EyeWorld Weekly Update, August 17, 2018

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August 17, 2018
Volume 24 , Number 30

Hydrus Microstent Device approved for MIGS

The U.S. Food and Drug Administration (FDA) has approved the Hydrus Microstent (Ivantis, Irvine, California) to treat patients with mild to moderate primary open angle glaucoma along with cataract surgery, according to a company press release. The approval is based on the HORIZON trial, which included 556 mild to moderate glaucoma patients having cataract surgery and who were randomized to receive cataract surgery plus the microstent or cataract surgery alone.

Topline results announced for Rhopressa study

Aerie Pharmaceuticals (Durham, North Carolina) announced topline results from a double-masked, randomized, placebo-controlled study to evaluate the effect of netarsudil ophthalmic solution (Rhopressa) on aqueous humor dynamics in patients with primary open angle glaucoma or ocular hypertension. The study is the first performed on glaucoma patients that confirms the agent lowers IOP primarily through the trabecular meshwork outflow, according to a company press release. The study's main endpoint was mean change from baseline in mean diurnal outflow facility. Netarsudil ophthalmic solution had a statistically significant increase in trabecular outflow facility of about 35% over baseline, the company reported.

FDA provides complete response letter for Eylea

The FDA has issued a complete response letter in relation to the supplemental Biologics License Application for aflibercept (Eylea, Regeneron Pharmaceuticals, Tarrytown, New York) for patients with wet age-related macular degeneration. The supplemental Biologics License Application was based on second-year data from the VIEW studies, during which patients followed a modified 12-week dosing schedule. Eylea is currently approved for 4- to 8-week dosing intervals after three initial monthly doses. Completion of discussions with the FDA and a final FDA action are expected in about 2 months, according to a Regeneron press release.

Results announced for microdose latanoprost

Eyenovia (New York) announced results from a proof-of-concept study for EYN PG21. The study of EYN PG21, a microdose latanoprost, focused on patient usability and lowering IOP. The study investigated medication administration effectiveness and the IOP lowering effect of microdose latanoprost 0.005% in 60 eyes of 30 healthy volunteers who received a once-daily microdose treatment over 2 days and had diurnal IOP measurements four times a day. The primary outcome was successful microdose delivery. After a brief training, investigators successfully administered the piezo-print latanoprost with a single spray 95% of the time, according to a company press release. There was also an 88% success rate of patient self-administration. These rates are higher than the success rate reported in the literature with a conventional eyedropper, according to the release.

Glaukos, D. Western Therapeutics to collaborate

Glaukos (San Clemente, California) and D. Western Therapeutics (Nagoya, Japan) have begun a collaboration agreement to conduct joint research to develop new intraocular products to treat glaucoma. The development will focus on compounds from D. Western Therapeutics' proprietary ROCK inhibitor compound library. Glaukos will conduct the evaluation and development of the compounds, according to a company press release.

Register and book housing now for 2018 Young Eye Surgeons Advanced Cataract Training

ASCRS has a program designed specifically for residents, fellows, and surgeons in their first 5 years of practice, Young Eye Surgeons (YES) Advanced Cataract Training. Registration is open for this year's event, September 15-16 in San Francisco. YES Advanced Cataract Training provides in-depth education to increase exposure to advanced cataract training and features hands-on wet labs, video case presentations, and roundtable discussions with leading experts. Register and book housing now.

RESEARCH BRIEFS

  • There was a chronic endothelial cell loss of about 10% over 5 years in eyes implanted with the Artiflex Myopia and Artiflex Toric IOLs (Ophtec, Groningen, the Netherlands), reported Soraya Jonker, MD. The prospective clinical cohort study focused on long-term endothelial cell density changes after implanting the IOLs to treat myopia and astigmatism. A total of 146 eyes from the myopic group and 64 eyes from the toric group completed the 5-year follow-up. The main outcome measures were chronic endothelial cell loss, percentage of eyes with a 25% or greater decrease in endothelial cell density, and percentage of eyes with an endothelial cell density of 1,500 cells/mm2 or less. There was an annual chronic endothelial cell loss of 64 cells/mm2 in the myopic group and 62 cells/mm2 in the toric group. The total chronic endothelial cell loss between 6 months and 5 years postop was 10.5% in the myopic group and 10.2% in the toric group. Significant endothelial cell loss led to subsequent IOL explantation in 3.1% of eyes. The study is published in the American Journal of Ophthalmology.
  • A patient education video for cataract surgery led to reduced physician counseling time but similar comprehension and patient-reported satisfaction compared with traditional patient counseling, reported Thomas Vo, MD, and coresearchers in their single-center prospective randomized controlled trial. The patients enrolled in the trial were randomized to receive face-to-face surgeon-informed consent with a preceding education video or face-to-face surgeon-informed consent alone. The comprehension rate was 79.4% for those who watched the video compared with 79.3% for those who received only face-to-face surgeon instruction. The surgeon counseling time was 117.5 seconds in the video group versus 241.6 seconds for those with only face-to-face instruction. The research appears in Clinical Ophthalmology.
  • A retrospective case series analyzing IOL power calculation formulas for a quadrifocal IOL found that the Barrett Universal II, Hill-RBF, Olsen, and T2 formulas were the most accurate, reported Mehdi Shajari, MD, and coresearchers. The 75 eyes of 38 patients in the study included patients having cataract surgery, with preop biometry measurements obtained from an IOLMaster 500 (Carl Zeiss Meditec, Jena, Germany). Optimized IOL constants were calculated to lower the mean refractive prediction error. Researchers analyzed median and maximum absolute prediction errors and percentage of eyes within prediction errors of 0.25 D, 0.50 D, and 2.00 D. Formulas ranked by the mean absolute refractive prediction error were Barrett Universal II (0.294 D), Hill-RBF (0.332 D), Olsen (0.339 D), T2 (0.351 D), Holladay 1 (0.381 D), Haigis (0.382 D), SRK/T (0.393 D), Holladay 2 (0.399 D), and Hoffer Q (0.410 D). There were significant differences in absolute errors among the formulas; the lowest maximum absolute prediction error occurred with the Barrett Universal II. The study is published in the Journal of Cataract & Refractive Surgery.
  • A longer corneal preservation time was not associated with a higher rate of positive donor rim cultures in the Cornea Preservation Time Study, according to Shahzad Mian, MD, and coresearchers. Researchers assessed donor characteristics for association with positive cultures using Fisher exact test and Poisson regression analysis. Among 1,330 cases, cultures were performed in 784 (58.9%) cases. Positive fungal growth occurred in 10 of 397 (2.5%) versus 5 of 387 (1.3%) corneas (P=0.30); positive bacterial cultures occurred in 6 of 397 (1.5%) versus 4 of 387 (1%) corneas (P=0.75). Tissue that was surgeon-prepared remained a significant risk for positive fungal cultures; younger donors and accidental death donors were at a greater risk for positive bacterial cultures. Among those with a positive fungal culture, 1 (6.7%) of 15 recipients developed a fungal infection (Candida glabrata); no recipient infections occurred with positive bacterial culture. A total of 2 of 1,330 eyes (0.15%) developed fungal infections, and 1 (0.08%) developed a bacterial post-keratoplasty infection. The infection rate overall was low. The study 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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