EyeWorld Weekly Update, November 3, 2017

November 3, 2017
Volume 23 , Number 39

Premarket approval submission for Hydrus Microstent completed

Premarket approval for the Hydrus Microstent (Ivantis, Irvine, California) has been completed and submitted to the U.S. Food and Drug Administration (FDA) for market approval. There are plans to bring the microstent to the market in 2018. Related to the submission is the HORIZON prospective, randomized trial with 556 patients. Patients in the trial were at 38 centers in nine countries and were followed for 2 years. Study subjects had mild to moderate primary open angle glaucoma and had cataract surgery. Subjects received cataract surgery alone or cataract surgery plus the Hydrus Microstent. To date, the HORIZON trial is the largest microinvasive glaucoma surgery (MIGS) randomized controlled trial, according to a company press release.

FDA approves NDA for VYZULTA

Bausch + Lomb (Bridgewater, New Jersey) and Nicox (Sophia Antipolis, France) announced that the U.S. Food and Drug Administration (FDA) approved the New Drug Application (NDA) for VYZULTA (latanoprostene bunod ophthalmic solution, 0.024%). VYZULTA, the first prostaglandin analog with one of its metabolites being nitric oxide, is indicated for the reduction of IOP in patients with open angle glaucoma or ocular hypertension.

First-in-human MIGS trial for MINIject completed

MINIject (iSTAR Medical, Wavre, Belgium), a MIGS device, has completed enrollment of its first-in-human trial. The study recruited 25 mild to moderate open angle glaucoma patients uncontrolled by topical hypotensive medications for MINIject implantation, according to a company press release. Patients were enrolled between June and October 2017. The study will assess the safety and performance of MINIject as measured by IOP reduction under medication from baseline to 6 months. Safety and performance will then be measured at 12 and 24 months postoperatively. The MINIject uses STAR material, a soft and flexible medical-grade silicone that conforms to the eye anatomy.

Nicox collaborates with Re-Vana Therapeutics for standalone nitrous oxide donors

Nicox (Sophia Antipolis, France) has entered into a collaboration with Re-Vana Therapeutics (Belfast, Northern Ireland) to explore the combination of Nicox's standalone nitric oxide donors with Re-Vana's EyeLief long-acting photo-crosslinked biodegradable drug delivery platform to reduce IOP. Re-Vana will be responsible for the development and characterization of EyeLief implants containing Nicox's nitric oxide donors and subsequently for initial in-vitro evaluation of the implants' sustained-release characteristics over a number of months, according to a company press release. Nicox and Re-Vana may enter into discussions regarding further product candidates, depending on the outcome of the research collaboration.

Annual Meeting deadline: Submit complicated and challenging cases by Nov. 7

You still have time to submit your entry for the Complicated and Challenging Cases in Cataract Surgery Video Symposium, sponsored by the ASCRS Cataract Clinical Committee. The symposium will take place on Monday, April 16, 2018, from 8:00-9:30 a.m. at the 2018 ASCRS/ASOA Annual Meeting in Washington, D.C. Speakers will have the opportunity to present unusual and challenging video cases from their practice involving any aspect of phaco, femtosecond laser-assisted cataract surgery, and IOLs. Presenters will have no more than 5 minutes to describe the clinical aspects of the case. The Cataract Clinical Committee panel and other audience members will then discuss the case for 3-4 minutes, and the panel will award the "Golden Apple" to the best teaching case. The selection criteria will emphasize clinical and educational merit. If you plan to attend the meeting and would like to participate in this special session, please contact Jennifer Carstens, jcarstens@ascrs.org, for an invitation to upload a copy of your video to the ASCRS Dropbox account. All videos must be received via Dropbox by Tuesday, Nov. 7, 2017. Only one submission per presenter is allowed.

*Please be certain your video is created as an MPEG or Windows Media file (.wmv). No exceptions will be made. A maximum of two PowerPoint slides should be included (one containing title and financial interest and the second with a brief case history). If your video will not include narration, please note this in the PowerPoint slide.


  • Cataract surgery was associated with a lower risk for total and cause-specific mortality in a prospective cohort study from the Women's Health Initiative (WHI) clinical trial. The study, led by Victoria Tseng, MD, included 74,044 participants with cataract from the WHI trial and observational study data linked with the Medicare claims database. Participants were 65 years or older and had a diagnosis of cataract in the Medicare claims database. Data for the WHI were collected between 1993 and 2015, but data for this specific study were analyzed from July 2014 to September 2017. Outcomes that researchers focused on included all-cause mortality and mortality linked to vascular, cancer, accidental, neurologic, pulmonary, and infectious causes. The mortality rate was 2.56 per 100 person-years. Cataract surgery was associated with lower all-cause mortality (adjusted hazards ratio, 0.40; 95% confidence interval, 0.39-0.42) and lower mortality specific to all other mortality causes. It is not yet clear if this association is explained by cataract surgery intervention, according to the researchers. The study appears in JAMA Ophthalmology.
  • Significantly worse baseline patient-reported vision-related function was found in central retinal vein occlusion (CRVO) and hemiretinal vein occlusion (HRVO) patients in the Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2) trial, according to Ingrid Scott and fellow researchers. Their multicenter, non-inferiority, randomized controlled clinical trial used the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) in patients with macular edema secondary to CRVO or HRVO. The SCORE2 trial enrolled 362 patients (305 with CRVO and 57 with HRVO). The baseline NEI-VFQ 25 baseline composite and subscale scores were significantly lower with three normal vision reference populations and similar to patients in other retinal vein occlusion trials. The NEI-VFQ 25 composite and subscale scores of general vision, near activities, role difficulties, dependency, and color vision were correlated with baseline visual acuity letter score in the better eye. The worse baseline patient-reported vision-related function occurred despite the disease being primary unilateral, with typically excellent vision in the fellow eye, the researchers reported. The study appears in the American Journal of Ophthalmology.
  • Although patients with glaucoma are generally satisfied with their glaucoma care, one in four patients were dissatisfied with three specific aspects of care, according to a study in Singapore led by Valencia Hui Xian Foo. Researchers focused on adult patients seen by a specialist glaucoma service in a tertiary eye hospital between March and June 2014. Patients completed a seven-area glaucoma-specific satisfaction questionnaire. Among the 438 patients who completed the study, the patient dissatisfaction rate with the overall glaucoma service was 7.5%. The three areas with the highest dissatisfaction levels were explanation of test results (24.8%), explanation of glaucoma complications (23.7%), and advice on managing glaucoma (23.5%). Dissatisfied patients had a worse mean visual acuity compared with satisfied patients. A lower IOP and lower education level were both associated with more overall dissatisfaction. The study appears in Clinical Ophthalmology.
  • Restoration of bacterial flora after cataract surgery and topical levofloxacin use took more than 6 months, according to Takashi Ono, MD, and fellow researchers in their prospective case series. The 50 study patients had levofloxacin 1.5% administered four times a day topically from 3 days preoperatively to 1 month postop. The conjunctival sacs of patients were scraped before the procedure and at 0, 3, 6, 9, and 12 months. Samples were cultured, and minimum inhibitory concentrations (MICs) of levofloxacin for Staphylococcus epidermis and Propionibacterium acnes were evaluated. Bacterial diversity drastically reduced after the final levofloxacin application and increased after 3 months. The geometric mean levofloxacin MICs for S. epidermis isolates were still significantly higher at 0 and 3 months and reached pretreatment levels 6 and 12 months after the last application. No significant changes in P. acnes were seen in the geometric mean levofloxacin MIC over time. The research is published in the Journal of Cataract & Refractive Surgery.

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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