EW Weekly, December 7, 2018
- Dextenza approved by the FDA for ocular pain after surgery
- Photodynamic laser under development by Bausch + Lomb, Modulight
- IND cleared to begin clinical trial of QR-421a to treat Usher syndrome type 2
- Canadian regulatory approval of Iluvien announced
- Breakthrough Device designation given to patient-operated OCT system
- Become an ophthalmology star
Dextenza approved by the FDA for ocular pain after surgery
The dexamethasone ophthalmic insert (Dextenza, Ocular Therapeutix, Bedford, Massachusetts) was approved this week by the U.S. Food and Drug Administration (FDA) for intracanalicular use to treat ocular pain following ophthalmic surgery, according to a company press release. The insert delivers dexamethasone to treat pain for up to 30 days.
Photodynamic laser under development by Bausch + Lomb, Modulight
Bausch + Lomb (Bridgewater, New Jersey) and Modulight (San Jose, California) have entered into an agreement to develop a new laser specifically designed for use with verteporfin for injection photodynamic therapy (Visudyne, Bausch + Lomb). Modulight specializes in the design and manufacturing of lasers and optics for personalized medicine. The availability of lasers that can deliver photodynamic therapy has been limited, according to a press release from Bausch + Lomb.
IND cleared to begin clinical trial of QR-421a to treat Usher syndrome type 2
The FDA has cleared the Investigational New Drug application for QR-421a (ProQR Therapeutics, Leiden, the Netherlands), a first-in-class investigational RNA-based oligonucleotide designed to treat the underlying cause of vision loss associated with Usher syndrome type 2 and nonsyndromic retinitis pigmentosa due to mutations in exon 13 of the USH2A gene, according to a ProQR press release. The company will begin to enroll patients in its Phase 1/2 STELLAR trial in the next few months, with preliminary data expected in mid-2019.
Canadian regulatory approval of Iluvien announced
Health Canada has approved Iluvien (fluocinolone acetonide sustained release intravitreal implant, Alimera Sciences, Alpharetta, Georgia) to treat diabetic macular edema (DME). Iluvien is already approved in the U.S. to treat DME in patients previously treated with corticosteroids who did not have a clinically significant increase in IOP, according to Alimera Sciences.
Breakthrough Device designation given to patient-operated OCT system
A Breakthrough Device designation has been given to the Notal Vision Home-Based Optical Coherence Tomography System (Notal Vision, Manassas, Virginia). The system is an artificial intelligence-based device for automated identification of intra- and/or subretinal fluid in the central 10 degrees of eyes diagnosed with exudative AMD. It is a lightweight device that can be operated by patients at home. Once they complete the test, if retinal fluid is detected, a report is generated and is sent to the treating physician. The device is intended for home testing between regularly scheduled clinic assessments. Notal Vision leaders anticipate bringing the home OCT device to market in 2020.
Become an ophthalmology star
ASCRS is holding open auditions for the next season of ASCRS' The Voice of Ophthalmology. Season 2 is set to premiere on Sunday, May 5 in San Diego at the 2019
ASCRS/ASOA Annual Meeting. Submit your audition video today. If selected as a contestant, you will enjoy:
- Pre-meeting publicity: Your name and topic will be featured in marketing efforts promoting ASCRS' The Voice of Ophthalmology
- Exposure to and interactions with some of the world's paramount leaders in anterior segment surgery
- Exceptional visibility during the session: Season 1 debuted to 1,200+ attendees
- Post-event publicity
- May not exceed 30 seconds
- Tell us why you should be on ASCRS' The Voice of Ophthalmology, Season 2
- Describe your proposed controversial topic in anterior segment surgery
- Explain why you think your controversial topic in anterior segment surgery is suitable for debate with an expert panel
Research briefs
- Dry eye has a significant negative impact on prolonged reading, reported S. Karakus and coresearchers in their study that evaluated the impact of dry eye signs and symptoms on short-duration out-loud and prolonged silent reading. The 116 patients in the study with clinically significant dry eye, 39 patients with dry eye symptoms only, and 31 controls all were age 50 or older. Patients completed a short-duration out-loud reading test and a 30-minute sustained silent reading test. Reading speeds and words per minute were compared among the groups. Patients with clinically significant dry eye read slower than controls for the silent reading test but not with the out-loud reading test. Those with dry eye symptoms only did not have a slower reading speed as measured with either reading test compared with controls. The vision-related Ocular Surface Disease Index subscore was independently associated with a slower reading speed (P=.02). Each 1-point increase in the corneal staining score was associated with a 10-words per minute decrease in sustained silent reading speed (P=.01). A prolonged reading task may be an objective and clinically relevant test to measure the impact of dry eye on vision-related quality of life, the researchers concluded. The study is published in Optometry and Vision Science.
- Use of a swept source (SS)-OCT device allowed for quantification and documentation of cataract density, reported João E.G., Brás, MSc, and coresearchers. Their prospective multicenter case series focused on the development of a cataract quantification method using the SS-OCT device IOLMaster 700 (Carl Zeiss Meditec, Jena, Germany). Among 186 eyes (113 patients), two independent examiners performed Lens Opacities Classification System II (LOCS II) grading at the slit lamp independently as well as corrected distance visual acuity, contrast sensitivity, and SS-OCT measurements. Correction between the examiners' LOCS grading was good (0.91; P<.01). Correlation between LOCS grading and the OCT-based cataract quantification system score was 0.86 for examiner 1 and 0.76 for examiner 2 (both P<.01). The OCT-based cataract quantification system scores correlated significantly with phaco time and energy. The study appears in the Journal of Cataract & Refractive Surgery.
- In a study focusing on the 6-year incidence of cataract surgery in an Asian population-based cohort of Malay, Indian, and Chinese persons living in Singapore and factors associated with undergoing cataract surgery over the follow-up period, 1 in 10 of those 40 years or older had cataract surgery in at least 1 year. Ava Grace Tan, MPH, and fellow researchers analyzed 10,033 original participants in the Singapore Epidemiology of Eye Diseases Study and the 6,782 participants who were re-examined 6 years later. Detailed eye exams took place at both visits, and logistic regression models were used to assess factors associated with cataract surgery. The incidence of cataract surgery was strongly age-related. However, after adjustment, baseline factors associated with incident cataract surgery were older age, diabetes, myopia, and baseline presence of any cataract. Population-attributable risks of cataract surgery related to diabetes and myopia were 17.6% and 19.1%, respectively. The latter are potentially modifiable factors, according to the authors. The study appears in Ophthalmology.
- In a survey focused on the practice patterns among study investigators in the Zoster Eye Disease Study (ZEDS), approximately 50% treated herpes zoster ophthalmicus with prolonged oral antivirals and topical steroids, reported Danielle Lo, MD, and coresearchers. They sent an internet-based survey to 170 of the ZEDS investigators and had a 72.4% response rate. The topical steroids and oral antivirals were used by most respondents for stromal keratitis in recent-onset (69.1%) and chronic herpes zoster ophthalmicus (63.4%). Treatment duration was similar for both. Nearly 71% of respondents think that oral antivirals are effective during treatment. The research is published in Cornea.
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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