EW Weekly, May 9, 2014

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May 9, 2014
Volume 19 , Number 13

Femto LDV Z8 receives CE approval

The Femto LDV Z8 has received CE approval for clear corneal and arcuate incisions, capsulotomy, lens fragmentation and "all previously covered cornea and presbyopia applications," marketer Ziemer Ophthalmic Systems (Port, Switzerland) said in a news release.
This device can "perform more than cataract surgery," as refractive, presbyopic, and therapeutic procedures can all be done with the same model. Using adaptive pulse management (APM), the laser pulse energy can be adapted depending on resection type as well as cataract grade, Ziemer noted. An in-house developed optical coherence tomography is also part of the system.

FDA accepts NDA for dry eye treatment

P-321 Ophthalmic Solution for the treatment of dry eye disease has received acceptance from the U.S. Food and Drug Administration (FDA) under an Investigational New Drug, developer Parion Sciences (Durham, N.C.) said in a news release. Preclinical data that supported this approval was presented in a poster session at the Association for Research in Vision and Ophthalmology conference this week.
The epithelial sodium channel (ENaC) plays a key role in the regulation of tear film fluid, and studies with preclinical models of dry eye disease have demonstrated that by blocking ENaC, the tear film volume is restored, maintaining its protective and lubricating actions on the ocular surface, Parion said. P-321 is "a potent ENaC inhibitor with unique pharmacokinetic and pharmacodynamics characteristics designed for topical ocular administration, metabolic stability and limited systemic exposure," the company said.

Glaucoma drug improves vision in women with IIH

Overweight women of reproductive age with idiopathic intracranial hypertension (IIH) may benefit from acetazolamide, according to a National Institutes of Health statement. Acetazolamide has often been prescribed for IIH, but efficacy had not been well studied until Michael Wall, MD, and colleagues at the University of Iowa enrolled 165 participants, almost all women, with IIH and mild vision loss. The average body mass index (BMI) at enrollment was about 40 (30 or greater is considered obese). Participants were put on a dietary plan to reduce salt and calorie intake, along with a lifestyle modification program to encourage physical activity.

About half the participants were randomly assigned to receive acetazolamide. They were given the drug in increasing doses until they reached their maximally tolerated dosage, or up to 4 grams daily. The other half received a placebo in gradually increasing dosages. All were allowed to take headache medications throughout the trial.

After 6 months, both groups had improved scores on visual field tests, a measure of side or peripheral vision. Those on acetazolamide improved by about twice as much as those on the weight reduction program alone. The drug also helped reduce swelling of the optic nerve. Participants receiving acetazolamide lost more weight than the placebo group during the 6 months (6.5% vs. 3.2%). In addition, the acetazolamide group reported greater improvements in daily function and quality of life. Both groups had a similar reduction in headaches.

Six treatment failures occurred in the placebo group (a substantial worsening of vision that required withdrawal from the trial) and one in the treatment group. Seven people on acetazolamide and 1 on placebo stopped taking medication because of perceived side effects. Three people on placebo were admitted to the hospital, compared to 6 on the drug. All side effects were reversed by stopping the drug or reducing the dosage.

The study was funded by the National Eye Institute. 

High frequency ultrasound can be adapted for posterior segment screening

Commonly used clinical techniques to image the anterior segment of the eye can be adapted to screen the posterior segment of postmortem eyes for preclinical research, according to the Lions Eye Institute for Transplant & Research (LEITR) and the Eye Institute at the University of South Florida (USF).

Postmortem globes procured by LEITR in Tampa, Fla., were enucleated by standard techniques and transported to the USF Eye Institute laboratory in saline soaked gauze moist chamber on ice. Within 12 hours post mortem, the eyes received topical drops of 10% phenylephrine and 1% tropicamide, given in two rounds, 3 minutes apart. Investigators oriented and secured the globes with the corneas facing forward and, using a 32-gauge needle, injected a balanced salt solution into the vitreous cavity through a 4 mm site posterior to the limbus. Optical coherence tomography (OCT) raster line scanning images of the macula were obtained.

The eyes were then reoriented so that the posterior pole was facing forward. A high frequency (40 mHz) ultrasound biomicroscopy (UBM) probe covered with a water-filled ultrasound transducer cover was placed over the back of the eyes to obtain images of the macula and adjacent retina.

Results show the pharmacologic agents increased the pupil diameter an average of 1.87 mm.  OCT imaging of the macula identified much of the anatomy seen in an in vivo scan, although postmortem retinal changes imposed some limitations.

The UBM showed recognizable retinal landmarks in the posterior pole and correlated well with the pathology seen on the OCT images such as the epiretinal membranes causing macular puckering, according to LEITR.

The groups presented their data at this week's Association for Research in Vision and Ophthalmology meeting.

Americans unaware of link between common drugs, light irides, and UV-related ocular disease

A majority of Americans are unaware that taking common drugs and having light-colored eyes can make people more vulnerable to UV exposure, according to the American Academy of Ophthalmology (San Francisco).

In a Harris Poll of more than 2,000 U.S. adults, the AAO reported two major gaps in UV safety knowledge: One-third of adults use medications that may increase photosensitivity, or increased susceptibility to damage from UV rays. However, 49% are unaware or do not believe those medications can cause photosensitivity. These photosensitizing drugs include antibiotics containing tetracycline or fluoroquinolones, some birth control and estrogen pills and certain anti-inflammatory pain relievers, such as ibuprofen and naproxen sodium. Second, 54% of Americans have blue, green, or hazel eyes. Yet only 32% of those with light eyes and 29% of all polled know light eyes are more susceptible to UV damage.

The survey also found that 83% of Americans wear sunglasses, but only half (47%) said they check for a UV protection label before buying them. Only 32% make their children wear UV-blocking sunglasses. 

TearLab's COO appointed to TFOS advisory board

The Tear Film & Ocular Surface Society has appointed Seph Jensen, president and chief operating officer of TearLab (San Diego), to its corporate advisory board, the group announced. 


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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