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Volume 15, Number 5
23 February 2010



RiskMetrics Group questions legality of Novartis' merger proposal to Alcon
RiskMetrics Group, Inc. (Ann Arbor, MI, USA), a risk management and corporate governance firm, has voiced concerns about the adequacy and legality of the merger proposal by Novartis (Basel, Switzerland) to minority shareholders of Alcon (Fort Worth, TX, USA/Hünenberg, Switzerland), Alcon said in a press release.
The questions of legality pertain to any attempt by Novartis to "unilaterally impose a full takeover on Alcon", Alcon said in the release. RiskMetrics also found that the proposal is in breach of best practices for mergers and acquisitions.
The findings of RiskMetrics group largely echoed those of the Alcon Independent Director Committee, which previously concluded that the Novartis proposal is "grossly inadequate", Alcon said in the release.
On 4 January 2010, Novartis announced it would buy Alcon for about US$180 a share from majority shareholder Nestle. Novartis already owned 25% of Alcon; with Nestle's share, Novartis would then own about 77% and planned to buy the remaining 23% for about US$147 a share, the companies reported.
RiskMetrics determined that premiums paid on standard squeeze-out transactions were on average 18.0% and 23.8% above the one-day and four-week target price, respectively, as compared with the Novartis proposal, which offered a discount of 7.0% and 5.0%, respectively. RiskMetrics disputed Novartis' claims that Alcon's stock was trading with takeover speculation. The risk management firm also noted that the price Nestle negotiated for its stake two years ago is "to a large extent irrelevant to minority shareholders", who are now faced with a different price.


Federal government awards nearly US$1B in funds for healthcare IT, job training
Government agencies in the US have awarded a total of nearly US$1 billion in Recovery Act funds to train healthcare providers to better use information technology (IT), as well as to train future healthcare workers, said US Health and Human Services secretary Kathleen Sebelius and labor secretary Hilda Solis in a press release.
These awards will make health IT available to over 100,000 hospitals and primary care physicians by 2014 and will train thousands of people for careers in healthcare and IT. The Recovery Act investment is aimed at strengthening the burgeoning health IT industry, which is expected to support tens of thousands of jobs ranging from nurses and pharmacy techs to IT technicians and trainers.
Over US$750 million in HHS grant awards are part of a federal initiative to foster widespread, meaningful use of healthcare IT, Sebelius said in the release. The assistance at the state and regional level will support healthcare providers' efforts to utilize electronic health records in an efficient and meaningful manner. Of the over US$750 million designated, US$386 million will go to 40 states and qualified state-designated entities to implement health information exchange at a state level, while US$375 million will go to an initial 32 nonprofit organizations to facilitate the development of regional extension centers. Additional awards for health information exchange and regional extension centers are expected to be announced in the near future, Sebelius and Solis said in the release.


VEGF Trap-Eye yields positive DME Phase II data
VEGF Trap-Eye demonstrated a statistically significant improvement in visual acuity over 24 weeks compared with macular laser therapy in patients with diabetic macular edema (DME), said co-developers Regeron Pharmaceuticals (Tarrytown, NY, USA) and Bayer Healthcare (Leverkusen, Germany) in a joint press release.
In this study, visual acuity improvement was assessed by the mean number of letters gained over the initial 24 weeks of the study, the companies said. The double-masked, prospective, randomized, multicenter Phase II trial evaluated 219 patients with clinically significant DME with central macular involvement. The patients were randomized to five groups.
The control group was given macular laser therapy at week one, and these patients were eligible for repeat laser treatments, but these were available in limited frequency of no more than at 16-week intervals. Two groups received monthly doses of 0.5 or 2.0 mg VEGF Trap-Eye throughout the six-month dosing period, and two groups received three initial monthly doses of 2.0 mg of VEGF Trap-Eye (at baseline and weeks 4 and 8) followed through week 24 by either every eight-week dosing or "as needed" dosing with specific repeat dosing parameters. At week 24, the macular laser therapy group (N=44; 1.7 treatments) had gained +2.5 letters; the VEGF Trap-Eye 0.5 mg monthly group (N=44; 5.6 injections) had gained +8.6 letters; the VEGF Trap-Eye 2.0 mg monthly group (N=44; 5.5 injections) gained +11.4 letters; the group receiving VEGF Trap-Eye 2 mg every other month, following three monthly injections (N=42; 3.8 injections) gained +8.5 letters; and the group receiving VEGF Trap-Eye as needed following three monthly injections (N=45; 4.4 injections) gained +10.3 letters.
Regeneron said additional results will be available later this year.


