EyeWorld Weekly Update, July 21, 2017

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July 21, 2017
Volume 23 , Number 25

Twelve-month topline safety results announced for netarsudil/latanoprost

The 12-month safety results of netarsudil/latanoprost (Roclatan, Aerie Pharmaceuticals, Irvine, California) were announced this week for the Mercury 1 Phase 3 registration trial. Mercury 1 is a 12-month safety and efficacy trial with a 90-day efficacy endpoint. Safety results during the 12-month period were consistent with those seen in the trial's 90-day efficacy period, and no new adverse events developed, according to a company press release. The most common adverse event was conjunctival hyperemia, seen in about 60% of patients. Most cases were mild and sporadic. In the trial, IOP was measured at 8:00 a.m., 10:00 a.m., and 4:00 p.m. at months 6, 9, and 12. Researchers found that IOP lowering with netarsudil/latanoprost was more effective than both latanoprost and Rhopressa (Aerie Pharmaceuticals) by a 1 to 3 mm Hg range. "Levels of IOP lowering were consistent with those observed in the Mercury 1 and Mercury 2 90-day efficacy results for all arms of the study," investigators concluded. Aerie expects to submit its New Drug Application to the U.S. Food and Drug Administration (FDA) in the first half of 2018, according to the press release.

Phase 2 results of fixed-dosed combination trial of trabodenoson announced

Top-line results for the Phase 2 fixed-dosed combination trial of trabodenoson and latanoprost (Inotek Pharmaceuticals, Lexington, Massachusetts) were announced earlier this month. Although there was a 1.2 mm Hg improvement after 28 days compared with latanoprost 0.005% alone, there was no meaningful clinical advantage in the reduction of IOP at day 56 after 4 additional weeks of treatment and dosing at night, according to a company press release. The trial enrolled 201 subjects who had an IOP of 25 mm Hg or higher and less than or equal to 34 mm Hg. The primary endpoint of the fixed-dose combination trial measured reduction of IOP from diurnal baseline after 2 months of treatment. "Based on these results and the results previously reported for our Phase 3 MATrX-1 monotherapy trial, we are evaluating the future clinical potential of trabodenoson, as well as other strategic options," said David Southwell, president and CEO of Inotek.

EvokeDx receives CE mark to assess central vision function

The EvokeDx (Konan Medical, Irvine, California) has attained a CE mark for the objective assessment of central vision function, including the diagnosis of glaucoma. The EvokeDx includes a rapid assessment of magnocellular deficits often associated with glaucoma. "In the [National Institutes of Health]-sponsored trials, our icVEP strategy had a classification accuracy of 89% to 94% for glaucoma," said Vance Zemon, PhD, professor, Yeshiva University, Albert Einstein College of Medicine Campus, New York, and co-inventor of EvokeDx. The technology will be featured at the European Society of Cataract and Refractive Surgeons (ESCRS) meeting in Lisbon, Portugal, in October.

Visual system changes that may indicate Parkinson's disease identified

Specific changes in the visual system may indicate biomarkers for the early detection and monitoring of Parkinson's disease, according to new research fromAlessandro Arrigo, MD. The research included 20 newly diagnosed Parkinson's patients who had not yet been treated (11 men and nine women) as well as 20 age- and sex-matched healthy controls who were seen by a multidisciplinary team of researchers in ophthalmology, neurology, and neuroradiology in Italy. Significant abnormalities within the visual system brain structures were found, including alterations of optic radiations, a decrease in white matter concentration, and a reduction of optic chiasm volume. Future studies can help better understand the timing of degeneration along the visual pathways, the researchers reported. Their findings are published in Radiology.

RESEARCH BRIEFS

  • Most dry eye patients have positive perceptions about the effectiveness of their dry eye treatments, according to Ahmad Kheirkhah, MD, and co-researchers. They recently evaluated patient perceptions of treatments in dry eye disease among 66 patients. Patients had a comprehensive ophthalmic assessment and used a 10-point scale to score their views on whether dry eye treatments had been effective. The mean patient age was 55.7 years old, and 79% of patients were women. About 36% strongly believed and 53% moderately believed that their dry eye treatment had been effective. Still, 10.6% did not think their treatment had been effective. Less favorably perceived treatment effectiveness had a significant association with a younger age, the use of antidepressant medications, and a higher Ocular Surface Disease Index score at enrollment. The assessment of patients' perception of treatment effectiveness should be part of clinical practice, the researchers concluded. The study is published in Cornea.
  • Eye abnormalities may be the initial finding of congenital Zika virus infection, reported Andrea Zin, MD, and co-researchers. Their cohort case series included 112 infants born to mothers with polymerase chain reaction-confirmed Zika virus infection. Among the infants, 24 (21.4%) had eye abnormalities. Ten (41.7%) of the infants with abnormal eye findings did not have microcephaly and eight (33.3%) did not have central nervous findings. Two (8.3%) infants with eye abnormalities were born to women infected in the third trimester. Current guidelines recommend eye screening for infants with microcephaly or laboratory-confirmed Zika virus infection but not for all infants potentially exposed to Zika in utero. All infants with potential Zika virus exposure should have eye screenings, the authors concluded. The research is published in JAMA Ophthalmology.
  • Multifocal IOL exchange can be performed safely with good visual outcomes using different IOL types, reported Eric Kim, MD, and coauthors. Their retrospective case series evaluated the refractive outcomes after multifocal IOL exchange. The 29 patients (35 eyes) in the study had multifocal IOL explantation followed by IOL implantation. Outcomes evaluated included type of IOL, surgical indication, corrected distance visual acuity, and refractive prediction error. The IOLs implanted after multifocal IOL explantation included in-the-bag IOLs (74%), iris-sutured IOLs (6%), sulcus-fixated IOLs with optical capture (9%), sulcus-fixated IOLs without optic capture (9%), and anterior chamber IOLs (3%). Indications for IOL exchange included blurred vision (60%), photic phenomena (57%), photophobia (9%), loss of contrast sensitivity (3%), and multiple complaints (29%). In 94% of cases, the corrected distance visual acuity was 20/40 or better before the exchange and 100% after the exchange. "A lower refractive prediction error and a higher likelihood of 20/40 or better vision can be achieved with the implantation of the second IOL compared with the original multifocal IOL, regardless of the final IOL position," the authors concluded. The research appears in the Journal of Cataract & Refractive Surgery. 

PRODUCT NEWS

  • The U.S. Food and Drug Administration (FDA) approved the use of the Star S4 IR Excimer Laser System and iDesign System (Johnson & Johnson Vision, Santa Ana, California) for LASIK patients with hyperopia, with and without astigmatism.

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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