EyeWorld Weekly Update, November 17, 2017

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November 17, 2017
Volume 23 , Number 40

HORIZON pivotal study for MIGS device meets 2-year primary endpoint

The HORIZON trial for the Hydrus Microstent (Ivantis, Irvine, California) met both its 2-year primary and secondary pre-established endpoints, according to a company press release. The HORIZON study is the largest prospective, randomized, controlled trial to date for a MIGS device. The study includes 556 patients and took place at 38 centers in nine countries on three continents. Data presented by Paul Harasymowycz, MD, at the 2017 American Academy of Ophthalmology (AAO) annual meeting showed that 77.2% of Hydrus Microstent patients had a 20% or greater reduction in IOP compared to 57.8% in the cataract-only group. The Hydrus Microstent also reduced IOP 43% more than cataract surgery alone (7.6 mm Hg versus 5.3 mm Hg). Seventy-eight percent of Hydrus Microstent patients remained medication-free compared with 48% in the control group.

Patient randomization begins in Phase 2b/3 trial for dry eye treatment

Patient randomization began earlier this month in the ESSENCE Phase 2b/3 trial for CyclASol (Novaliq, Heidelberg, Germany) for the treatment of dry eye disease. CyclASol is a preservative-free ophthalmic solution of cyclosporine A in EyeSol, which is the company's proprietary water-free technology. The ESSENCE Phase 2b/3 trial is a randomized, double-masked, vehicle-controlled multicenter trial that randomizes patients to one of two treatment groups, CyclASol and vehicle. The study is underway at 10 sites in the U.S. with a planned enrollment of 316 patients. A previous studied showed excellent safety and tolerability for CyclASol, according to a company press release.

Enrollment completed in Phase 2b trial for cataract surgery agent

Enrollment in the Phase 2b trial for EGP-437 combination product for pain and inflammation after cataract surgery (EyeGate Pharmaceuticals, Waltham, Massachusetts) has been completed. The study includes 100 subjects at eight clinical sites around the U.S. The double-masked, randomized, placebo-controlled trial is set up to assess the safety and efficacy of transscleral iontophoretically delivered EGP-437 through the EyeGate II Delivery System in patients who have had cataract surgery and implantation of a monofocal posterior chamber IOL. The primary efficacy endpoint will be the proportion of subjects with an anterior chamber cell count of zero at day 7 and the proportion of subjects with a pain score of zero at day 1.

Expedited Access Pathway designation given to Orion Cortical Visual Prosthesis System

The U.S. Food and Drug Administration (FDA) granted its Expedited Access Pathway designation to the Orion Cortical Prosthesis System (Second Sight Medical Products, Sylmar, California). This designation is used for some medical devices to expedite their development, assessment, and review, according to a company press release.

EyeMD EMR acquires healthcare internet technologies ASC software

EyeMD EMR Healthcare Systems (Bonita Springs, Florida) acquired a software product for eyecare ambulatory surgical systems from HCIT (Owings Mills, Maryland). The acquisition makes the EyeMD EMR portfolio of ophthalmology-specific technologies stronger and positions the company to move ahead in its quest to bring an ASC solution to the market, according to a company press release.

One World Sight Alliance forms

The Lions Eye Institute for Transplant and Research launched One World Sight Alliance, a global network to eradicate preventable blindness with international tissue distribution, physician training, and eye bank development. The move creates a growing network of more than 20 eye banks that distribute 15,000 corneas annually across the U.S. and the world, according to a company press release.

Register today for complimentary ASCRS webinar on November 29

On Nov. 29 at 9:00 p.m. EST, the ASCRS IOL Power Calculation Subcommittee will sponsor a complimentary webinar, " Optimizing IOL Power Calculations and Outcomes." This webinar will cover how to maximize cataract surgery refractive outcomes through a better understanding of available technology. Participants will join moderator Warren Hill, MD, facilitator Helga Sandoval, MD, and panelists Li Wang, MD, and Robin Vann, MD, for a dynamic learning experience featuring case presentations, panel discussion, and frequent audience participation. Register today. The ASCRS webinar series addresses important clinical issues directly relevant to anterior segment membership. The goal of these webinars is to supplement traditional educational curricula by providing additional quality education on relevant topics through technology.

RESEARCH BRIEFS

  • With the aging of the U.S. population, there is a substantial need for low vision resources, according to Tiffany Chan, OD, and fellow researchers in their study that estimated the incidence and prevalence of visual impairment, low vision, and blindness. They used data from 6,016 participants in the 2007-2008 National Health and Nutrition Examination Survey. Their estimates predict a doubling in the number of low vision and blindness cases within 30 years. Researchers estimated the prevalence of low vision and blindness in adults 45 years or older in the U.S. in 2017 to be 3.89 million people with a best corrected visual acuity (BCVA) of less than 20/40, 1.48 million with a BCVA less than 20/60, and 1.08 million with a BCVA of 20/200 or less. The estimates can help policy planners allocate resources, the researchers wrote. The research appears in JAMA Ophthalmology.
  • First eye cataract surgery significantly reduced patient falls, although major changes in the dioptric power of spectacle correction of the operated eye after surgery increased fall risk, reported Anna Palagyi, PhD, and fellow researchers. Their prospective cohort study included patients who had bilateral cataract, were aged 65 and older, and were on public hospital cataract surgery waiting lists in Australia. Of the 329 patients who were recruited, 66.6% had first eye surgery in the study period. The first eye cataract surgery reduced incident falls by 33%; poorer dominant eye visual acuity was associated with falls during the study timeline. Those who had a larger than ±0.75 spherical equivalent diopter change had a two-fold greater incidence of falls after first eye cataract surgery compared with those with less or no change in lens power. The researchers recommended cautious postop refractive management to maximize the benefit of cataract surgery as a fall prevention measure. The research appears in the Journal of Cataract & Refractive Surgery.
  • Even before diabetic retinopathy is present, macular thickness is reduced in prediabetes and type 2 diabetes, according to Eline E.B. DeClerck and co-researchers. They used spectral domain OCT to measure macular thickness in six subfields as defined by the Early Treatment Diabetic Retinopathy Study in 1,838 participants from The Maastricht Study. Individuals with prediabetes had a significant decrease in pericentral superior macular thickness compared with those who had normal glucose metabolism. In those who had type 2 diabetes but no diabetic retinopathy, the fovea and the four pericentral quadrants were significantly thinner compared with individuals who did not have diabetes. There was also a significant trend of macular thinning with the severity of glucose metabolism status in five subfields. Generalized thinning of the macula could be related to thinning of the temporal side of the optic nerve head through the connecting papillomacular bundle, the researchers concluded. The study appears in Acta Ophthalmologica.
PRODUCT NEWS
  • LENSAR (Orlando) received 510(k) clearance from the U.S. FDA and the European Union CE mark for IntelliAxis-L, a new feature with the latest LENSAR Laser System upgrade, Streamline IV. IntelliAxis-L is a unique reference mark that leverages the company's integrated preoperative diagnostic capabilities, iris registration, and intraop imaging to identify the location of the steep corneal axis at the capsular plane for toric IOL alignment.
  • A new Tear Film Analyzer (Visiometrics, Costa Mesa, California) is designed to measure vision fluctuation caused by dry eye disease.

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; Reay Brown, MD, glaucoma editor; and Vance Thompson, MD, refractive editor.

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