EyeWorld Weekly Update, April 28, 2017

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April 28, 2017
Volume 22 , Number 17

Clinical trial given FDA clearance for Hydrus Microstent

The U.S. Food and Drug Administration (FDA) has granted clearance for a second investigational device exemption clinical trial for the Hydrus Microstent (Ivantis, Irvine, California). The trial will include patients who have advanced glaucoma and who will have standalone glaucoma surgery without combined cataract surgery. The SUMMIT trial will enable Ivantis to study the microstent in more challenging glaucoma cases. It will include the 12-month safety and effectiveness in 60 advanced glaucoma patients who have been unsuccessful with convention IOP-lowering therapies. "Ivantis is conducting this study to show that the Hydrus Microstent can combine the efficacy required for a later-stage approach with the safety surgeons demand for the treatment of early-stage patients," according to a company press release. The Hydrus Microstent has already been studied in mild to moderate cataract/glaucoma cases, the company reported. Previous trials include the HYDRUS II study and the HORIZON Study. Ivantis anticipates a 2018 FDA approval of its microstent.

Phase 3 trial begins for agent to treat infectious conjunctivitis

A Phase 3 clinical program has been initiated for SHP640 (Shire, Lexington, Massachusetts), a combination broad-spectrum antiseptic and corticosteroid in development to treat infectious conjunctivitis. The agent is also undergoing evaluation for adenoviral and bacterial conjunctivitis. Called SYNCHRONIZE, the Phase 3 clinical program will include four multicenter, randomized, double-masked, placebo-controlled studies that will enroll more than 2,700 patients from the U.S. and globally. Two of the studies will focus on adenovirus conjunctivitis and two on bacterial conjunctivitis; the studies will examine the efficacy, safety, and tolerability of SHP640. One patient has already been enrolled in the U.S., and additional international clinical trial sites are expected to open in the third quarter of this year. SHP640 is a combination treatment with povidone-iodine and dexamethasone 0.1%; the treatment regimen is slated as one drop, four times a day, for a week.

FDA accepts NDA for intravitreal sirolimus for posterior segment uveitis

The FDA has accepted for review the New Drug Application (NDA) for intravitreal sirolimus (Santen, Osaka, Japan) to treat non-infectious uveitis of the posterior segment. An mTOR inhibitor, intravitreal sirolimus is an investigational, first-in-class targeted immunoregulator. The NDA for the drug is supported by data from the SAKURA program, the largest global clinical program to date to evaluate patients with non-infectious uveitis of the posterior segment, according to a Santen press release. The FDA has set an action date of December 24 of this year to complete its review of the intravitreal sirolimus NDA. The agent was granted orphan drug designation by the FDA and the European Commission in 2011.

Chemical reaction discovered in the eye could help improve vision

A light-sensing pigment that can be biochemically manipulated to reset itself could offer a therapeutic advantage, according to researchers at Case Western Reserve University School of Medicine, Cleveland. The investigators, led by Sahil Gulati and Krzysztof Palczewski, PhD, used a modified form of vitamin A called locked retinal to induce the recycling mechanism and engage proteins central to vision. The proteins they targeted included light-sensing rhodopsin, which is part of a family of proteins located in cell membranes and that transmit external cellular cues into internal cell signaling pathways. "The discovery opens a new therapeutic opportunity for modified retinals that help improve vision and offers a major improvement over current therapeutics designed to perturb cell signaling in the eye," according to a Case Western press release. The findings could potentially enhance current approaches to treat retinal degenerative diseases and other nerve cell disorders. The research is published in the Proceedings of the National Academy of Sciences.

RESEARCH BRIEFS

  • Optic rehabilitation of pediatric cataract is a crucial factor in strabismus development, according to N. Sefi-Yurdakul and A.T. Berk. The investigators compared the visual outcomes of primary and secondary IOL implantations and identified risk factors for strabismus development in pediatric patients who had cataract surgery between January 1999 and November 2014. In this retrospective review, results from 220 eyes (148 patients) with cataract extraction with primary IOL implantation and secondary IOL implantation were compared, as were the risk factors for strabismus development. The mean patient age was 6.48 years for the primary group at the time of cataract extraction/primary posterior chamber IOL implantation and 8.92 years for the secondary group during secondary IOL implantation. Strabismus occurred in 28 (23.7%) patients in the primary group and nine patients (30%) in the secondary group. Investigators found a negative relationship between visual acuity and strabismus development and a positive relationship between the follow-up period and strabismus development. The findings are published in the Journal of Pediatric Ophthalmology and Strabismus.
  • A new study supports recent evidence that patients with idiopathic dry eye may have a centralized chronic pain condition. Led by E. Felix, the investigators analyzed associations between the degree of discordance in dry eye symptoms and signs and measures of somatosensory function. More than 150 participants were recruited from the Miami VA Clinic, Miami; they completed questionnaires and had an ocular surface examination as well as quantitative sensory testing. Each patient was given a discordance score. "Bivariate correlations showed that although there was not a significant association between discordance score and pain thresholds on the cornea or forehead, discordance scores and pain thresholds on the forearm showed modest, but significant associations," the investigators wrote. Discordance scores also related to intensity ratings of cold pain after-sensations on the forehead and hot pain after-sensations on the forearm. The preliminary results show that evoked pain sensitivity at a remote test site (in this case, the forearm) was higher for those with a larger dry eye symptom-to-sign discordance. The study appears in the Journal of Pain.
  • Cataract surgery with a femtosecond laser and conventional methods were both safe and effective, according to Anna Mursch-Edlmayr, MD, and co-investigators, who compared safety and efficacy between the Victus laser system (Bausch + Lomb, Bridgewater, New Jersey) and conventional surgery. The prospective randomized case series enrolled 50 patients. Patients in both groups had cataract surgery with IOL implantation and postoperative follow-ups at 1 day, 1 week, and 1, 3, and 6 months. Investigators measured corrective distance visual acuity, endothelial cell density, central corneal thickness, and central retinal thickness. Main outcomes were complications and effective phacoemulsification time. There were no intraoperative complications in either group. The endothelial cell density, central corneal thickness, central retinal thickness, and IOL centration were similar in both groups. There was no statistically significant difference in effective phaco time between groups. The study is published in the Journal of Cataract & Refractive Surgery. 

NEW PRODUCT BRIEFS

  • Haag-Streit received FDA approval for its Fundus Module 300 slit lamp attachment in the U.S. The product attaches directly to the slit lamp for full, stable integration with the examination process. The Fundus Module 300 is designed to enhance the functionality of Haag-Streit slit lamps. The camera is controlled by the Haag-Streit control panel (RM02), and captured images are immediately transferred to Haag-Streit's EyeSuite software.
  • Vitesse, a 100% open port vitrectomy system (Bausch + Lomb), received 510(k) clearance from the FDA. It is available on the company's Stellaris Elite Vision Enhancement System.
  • Allergan (Dublin, Ireland) has been granted marketing authorization from the FDA for TrueTear Intranasal Tear Neurostimulator, an FDA-cleared device created to temporarily increase tear production during neurostimulation.

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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