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December 19, 2014
Volume 19, Number 44
Actavis proposes senior team

Actavis (Dublin) announced its planned senior management team following the successful close of the acquisition of Allergan (Irvine, Calif.).

Brent Saunders will continue to lead Actavis as CEO and president and a member of the Board of Directors. Paul Bisaro will remain executive chairman of the Board of Directors. Douglas Ingram, president of Allergan, will continue as a special advisor.

Other key roles: Paul Navarre as executive vice president of Actavis and president of International Brands; William Meury as executive vice president of Actavis and president of Branded Pharma; Philippe Schaison as executive vice president of Actavis and president of Allergan Medical; Robert Stewart as executive vice president of Actavis and president of generics and global operations; Maria Teresa Hilado as executive vice president and chief financial officer; Robert Bailey as executive vice president and chief legal officer and corporate secretary; Karen Ling as executive vice president and chief human resources officer; Charlie Mayr as executive vice president and chief communications officer; Sigurd Kirk as executive vice president and corporate business development; and Jonathan Kellerman as executive vice president and global chief compliance officer.

C. David Nicholson, PhD, will be executive vice president of branded research and development. Alex Kelly and Sanjiv Patel will share the responsibility for pre-integration planning.

Allergan's current CEO, David Pyott, has not yet been offered a role, and all other C-level Allergan executives are not being offered positions.
German authorities: Eylea offers no advantage over Lucentis

The German Institute for Quality and Efficiency in Health Care, a German healthcare cost watchdog group, has concluded Eylea (aflibercept, Regeneron, Tarrytown, N.Y.) "does not offer an advantage" over Lucentis (ranibizumab, Genentech, South San Francisco) in the treatment of diabetic macular edema, according to local reports. These are similar conclusions reached by the group for other eye conditions.

Germany's medical cost-benefit agency plans to publish an assessment of Eylea's cost-effectiveness in March 2015.
New recommendations for vision health

New recommendations that provide "an evidence-based approach to vision screening in children ages 3 through 5" have been published, according to the National Expert Panel (NEP) of the National Center for Children's Vision and Eye Health (NCCVEH) at Prevent Blindness (Chicago).

The mission of the Center "is to develop a coordinated public health infrastructure to promote and ensure a comprehensive, multi-tiered continuum of vision care for young children," Prevent Blindness said. While vision screening "is a great first step to saving vision," that is only one step in the continuum of vision health for children. The current reports include recommended practices for children between 36 and 72 months of age, available at visionsystems.preventblindness.org.
MIT spinoff receives nanoparticle grant

LayerBio, a spin-off of Massachusetts Institute of Technology that develops novel drug delivery products for ophthalmology and wound care applications, has received a $150,000 small business innovation research grant to support development of its nanoparticle-based glaucoma therapy.

LayerBio's drug delivery system is a sustained release of an existing Food and Drug Administration-approved glaucoma drug. It will be delivered through a simple office-based procedure and is expected to last a minimum of 4 to 6 months per dose.
Shire updates R&D plans for 2015

Shire (Dublin) recently updated investors on its research and development pipeline, including SHP607, a protein replacement therapy being developed for the prevention of retinopathy of prematurity (ROP). The therapy recently received fast track designation from the Food and Drug Administration, and is "currently in a phase 2 study to compare the severity of ROP among treatment-experienced patients to an untreated control population matched for gestational age," the company said. Study data is expected during the second half of 2015.

Lifitegrast, the company's dry eye compound, is in a phase 3 study (OPUS-3) to evaluate safety and efficacy with results expected next quarter.

