EyeWorld Weekly Update, May 11, 2018

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May 11, 2018
Volume 24 , Number 16

Shire and Takeda reach agreement for acquisition

Shire (Dublin, Ireland) and Takeda Pharmaceutical (Osaka, Japan) have reached an agreement on the terms of Takeda's acquisition of Shire, according to press releases from both companies. Shareholders from Shire will be entitled to receive $30.33 in cash for each Shire share and 0.839 new Takeda shares or 1.678 Takeda ADSs. The boards of directors from both companies have approved the transaction, which is expected to close in the first half of 2019. It will be the biggest acquisition by a Japanese company of a Western company and will create the world's eighth-largest drug maker by sales, according to the Wall Street Journal.

Phase 1 trial for bioresorbable travoprost implant completes treatment of first patient

Treatment of the first patient in a Phase 1, open-label, proof-of-concept clinical trial has taken place with OTX-TIC (Ocular Therapeutix, Bedford, Massachusetts). OTX-TIC is a bioresorbable travoprost implant delivered via an intracameral injection to reduce IOP in patients with primary open angle glaucoma and ocular hypertension. Its target duration is 4-6 months. Preclinical studies showed an acceptable safety profile and a marked reduction in IOP. The Phase 1 study will focus on the safety, efficacy, durability, and tolerability of OTX-TIC.

Preclinical findings for nanoemulsion formulation of brimonidine tartrate presented

Preclinical findings for a nanoemulsion formulation of brimonidine tartrate (OCU300, Ocugen, Malvern, Pennsylvania) found statistically significant efficacy of OCU300 in a surrogate mouse model of ocular graft-versus-host disease compared with placebo, untreated control, and marketed brimonidine. OCU300 is in Phase 3 clinical development to treat ocular graft-versus-host disease and is the only product to be granted Orphan Drug Designation for this indication from the U.S. Food and Drug Administration (FDA), a company press release reported. The Phase 3 trial is planned to begin this quarter. The results were presented at the 2018 Association for Research in Vision and Ophthalmology annual meeting.

Trial begins for new ophthalmic viscosurgical device

A clinical trial for a new ophthalmic viscosurgical device (OVD) from Bausch + Lomb (Bridgewater, New Jersey) has begun. The company plans to file for pre-market approval with the U.S. FDA when the trial is finished, with plans to bring it to the U.S. market in 2019.

Register now for the 2018 Young Eye Surgeons Advanced Cataract Training

Are you a resident, fellow, or surgeon in your first 5 years of practice? ASCRS has a program designed specifically for you, Young Eye Surgeons (YES) Advanced Cataract Training. Registration is now open for this year's event, September 15-16 in San Francisco. YES Advanced Cataract Training provides in-depth education and features hands-on wet labs, video case presentations, and roundtable discussions with leading experts.

RESEARCH BRIEFS

  • Risk factors related to poor refractive outcomes after cataract extraction included poor preoperative corrected distance visual acuity (CDVA), ocular comorbidity, and previous eye surgery, according to a multicenter database study involving 100 cataract surgery clinics from 12 European countries and led by Mats Lundstrom, MD. Researchers collected data on consecutive cataract extractions that were reported to the European Registry of Quality Outcomes for Cataract and Refractive Surgery during 2014 and 2015. Data were analyzed for demographics, preop CDVA, target refraction, coexisting eye diseases, surgical difficulties (including previous ophthalmic interventions), surgery type, IOLs, and surgical complications. Follow-up data were available for 282,811 of the 548,392 cases analyzed. When risk factors such as poor preop CDVA, ocular comorbidity, and previous eye surgery are present in patients, care should be taken with the preop exam and IOL choice to avoid a refractive surprise, researchers concluded. The study is published in the Journal of Cataract & Refractive Surgery.
  • Many U.S. ophthalmology residents experience burnout and depression, reported Elaine Tran, BS, and coresearchers in a national survey of 1,048 ophthalmology residents. The study's main outcomes included residents' reports regarding their personal experiences with wellness during residency, support systems provided by their programs, and opportunities to improve wellness. Among the respondents, 68.4% faced an issue with depression, burnout, or suicide within the past year; 26.3% reported that they were involved in a case when resident fatigue, burnout, or depression adversely affected a medical outcome. However, only 45.6% of respondents felt that their residency programs placed a moderate or major emphasis on promoting a culture of resident wellness. The biggest barrier to resident wellness was a lack of time to attend wellness programs. The study appears in JAMA Ophthalmology.
  • Among dry eye patients, women tend to have significantly higher symptom scores compared with men and a lower correlation between symptoms and signs. Led by J. Vehof, the cross-sectional study included 755 dry eye patients who had their symptoms assessed with the Ocular Surface Disease Index questionnaire and dry eye signs assessed with the six most commonly used tests. Patients were separated into groups based on overall sign severity; specific symptoms were compared by sex. There were higher total symptom scores in women versus men in both the mild (P=.01) and moderate (P<.005) signs groups, although the difference was less apparent in the severe signs group (P=.33). Women consistently reported more light sensitivity compared with men (P<.01 in all groups), and the correlation between symptoms and overall severity of signs score was markedly lower in women. The clearest differences between women and men were seen in the Schirmer and tear film break-up time tests. The study is published in Ocular Surface.
  • During ocular trauma, traumatic visual pathway injuries (VPIs) occurred in both major and minor ocular injuries-an important point as traumatic VPIs are frequently associated with severe head trauma and can have significant effects on development in children and can complicate rehabilitation, according to Ryan Gise, MD, and co-investigators. They retrospectively evaluated pediatric patients with VPI submitted to the National Trauma Data Base using ICD-9CM codes. Among 58,765 pediatric patients with ocular injuries, 1.7% had VPI. Most were male (69.2%), with a mean age of 11.6 years. The most common VPI was traumatic optic neuropathy (86.1%), which also had the greatest odds of occurring with oculomotor injury. Open adnexa wounds and orbital fractures were associated ocular injuries. Motor vehicle occupant and firearms were the most common causes. Overall mortality was 17.6%. Motor vehicle occupant injuries were more common in white patients; firearm injuries were more common in black patients and in the 19- to 21-year-old age group. Falls were the most common VPI among those age 0 to 3 years. The study appears in Pediatric Neurology.
PRODUCT NEWS
  • A European CE mark has been obtained for the Vivinex IOL (Hoya Surgical Optics, Singapore) with the new multiSert 4-in-1 preloaded delivery system.
  • Monaco (Optos, Dunfermline, Scotland), the first ultra-widefield imaging device combined with OCT, launched this month in the U.S. Monaco represents the company's first combined imaging device with ultra-widefield color imaging, 3-in-1 color depth imaging, and autofluorescence modalities combined with OCT.

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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