EW Weekly, May 23, 2014

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May 23, 2014
Volume 19 , Number 15

Valeant to host shareholder meeting on Allergan bid

Valeant (Laval, Canada) will meet with shareholders next week to respond to assertions made by Allergan (Irvine, Calif.) listing several reasons why Valeant's business model is unsustainable and not in the best interest of Allergan stockholders, Valeant said in a news release. Valeant is expected to improve its offer for Allergan at that meeting as well, and noted it would not be an all-cash deal.

Shire will file NDA for dye eye drug

Shire (Dublin) will submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first quarter of 2015, the company said in a news release.

Lifitegrast is an investigational treatment that has been studied in a large clinical development program of more than 1,800 patients. The compound, a small-molecule integrin antagonist, was designed to treat dry eye disease, and is a preservative-free topical eye solution. Lifitegrast is believed to work by reducing inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation and cytokine (protein) release. The interaction between these two proteins plays a key role in the chronic inflammation associated with dry eye. T-cells are important components of the immune system that help control the body's response to a foreign or harmful substance or stimuli.

The company is forming an Ophthalmic Business Unit to support commercialization of lifitegrast and to oversee the phase 2 retinopathy of prematurity clinical development programs, led by former Bausch + Lomb executives.

Viral conjunctivitis drug completes phase 2b study enrollment

Auriclosene (NVC-422) Ophthalmic Solution has completed patient enrollment in a phase 2b study as a treatment for adenoviral conjunctivitis, developer NovaBay (Emeryville, Calif.) said in a news release.

BAYnovation is a multi-centered, randomized clinical study that has enrolled patients with adenoviral conjunctivitis in the United States, India, Sri Lanka, and Brazil. Patients were enrolled into the study by 54 clinical investigators, including 18 in the U.S., 19 in India, 6 in Sri Lanka, and 11 in Brazil. Results are expected mid-2014, NovaBay said.

At present, there is no approved medication to treat adenoviral conjunctivitis. 

FDA panel revisits CL care guidelines

The U.S. Food and Drug Administration's Ophthalmic Devices Panel of the Medical Devices Advisory Committee met last week to discuss revising a 1994 guidance document on daily wear contact lenses and a 1997 guidance document for contact lens care products, according to the American Optometric Association.

The deliberations are a result of the nationwide keratitis outbreaks in 2006 and 2007 that led to the voluntary recall of several multipurpose contact lens solutions. Published reports after the panel meeting suggested the FDA does not believe industry should be held responsible for consumer noncompliance with regard to contact lens solution use. Another area of deliberation concentrated on the use of tap water to wash lenses before reinsertion into the eye, specifically in cases of rigid gas-permeable lenses.

HelpMeSee expands cataract elimination program to additional 23 countries

HelpMeSee (New York) has expanded its cataract elimination campaign throughout 23 countries in Western (Francophone) and Sub-Saharan Africa countries through a new partnership that introduces the use of single-use, pre-sterilized manual small incision cataract surgery (MSICS) kits, the group said. The expansion campaign continues driving the reality that the backlog of cataract blindness can be eliminated within the next 20 years.

The single-use kit overcame the issues of sterilization, the group said. With the MSICS Simulator and related courseware/learning resources, HelpMeSee expects to train 30,000 MSICS specialists to help eliminate the backlog of cataract patients.

HelpMeSee will host a kickoff campaign next week in New York City; interested parties can RSVP using the following online invitation: helpmeseewestafric.celebrations.com/tickets.

Orbis launches first program in Eastern Indonesia

Orbis' Flying Eye Hospital (FEH) has landed for the first time in Makassar, Eastern Indonesia, to conduct an intensive and comprehensive training and skills exchange program. The program represents an expansion of Orbis (New York) programing beyond the main island of Java and will focus on providing subspecialty training in the areas of cataract, glaucoma, medical and surgical retina as well as pediatric ophthalmology.

RESEARCH BRIEFS

  • Diode transscleral cyclophotocoagulation in both micropulse and continuous modes was effective in lowering intraocular pressure (IOP), according to M.C. Aquino and colleagues. They randomized 48 patients with refractory, end-stage glaucoma to either treatment; follow-up was 18 months. The main outcome measure was IOP between 6 and 21 mmHg and at least a 30% reduction with or without anti-glaucoma medications. A successful primary outcome was achieved in 75% of patients who underwent micropulse cyclophotocoagulation and 29% of patients who received continuous wave cyclophotocoagulation after 12 months (p<0.01). At 18 months, successful outcome was 52% and 30% (P=0.13), respectively. The mean intraocular pressure was reduced by 45% in both groups (P=0.70) from a baseline of 36.5 mmHg and 35.0 mmHg (P=0.50) after 17.5±1.6 months of follow-up. No significant difference in retreatment rates or number of IOP-lowering medications was noted. The ocular complication rate was higher in continuous wave treated eyes (P=0.01). The study is published online ahead of print in Clinical and Experimental Ophthalmology.
  • Multifocal IOL explantation may be required in some patients undergoing multifocal IOL implantation, but IOL exchange surgery appears to be a feasible surgical option for dissatisfied patients with persistent visual symptoms after multifocal IOL implantation, a group of Japanese researchers found. Kazutaka Kamiya, MD, and colleagues on behalf of the Survey Working Group of the Japanese Society of Cataract and Refractive Surgery evaluated 50 eyes of 37 patients who underwent multifocal IOL explantation followed by IOL implantation. The most common complaints for IOL explantation were waxy vision, followed by glare and halos, blurred vision at far, dysphotopsia, blurred vision at near, and blurred vision at intermediate. The most common reasons for IOL explantation were decreased contrast sensitivity, followed by photic phenomenon, unknown origin including neuroadaptation failure, incorrect IOL power, preoperative excessive expectation, IOL dislocation/decentration, and anisometropia. The axial length was 25.13±1.83 mm. Of the explanted multifocal IOLs, 84% were diffractive and 16% were refractive. Monofocal IOLs accounted for 90% of the exchanged IOLs. Patient satisfaction was significantly improved from 1.22±0.55 preoperatively to 3.78±0.97 postoperatively, which was graded on a scale of 1 (very dissatisfied) to 5 (very satisfied) (Wilcoxon sign-rank test, P<0.001). The study is in press for the American Journal of Ophthalmology.
  • Vision loss from central retinal artery occlusion occurred after cosmetic facial enhancement, and was irreversible in 3 patients, with another patient experiencing a "small amount of recovery" with aggressive therapy, according to a small case series. M. V. Carle and colleagues reported on the off-label use of cosmetic facial fillers in the forehead, where the filler presumably entered the central retinal artery via the rich external-internal carotid anastomoses and became embedded in the retinal tissues, potentially leading to irreversible and severe vision loss. They added this possible adverse reaction is "not typically mentioned" to patients. The article is published online ahead of print in JAMA Ophthalmology.

NEW PRODUCT BRIEFS

  • Industrial Vision Corporation (St. Louis) introduced a Computer Vision program that "goes beyond ergonomics and includes an on-site analysis with a skilled vision professional. They will access each and every work station for computer vision syndrome-related issues to include a workplace assessment, job functionality and vision alignment to improve lighting, seating distance, and overall visual acuity."

EYEWORLD WEEK Online is edited by Stacy Majewicz and Michelle Dalton.

EyeWorld Week Online (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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