Opko Health acquires Mexican pharma company
Opko Health (Miami, FL, USA) has completed the acquisition of Pharmacos Exakta (Guadalajara, Mexico), a privately held company involved in the manufacture, marketing and distribution of ophthalmic and other types of pharmaceutical products, the company said in a press release. Pharmacos Exakta's products are marketed to government and private entities, the company said in the release.


RESEARCH BRIEFS:
  • Amatadine appears more likely to affect the corneal endothelial cells of Parkinson’s disease patients in a dose-dependent manner when used long-term, according to researchers at Seoul National University College of Medicine. In the cross-sectional study, Ki Cheol Chang, MD, and colleagues evaluated 169 eyes in 169 patients taking oral amatadine for Parkinson’s disease, as well as a control group consisting of the same number of patients and matched for gender and age. The researchers compared endothelial indices between the amatadine group and the control group. The amatadine-treated group was divided into three subgroups based on the cumulative dose and duration of treatment. Endothelial changes were compared between the amatadine group and the control group, and also between the subgroups within the amatadine group. The main outcome measures included slitlamp biomicroscopy, central corneal thickness, endothelial cell density (ECD) coefficient of variation, and hexagonality. The study found that the amatadine group had significantly lower ECD, lower hexagonality, and greater coefficient of variation than the control group. Evaluation of the subgroups showed that longer duration and a higher cumulative dose amatadine treatment yielded a greater reduction in ECD compared with the normal control group. The study was accepted in October 2009 for publication in Ophthalmology.
  • A single triamcinolone injection may be as effective as a three times repeated intravitreal dosage of bevacizumab for the treatment of diabetic macular edema, according to researchers at Ludwig-Maximilians University, Munich, Germany. In the study, Thomas C. Kreutzer, MD, and colleagues looked at a group of 32 patients who had been treated with a single 4.0 mg intravitreal injection of triamcinolone (group 1) and matched this group to 32 patients who had received three injections of 1.25 mg of bevacizumab within three months in four-week intervals (group 2). The researchers evaluated changes in best-corrected visual acuity and central retinal thickness three months after treatment. The groups did not differ regarding pre-op VA and central retinal thickness measured by optical coherence tomography. The researchers found that the patients in group 1 showed a slight increase in VA of an average of 0.7 lines following a single triamcinolone injection after three months, and the patients in group 2 showed almost no effect on VA, with an average increase of 0.2 lines after three intravitreal injections of bevacizumab. There was no statistically significant difference in the effect on VA between the two groups (P=0.115). Regarding central retinal thickness, both groups were found to be very effective (P<0.001 each), and no significant difference was noted between the groups (P<0.128). The study is published in Ophtalmologica.
  • Posterior aberrations and spatial thickness profile data do not appear to markedly improve the ability to detect eyes with subclinical keratoconus compared to anterior wavefront data alone, according to researchers at Goethe University, Frankfurt, Germany. In the study, Jens Bühren, MD, and colleagues evaluated 32 eyes (group 1) of 25 newly diagnosed keratoconus patients, 17 eyes of 17 patients (group 2), which were asymptomatic fellow eyes without clinical signs of KC, and 123 healthy eyes of 63 patients, which served as the negative controls (group 3). The researchers evaluated Zernike coefficients from anterior and posterior surface, data from corneal thickness spatial profiles, and output values of discriminant functions based on wavefront and pachymetry data for their effectiveness in differentiating between the KC group (groups 1 and 2) and the control group (group 3). This was gauged using receiver-operating