steroid drop groups showed a statistically significant greater decrease in IOP at week 12 compared with the placebo group (mean –6.2 mm Hg, –5.2 mm Hg, and –3 mm Hg, respectively). Short-term postop use of NSAID or steroid drops may improve IOP reduction after SLT, but longer follow-up studies are needed, the researchers concluded. The study appears in Ophthalmology.
  • Crosslinking (CXL) with intrastromal corneal ring segments (ICR) may be more effective for keratoconic eyes with more irregular astigmatism and worse corrected distance visual acuity (CDVA) compared with CXL alone, according to Neera Singal, MD, and coresearchers. The prospective, nonrandomized, interventional study compared CXL alone, CXL with simultaneous ICR, and simultaneous topography-guided PRK in progressive keratoconus, pellucid marginal degeneration, or LASIK-induced ectasia in a total of 452 eyes from 375 subjects. The change in logMAR uncorrected distance visual acuity was significant with CXL-ICR and CXL-topography-guided PRK but not with CXL alone. There were no significant differences in changes found among the three groups. The change in CDVA was significant in all three groups and was –0.12, –0.23, and –0.17 in CXL alone, CXL-ICR, and CXL-topography-guided PRK. Improvement in CDVA was greater with CXL-ICR than CXL alone. The research is published in the Journal of Cataract & Refractive Surgery.
  • The rate of filled opioid prescriptions for all kinds of incisional ocular surgery have increased over time despite widespread opioid abuse problems, reported Anton Kolomeyer, MD, PhD, and coresearchers. Their cohort study queried a large national U.S. insurer’s claims database, focusing on incisional ocular surgeries from January 2000 to December 2016. Eligible opioid prescriptions from 1 day before surgery to 7 days postoperatively were included. The study’s primary analysis focused on the rate of filled opioid prescriptions for each ophthalmic surgical specialty over time. Among 2.4 million incisional ocular surgeries, 1.90% were associated with an opioid prescription. The lowest rate of filled opioid prescriptions ocurred in the 2000 to 2001 cohort year (1.24%) and the highest in 2014 (2.51%). The year of surgery was significantly associated with filling an opioid prescription, with the highest odds in 2014 and the lowest odds in 2016. With the ongoing national opioid epidemic, understanding patterns of use can help to reverse the epidemic, the researchers concluded. The study appears in JAMA Ophthalmology.
  • Use of the CASIA2 anterior segment OCT (Tomey), the CASIA SS-1000 (Tomey), ultrasonography, and Scheimpflug camera all yielded similar results when performing anterior ocular biometric measurements in patients with cataract, according to Shinichi Fukuda, PhD, and coresearchers. Their study included 185 eyes of 128 participants with mild refractive error or cataract. Central corneal thickness (CCT), aqueous depth, and lens thickness were measured, and repeatability of the CASIA2 measurements was assessed. The CCT, aqueous depth, lens thickness and lens anterior curvature by CASIA2 showed high intraclass correlation coefficients of > 0.99. Measurements of the posterior part of the lens showed lower intraclass correlation coefficients. However, the intraclass correlation coefficients tended to be lower in mild cataracts compared with dense ones. No statistically significant difference was seen in the CCT and aqueous depth between the CASIA2 and CASIA SS-1000 or in the lens thickness measurements between the CASIA2 and AL-4000 (Tomey) and between the CASIA2 and Scheimpflug camera analysis. The study is published in Graefe’s Archive for Clinical and Experimental Ophthalmology.

This issue of EyeWorld Weekly was edited by Stacy Jablonski and Vanessa Caceres.

EyeWorld Weekly (ISSN 1089-0319), a digital publication of the American Society of Cataract and Refractive Surgery (ASCRS), 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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