Allergan to hold stockholders
meeting Dec. 18

Allergan (Irvine, Calif.) will hold the Special Meeting of Stockholders on its originally scheduled date (Dec. 18, 2014), the company said. Pershing Square and Valeant (Laval, Canada) will dismiss their pending litigation as a result, Allergan added.

The United States District Court for the Central District of California has set October 28, 2014 as the hearing date for Allergan's motion for a preliminary injunction against Valeant and Pershing Square for violations of the federal securities laws, including insider trading.

Osmolarity tests confirm
majority has elevated levels

The interim results from the U.K.'s National Health Service Dry Eye Disease (DED) Prevalence Study found elevated tear osmolarity levels in 72.3% of the 596 enrolled patients, indicating an abnormal and unstable tear film, TearLab (San Diego) said in a news release.

Three NHS ophthalmology consultants (Hillingdon Hospital in Middlesex; Great Western Hospital, Swindon, Wiltshire; and St. Peter's Hospital, Chertsey, Surrey) compared the efficacy of conventional dry eye tests (tear break-up, OSDI, meibomian gland dysfunction, and DEWS) to determine if osmolarity could improve the identification of DED patients better than conventional tests.

With interim results completed this past June, the researchers found conventional dry eye tests do not correlate well with the presence of DED and that based on these tests, almost half of all cases may not be identified as having DED. Further, osmolarity has the highest agreement (78%) with the DEWS composite score.

An elevated osmolarity measurement (326.8 mOsm/L average) was the only definitive sign in 20.1% of patients (120 individuals) who had significant symptoms but no other sign of dry eye.

The ongoing study hopes to enroll a total of 1,000 patients and will add another site, TearLab said.

Hyperosmolarity may
impact cataract surgery

During this week's European Society of Cataract & Refractive Surgeons Congress, Doyle Stulting, MD, presented preliminary results evaluating the relationship of a hyperosmolar tear film on keratometry readings (N=67), and said hyperosmolar patients demonstrated a wider variation in keratometry calculations between visits relative to the normal osmolar group. TearLab (San Diego) sponsored the study.

In the hyperosmolar group, 16% of hyperosmolar eyes had more than 1 diopter of change in K cylinder values between the first and second visit.

Eylea designated 'breakthrough
therapy' for DR

The Food and Drug Administration has granted Eylea (aflibercept, Regeneron, Tarrytown, N.Y.) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy (DR) in patients with diabetic macular edema (DME).

The designation is based on positive results in two phase 3 trials (VIVID-DME and VISTA-DME) in which Eylea demonstrated a statistically significant improvement in a pre-specified measure of DR in patients with DME after 2 years of treatment, Regeneron said.

The FDA created the Breakthrough Therapy designation to expedite the development and review of drugs for serious or life-threatening conditions. Drugs qualifying for this designation must show credible evidence of a substantial improvement on a clinically significant endpoint over available therapies, or over placebo if there is no available therapy.

RESEARCH BRIEFS

• Lacritin is significantly reduced in the tears of Sjogren's syndrome (SS) subjects, according to T. Vijmasi and colleagues. Tears from healthy controls (n=14) and SS patients (n=15) were assayed for lacritin using a C-terminal antibody. In a paired-eye study, autoimmune regulator (Aire) knockout (KO) mice (n=7) were treated 3 times daily for 21 days with 10 μL of 4 μM lacritin (left eye) or vehicle (PBS) control (right eye). Lacritin monomer and C-terminal fragment protein per 100 μL of tear eluate were significantly lower in SS patients. In Aire KO mice treated with lacritin, tear secretion increased by 46 and lissamine green staining score significantly decreased relative to baseline. The study is published in Investigative Ophthalmology & Visual Science.
• Dryness, eye pain, redness, blurry vision, and epiphora were the main symptoms in patients with conjunctivochalasis (CCh), according to Ozlem Balci. He retrospectively enrolled 30 subjects (50 eyes) diagnosed with CCh. Complete ophthalmic examination, including visual acuity assessment, slit lamp examination, applanation tonometry, dilated fundoscopy, tear break-up time, Schirmer 1 test, and fluorescein staining were performed in all patients. Ages ranged from 45 to 80 years, with a mean age of 65±10 years. CCh gradings were as follows: 30 (60%) eyes with grade 1 CCh; 15 (30%) eyes with grade 2 CCh; and 5 (10%) eyes with grade 3 CCh. CCh was located in the inferior bulbar conjunctiva in 45 (90%) eyes, and in the remaining 5 (10%) CCh was located in the superior bulbar conjunctiva. Ten patients (33.3%) had no symptoms, and pinguecula was found in 10 patients. Altered tear meniscus was noted in all cases. The mean tear break-up time was 7.6 seconds. The study is published in Clinical Ophthalmology.
• Lifetime outdoor activities may contribute to exfoliation syndrome (XFS), suggests Louis R. Pasquale, MD, and colleagues. Their clinic-based case-control study was conducted in the United States and Israel. It involved XFS cases and control individuals (all ≥60-year-old white individuals) enrolled from 2010 to 2012 (United States: 118 cases and 106 control participants; Israel: 67 cases and 72 control participants). In multivariable analyses, each degree of weighted lifetime average residential latitude away from the equator was associated with 11% increased odds of XFS (P<.001). Furthermore, every hour per week spent outdoors during the summer, averaged over a lifetime, was associated with 4% increased odds of XFS (P=.03). For every 1% of average lifetime summer time between 10 a.m. and 4 p.m. that sunglasses were worn, the odds of XFS decreased by 2% (P<.001) in the United States but not in Israel (P=.92; P for heterogeneity=.005). In the United States, after controlling for important environmental covariates, history of work over water or snow was associated with increased odds of XFS; in Israel, there were too few people with such history for analysis. The authors did not identify an association between brimmed hat wear and XFS (P>.57). The study is published online ahead of print in JAMA Ophthalmology.

NEW PRODUCT BRIEFS

• Carl Zeiss Meditec (Jena, Germany) launched the CT LUCIA IOL featuring a C-loop design. It is made of "glistening-free hydrophobic material" and incorporates ZEISS aspheric aberration correcting optics, the company said. It is available with a fully preloaded injector system.
• Reichert Technologies (Depew, N.Y.) introduced the Xcel 455 Slit Lamp, a "traditional style slit lamp with tower illumination and 5 step magnification," the company said. The Xcel 455 Slit Lamp optics incorporate lenses with "high-efficiency, multi-layer optical coatings that provide bright, even illumination and clear image resolution." The Xcel 455 Slit Lamp is currently available in Canada, Europe, and specific countries in the Middle East, Africa, Latin America, and Southeast Asia. The company plans to introduce the device in the U.S. in late 2014 after regulatory clearance.
• Topcon Medical (Oakland, N.J.) introduced the fully automatic TRC-NW400 Non-Mydriatic Retinal Camera. The camera automatically aligns, centers, focuses, and captures color retinal images without user manipulation, and seamlessly travels from one eye to the other, Topcon said. The TRC-NW400 can be connected to a digital capture system or used as a stand-alone instrument. Images of the anterior segment of the eye can also be obtained with the use of the anterior segment feature, Topcon added.