RESEARCH BRIEFS

  • In patients with cataract and corneal astigmatism, bilateral toric IOL implantation results in a higher spectacle independency for distance vision compared with bilateral control IOL implantation, according to Nienke Visser, MD, and colleagues. They compared 86 individuals with bilateral cataract and bilateral corneal astigmatism of at least 1.25 D who were randomized to receive either bilateral toric (n=41) or bilateral aspheric control (n=45) IOL implantation. Preoperatively, mean (SD) corneal astigmatism was 2.02 (0.95) D and 2.00 (0.84) D in the toric and control groups, respectively. Four patients (5%) were lost to follow-up. At 6 months postoperatively, 26 (70%) of the patients in the toric group achieved an uncorrected distance visual acuity of 20/25 or better compared with 14 (31%) in the control group (P<.001). Spectacle independency for distance vision was achieved in 31 patients (84%) in the toric group compared with 14 patients (31%) in the control group (P<.001). The study is published in JAMA Ophthalmology.
  • Deep anterior lamellar keratoplasty (DALK) using the Melles manual technique was effective and safe in restoring corrected distance visual acuity (CDVA) in patients with post-LASIK keratectasia; however, high residual ametropia was a common finding, according to Ramin Salouti, MD, and colleagues. The group retrospectively evaluated patients in an interventional case series to assess the efficacy of DALK for treating post-LASIK keratectasia. The cohort comprised 20 eyes of 18 patients (72% women) with a mean age of 29 years ± 4 (SD). The mean follow-up was 31.8±17.0 months. The mean Snellen CDVA improved significantly from 20/191 before DALK to 20/23 after DALK (P<.001). The mean of the modulus of spherical equivalent refraction was 11.9±6.6 D and 11.4±4.3 D, respectively. The mean K value was 52.2±7.0 D before DALK and 46.0±1.9 D after DALK (P=.001); the mean apical K value, 59.5±5.1 D and 49.9±2.8 D, respectively (P<.001); and the mean keratometric astigmatism, 4.3±2.4 D and 1.9±1.2 D, respectively (P=.003). The endothelial cell profile did not change significantly, and no major complications related to DALK occurred. Twelve eyes had additional refractive procedures to correct residual ametropia. The study is published in the Journal of Cataract & Refractive Surgery.
  • Considering the chronic course of graft versus host disease (GVHD), long-term maintenance treatment with tacrolimus ointment could be useful and safe to locally treat ocular surface inflammation in chronic cases, according to a new study. Ji Won Jung and colleagues retrospectively analyzed the long-term maintenance treatment (≥6 months) with topical 0.02% tacrolimus ointment in patients with chronic ocular GVHD with ocular surface inflammation (at least grade 2 inflammatory score). A total of 13 patients (24 eyes) were treated with tacrolimus ointment for up to 20 months (average 12.2 months). The ocular surface inflammatory score decreased from 2.8 to 0.6 (P=0.001) within 2-8 weeks after starting tacrolimus ointment treatment. The numbers of inflammatory aggravation and the need for steroid treatment also decreased after initiating tacrolimus treatment. At the final follow-up, all patients reported improvement in clinical outcomes, compared to initial findings. Except for blurred vision or mild burning sensation, there were no reported side effects. The study is published online ahead of print in the American Journal of Ophthalmology.

 

NEW PRODUCT BRIEFS

  • VSY Biotechnology introduced its Reviol Tri-ED IOL, a hydrophobic acrylic trifocal IOL with enhanced depth of vision, the company said in a news release. The IOL's "innovative zone establishment displays excellent modular transfer function values even between the intermediate zones," VSY said. The lens combines 3.0 D of near add with 1.5 D of intermediate add and power ranges from 0.0 D to +32.0 D in 0.5 D increments. The IOL has a CE mark, and is commercially available in Germany, Belgium, Czech Republic, Thailand, Japan, and the Philippines. The lens has recently been introduced in the Netherlands, Italy, Azerbaijan, South Africa, and Pakistan. 


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: David F. Chang, MD, chief medical editor; Bonnie An Henderson, MD, cataract editor; Clara C. Chan, MD, cornea editor; Reay H. Brown, MD, glaucoma editor; Kerry D. Solomon, MD, refractive editor; and John A. Vukich, MD, international editor

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