EyeWorld Weekly Update, April 27, 2018

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April 27, 2018
Volume 24 , Number 14

Shire leaders recommend takeover offer from Takeda

Executives of Shire Pharmaceuticals (Dublin, Ireland) said on Wednesday that they would recommend shareholders accept Takeda Pharmaceutical Company (Osaka, Japan) fifth offer to purchase the company. May 8 is the deadline to complete the $64 billion deal. If completed, it would be the largest Japanese acquisition of a Western company, and would create the world's eighth-largest drug maker by sales, according to the Wall Street Journal. One of Shire's products is the dry-eye agent lifitegrast (Xiidra).

SightLife Surgical rebrands as CorneaGen

SightLife Surgical (Seattle) rebranded as CorneaGen at the ASCRS*ASOA Annual Meeting in Washington, D.C., earlier this month. The name reflects the company's expansion into more products and services that change how corneal surgeons treat the cornea, according to a company press release. New offerings from the company include the addition of amphotericin B (Ampho B) to corneal storage media to help fight post-transplant fungal infections and the new Geuder Preloaded Glass Cannula for DMEK. CorneaGen also recently acquired the AcuFocus KAMRA Inlay.

Two patents issued that cover Dexycu for postop inflammation

The U.S. Patent and Trademark Office has issued two patents that cover Dexycu (EyePoint Pharmaceuticals, Watertown, Massachusetts) use as a long-acting intraocular product to treat postop inflammation. The first patent includes claims related to a method of treating inflammation in the eye following cataract surgery by delivering small amounts of dexamethasone in triethyl acetyl citrate. The second patent includes claims relating to loading and delivery of a small-dose volume from an injection syringe, according to a company news release. The patents, once issued, will expire in 2034 and 2032, respectively.

Contacts that darken in the sunlight approved by the U.S. FDA

A contact lens that automatically darkens when exposed to bright light has been approved by the U.S. Food and Drug Administration. Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology (Johnson & Johnson Vision, Jacksonville, Florida), are the first contact lens with this ability, according to a company news release. The lens has a photochromic additive that adapts to visible light that is filtered in the eye. The lens returns to a normal tint in normal or dark lighting conditions. The lens can be used to correct myopia or hyperopia and certain degrees of astigmatism and is designed for daily wear for a maximum of 14 days.

RESEARCH BRIEFS

  • A prospective interventional Phase 1/2a study is underway to assess the safety and efficacy of a composite subretinal implant in subjects with advanced non-neovascular age-related macular degeneration. The composite implant is called the California Project to Cure Blindness-Retinal Pigment Epithelium 1 (CPCB-RPE1) and is made of a polarized monolayer of human embryonic cell-derived RPE (hESC-RPE) on an ultrathin, synthetic parylene substrate designed to mimic Bruch's membrane. Led by Amir H. Kashani, MD, PhD, the researchers' interim analysis of four subjects that were successfully enrolled found changes consistent with human embryonic stem cell-derived retinal pigment epithelium and host photoreceptor integration. The eyes had no vision loss progression; one eye improved by 17 letters, and two eyes showed improved fixation. "The concurrent structural and functional findings suggest that CPCB-RPE1 may improve visual function, at least in the short term, in some patients with severe vision loss from advanced non-neovascular age-related macular degeneration," the researchers wrote. The study appears in Science Translational Medicine.
  • Low-vision rehabilitation may be more effective than basic low-vision services for veterans with macular diseases, but it requires more time commitment and cost to patients, according to Kevin T. Stroupe, PhD, and fellow researchers, reporting on results from their randomized controlled clinical trial. The U.S. Department of Veterans Affairs Low Intervention Trial took place at nine VA facilities and included 323 veterans with macular disease and a best-corrected distance visual acuity of 20/50 to 20/200. They were randomized to receive basic low-vision services that provided low-vision devices without therapy or low-vision rehabilitation that added a therapist to low-vision services and provided instruction and homework on the use of low-vision devices. The average total direct healthcare costs per patient were similar among those receiving basic low-vision services ($1,662) or low-vision rehabilitation ($1,778), but basic low-vision services required less time and had lower transportation costs. There were more improvements in overall visual ability, reading ability, visual information processing, and visual motor skill scores among veterans receiving low-vision rehabilitation. The study is published in JAMA Ophthalmology.
  • Most patients considered corneal crosslinking (CXL) effective, according to the results of a prospective case series led by Marianne O. Price, PhD, that assessed patient satisfaction with CXL. In the study, a total of 448 patients who received CXL with the Dresden protocol or accelerated epithelium-off CXL over an 8-year period were invited to complete an electronic survey. A younger treatment age was associated with a higher perceived effectiveness of treatment (P = .0003). Among those with mild keratoconus, 93% considered CXL effective; the percentages were 86% and 78%, respectively, among those with moderate to severe keratoconus and post-refractive surgical ectasia (P = .0004). After CXL, 41% reported vision improvement, 46% reported no change, and 14% said they had continued declined vision. The mean satisfaction score was 8.8 on a scale from1 (would not recommend CXL) to 10 (definitely would recommend it) among those treated for keratoconus and 7.6 for those treated for ectasia after keratorefractive surgery. The research appears in the Journal of Cataract & Refractive Surgery.
  • The use of CXL can slow down keratoconus progression in pediatric patients and improve functional performance, according to Cosimo Mazzotta, MD, PhD, and fellow researchers. Their prospective longitudinal cohort study assessed the 10-year follow-up efficacy and safety of riboflavin ultraviolet A-induced CXL in pediatric patients age 18 and under with progressive keratoconus. The surgical procedure used in all patients was the Siena (Dresden modified) protocol. There were 62 eyes of 47 patients who completed the epithelium-off CXL and the 10-year follow up. The uncorrected distance visual acuity and corrected distance visual acuity improved from 0.45 to 0.23 logMAR and from 0.14 to 0.1 logMAR. Keratoconus stability was recorded after 10 years in about 80% of patients; the overall progression rate over 10 years was 24%, included 13 eyes of nine patients with Kmax progression >1 D and two eyes of two patients who had corneal grafting. Long-term stability may be correlated with CXL-induced delay in corneal collagen turnover and with spontaneous age-related keratoconus stabilization, the researchers concluded. The study is published in Cornea.
PRODUCT NEWS
  • A new Cornea Scleral Profile (CSP) is available with the Oculus Pentacam (Oculus, Arlington, Washington). This enables the Pentacam to measure sagittal height, a parameter needed for scleral lens fitting. The images of a CSP scan are taken from the same visual scan without the need for eye movement, according to an Oculus news release. The CSP scan is a tear film independent measurement with automatic release.
  • The Retina Plus and the multifocal electroretinography (mfERG) are now available from Diopsys (Pine Brook, New Jersey). The Retina Plus is an advanced flicker electroretinography system, and the mfERG is for use with the NOVA, ARGOS, or the new Retina Plus platforms, all made by Diopsys.

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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