EW Weekly, November 16, 2018

November 16, 2018
Volume 24 , Number 45

Phase 2a trial data for avacincaptad pegol/ranibizumab for wet AMD released

In a Phase 2a trial of avacincaptad pegol (Zimura, Ophthotech, New York) combined with ranibizumab (Lucentis, Genentech, South San Francisco), the therapy was generally well tolerated after 6 months of treatment, according to an Ophthotech press release. Adverse events related to the injection site were the most frequently reported safety issue; there were no adverse events attributed to Zimura combination therapy. The trial was designed to measure the safety of different dosages of Zimura combination therapy in wet AMD. It also was the first-in-human trial to assess the safety of a 4 mg dose of Zimura combined with Lucentis. There were 64 patients enrolled and treated.

Voluntary recall initiated for Puriton eye drops

Kadesh (Garden Grove, California) has voluntarily recalled Puriton Eye Relief Drops due to non-sterile production conditions. During a recent U.S. Food and Drug Administration (FDA) inspection, investigators observed that the drops were manufactured without necessary production controls and conditions to assure sterility, according to the FDA website. Kadesh has not received any reports of adverse events related to the recall. The over-the-counter homeopathic drops are for the temporary relief of burning and irritation due to dryness and eye discomfort. Any questions can be addressed by emailing contact@puriton.us.

Compact Imaging partners with Novartis for home-based AMD disease monitoring

Compact Imaging (Mountain View, California) will collaborate with Novartis Pharma AG (Basel, Switzerland) to develop a low-cost, home-based monitor to detect disease progression in advanced cases of AMD and diabetic retinopathy. The home retinal monitoring is based on Compact's proprietary Multiple Reference Technology. The collected OCT information will be transmitted via cloud to treating physicians. If there is significant disease progression, patients will be notified by their physicians to set an appointment for a complete diagnostic exam and possibly treatment. Clinical trials with a prototype of the system in patients with an active AMD or diabetic macular edema diagnosis are expected in the second half of 2019.

Collaboration with Johnson & Johnson Vision and Singapore National Eye Centre to focus on myopia

A collaboration between the Singapore National Eye Centre, the Singapore Eye Research Institute, and Johnson & Johnson Vision (Santa Ana, California) will focus on myopia treatment. The first-of-its-kind public/private strategic partnership will focus on how myopia develops in Asia, how it progresses, and how it can be intercepted, according to a press release. It is a $26.35 million research collaboration.

J-code assigned for dexamethasone intraocular suspension

The Centers for Medicare and Medicaid Services (CMS) has assigned a permanent reimbursement J-code for Dexycu (dexamethasone intraocular suspension, EyePoint Pharmaceuticals, Watertown, Massachusetts). The code is issued through the Healthcare Common Procedure Coding System. The code, J1095, will go into effect Jan. 1, 2019, and will replace the previous C-code of C9034. The company still retains transitional pass-through status for Dexycu from CMS for about 3 years, according to a company press release.

SEC settles insider trading claims against former chairman and CEO of Advanced Medical Optics

The Securities and Exchange Commission (SEC) announced on Nov. 13 that it has agreed to resolve its insider trading claims against James V. Mazzo, the former chairman and chief executive officer of Advanced Medical Optics, Inc. (AMO) for allegedly releasing information about AMO's potential acquisition by Abbott Laboratories. According to the SEC press release, without admitting or denying the allegations, Mazzo agreed to a final judgment that includes a permanent injunction from violations of the antifraud and tender offer provisions of the Exchange Act, an order to pay a $1.5 million civil penalty, and a five-year officer-and-director bar. The settlement is subject to final approval by the court.

The Voice of Ophthalmology Season 2 is now accepting auditions

ASCRS is getting ready for another year of the most widely acclaimed, innovative educational forums in anterior segment surgery! ASCRS' The Voice of Ophthalmology, Season 2, is set to premiere on Sunday, May 5. This season ASCRS is holding open auditions November 12-December 14, 2018. That means you have the opportunity to take center stage as a contestant. Selected contestants will enjoy:

  • Pre-meeting publicity: your name and topic will be featured in marketing efforts promoting ASCRS' The Voice of Ophthalmology
  • Exposure to and interactions with some of the world's paramount leaders in anterior segment surgery
  • Exceptional visibility during the session. Season 1 debuted to 1,200+ attendees!
  • Post-event publicity
Audition videos can be submitted via text at 703-717-3770 or email at ASCRSVoice@ascrs.org. Full audition details are available online at voice.ascrs.org. Don't wait-submit your audition video today.

Research brief

  • Intraocular foreign bodies in soldiers who fought in Operation Iraqi Freedom or Operation Enduring Freedom are common and are associated with more severe injuries, according to Grant A. Justin, MD, and coresearchers. Their retrospective case series included 890 eyes of 652 patients who were admitted to Walter Reed Army Medical Center, Washington, D.C., from 2001 to 2011. However, the foreign bodies were not found to predict the final visual acuity of <20/200 in a multivariate analysis when other injury features were known. Pars plana vitrectomy was done in 75% of the eyes with intraocular foreign bodies; removal of the foreign body was performed in 71% of eyes. Retina detachment occurred in 29% of eyes, and proliferative vitreoretinopathy occurred in 26.5% of eyes. The study appears in Ophthalmology.
Cataract study on mortality retracted and replaced
  • In June 2018, EyeWorld ran a research highlight titled "New benefit of cataract surgery," about a JAMA Ophthalmology article published online in October 2017 and in print in January 2018. The article examined the impact cataract surgery could have on an older patient's mortality, and the EyeWorld piece summarized the findings and interviewed one of the study authors. At the time, the study investigators said that undergoing cataract surgery could lower the risk of death from all causes for patients age 65 and older. However, this conclusion was subsequently found to be erroneous. In August 2018 online (and then in print in November 2018), the authors withdrew the original article and replaced the study with a revised version that concluded the opposite: that older individuals who underwent cataract surgery were actually at increased risk of mortality.
  • An issue with one of the variables used in the study prompted the retraction and replacement. In the retraction notice, the authors explained that after being contacted by a reader who questioned the time-varying model used in the study, they re-examined the data. They realized that they had mistakenly defined the time-to-event variable as the period since undergoing cataract surgery, rather than using the diagnosis date as the starting point. The investigators determined that their original conclusion was, for the most part, no longer valid. The only exception was mortality related to neurological issues, which was still lower in those over 65 who underwent the cataract procedure.
  • EyeWorld wants to alert readers of this new conclusion, which turned out to be so very different from the original. We are sharing this extended explanation to help ensure our readers remain apprised of these latest findings and what they could mean for older patients considering cataract surgery.
Product news
  • Princeton Instruments (Trenton, New Jersey) has introduced the SpectraPro HRS-750, a new 750-mm focal length spectrographic and scanning monochromator.

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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