characteristic (ROC) curve analysis. Vergical coma (C3-1_ from the anterior surface was found to be the coefficient with the highest ability to discriminate between groups 2 and 3. For posterior wavefront coefficients and pachymetry data, AzROC values were lower. AzROC values were increased by constructing Zernike coefficients. The function containing first-surface data achieved an AzROC of 0.993; the functions containing posterior surface or pachymetry data had lower AzROC values (0.932 and 0.903, respectively). The function with anterior, posterior and pachymetry data reached an AzROC of 1.0. The researchers concluded that while corneal wavefront and pachymetry were highly accurate in discriminating the KC eyes from the normal eyes, the posterior aberrations and thickness spatial profile data did significantly improve this detection. The study is published online ahead of print in Investigative Ophthalmology & Visual Science.
  • Although the Ex-PRESS mini glaucoma shunt (Optonol, Kansas City, KS, USA) is affected by magnetic field forces, it appears to be safe for use in magnetic resonance imaging (MRI) of up to 3 Tesla due to resistance provided by the ocular tissue, according to Noa Geffen, MD, and colleagues. They assessed the influence of a magnetic field on the Ex-PRESS glaucoma shunt in four situations: a wet dish test, in which the device was placed floating in a dish filled with water and exposed to magnetic fields of 1.5 and 3 Tesla for 30 seconds; a dry dish test, in which the device was placed in a dry dish and exposed to a magnetic field of 3 Tesla for 30 seconds; an intracameral test, in which the device was permitted to float freely in the anterior chamber of a human cadaver eye and exposed to a magnetic field of 3 Tesla; and a scleral fixation test, in which the device was implanted through the sclera of a human cadaver eye and exposed to a magnetic field of 3 Tesla. The researchers found that during the wet dish test, the Ex-PRESS glaucoma shunt moved immediately across the dish when exposed to both 1.5 and 3 Tesla. No movement was observed in the dry dish test, the intracameral test, or the scleral fixation test. The study is published in the Journal of Glaucoma.
  • Both central visual impairment (CVI) and peripheral visual impairment (PVI) appear to be linked to increased risk for falls and falls with injury four years after the initial examination in a dose-response manner, according to the findings of the Los Angeles Latino Eye Study Group. In the population-based, prospective cohort study, Cecilia M. Patino, MD, and colleagues evaluated a population-based sample of 3,203 adult Latinos. The researchers classified the subjects’ baseline presenting binocular central distance acuity impairments as mild (20/40 to 20/63, or 6/12 to 6/20) or moderate/severe (< 20/80 or 6/24). PVI was categorized as mild (-6 dB < mean deviation < -2 dB in worse eye_ or moderate/severe (mean deviation < -6 dB in worse eye). Falls and falls with injury within the past year were assessed by self report at the four-year follow-up visit. The study found that of the 3,203 individuals studied, 19% reported falls and 10% reported falls with injury four years after the baseline examination; participants with falls were more likely to be >60 years of age, be female, report lower income, have more than two comorbidities, report alcohol use, report wearing bifocal glasses, and report obesity. Among those who reported falls, 7% had CVI (visual acuity > 20/40), compared with 4% who did not report falls; 49% had PVI (mean deviation < -2 dB) compared with 39% of those who did not report falls (both P<0.0001). After adjusting for confounders, moderate to severe CVI and PVI were associated with increased risk for falls and falls with injury. The study is published in Ophthalmology.
NEW PRODUCT BRIEFS:
  • OCuSOFT (Richmond, TX, USA) has launched TetraVisc FORTE, an updated version of its TetraVISC topical anesthetic gel. TetraVisc FORTE is formulated with higher viscosity and increases corneal contact time, the company said. The product is packaged in 5-ml dropper bottles and single unit-of-use 0.6-ml bottles.


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