|
News
Abbott to Acquire AMO
Abbott (Abbott Park, IL) will expand its medical device unit by acquiring Advanced Medical Optics, Inc. (AMO, Santa Ana, CA). Under the terms of the agreement, Abbott will tender an offer by January 26 to purchase all outstanding AMO shares at $22 per share for a total transaction value of approximately $2.8 billion.
The transaction value includes an estimated net debt at the time of closing. According to a joint news release from the companies, Abbott expects this transaction to be neutral to ongoing earnings per share in 2009. The increase in earnings per share is expected to begin in 2010.
Abbott's strategy to position innovative technology in leading markets prompted the company to pursue the acquisition, Scott Stoffel, an Abbott spokesman, said in a telephone interview with Cataract & Refractive Surgery Today. "AMO will strengthen Abbott's diverse medical device business by adding another market leading, multibillion [dollar] business to the company as well as position the company for long-term growth," Mr. Stoffel explained. Abbott does not currently have a line of ophthalmic products.
"Joining forces with Abbott will fortify our position as a global ophthalmic medical device leader and enhance our ability to serve eye care practitioners and patients around the world," Jim Mazzo, Chairman and Chief Executive Officer, AMO, said in the joint news release.
Mr. Mazzo will report to John Capek, Vice President of Medical Devices, Mr. Stoffel told CRSToday. Mr. Capek currently oversees Abbott's medical devices business in the vascular, diabetes, and animal health markets. When the deal is closed, AMO will become an operating division of Abbott, and Mr. Mazzo will be the president of the new business. The name of the business is not yet known.
In addition to expanding its medical device business, Abbott is optimistic that the addition of AMO's already strong, competitive position in the LASIK surgical device market, the cataract surgical device market, and contact lens care industry will bring more balance and diversity.
"AMO's business is not only geographically diverse, but diverse in and of itself, participating in three segments of the large and growing vision care market," Mr. Capek said during the company's Web cast on January 12, 2009. "We expect AMO to be a steady, high-single-digit grower on the top line, and a profitable contributor over our long-range plan. We also expect that Abbott's global presence and distribution capabilities will further improve upon AMO's international growth opportunities, especially in emerging markets."
Abbott plans to retain the management team and organization of AMO. Furthermore, AMO will continue to be based in Santa Ana, Mr. Stoffel said.
Alcon Receives Approval on IOL
The FDA approved the AcrySof IQ Restor IOL +3.0 D (Alcon, Inc., Huenenberg, Switzerland) for cataract surgery in patients with presbyopia.
According to a company news release, clinical trials found that, at 3 months, nearly four times the number of patients achieved 20/20 vision at near, intermediate distance, and distance with the AcrySof IQ Restor IOL +3.0 D compared with those who received the control lens, the AcrySof IQ Restor IOL +4.0 D. More than 95% of patients in the clinical trial who received the AcrySof IQ Restor IOL +3.0 D stated that they would choose to have the lens implanted again.
Study investigator Kerry Solomon, MD, is Professor of Ophthalmology at the Medical University of South Carolina and Medical Director at the Storm Eye Institute in Charleston. "The introduction of this lens allows me to deliver a full range of quality vision for my patients' needs, lifestyles, and personal preferences," he said in the news release. "In my experience, the AcrySof IQ Restor IOL +3.0 D gives my patients a more comfortable reading distance, improved intermediate vision for tasks such as computer work, and excellent distance vision. In addition, the lens does so with the same accurate and predictable outcomes I have come to expect from the AcrySof IQ lens platform."
Multifocal IOL Approved for Near and Distance Vision
The FDA approved the Tecnis Mulitfocal IOL (Advanced Medical Optics, Inc. [AMO], Santa Ana, CA) for the visual correction of aphakia in adult patients with and without presbyopia. According to a company press release, the IOL provides patients with high-quality vision for near, far, and intermediate distance at day or night. Additionally, the Tecnis Multifocal IOL is a pupil-independent, nonapodized fully diffractive aspheric lens designed to correct spherical and chromatic aberrations.
"The Tecnis Multifocal IOL delivers a predictable and consistent full range of vision," said Y. Ralph Chu, MD, Founder and Director of the Chu Vision Institute in Bloomington, Minnesota. "The US clinical study shows that more than 94% of patients function comfortably without glasses for all distances, including intermediate. More importantly, my patients are highly satisfied with the results."
AMO plans to ship the IOL to surgeons early this year.
FDA Approves Cosmetic Application for IOP-Lowering Drug
The FDA has approved Latisse (Allergan, Inc., Irvine, CA), a new formulation of the prostaglandin analogue bimatoprost (Lumigan; Allergan, Inc.), for the treatment of hyoptrichosis of the eyelashes. Allergan developed Latisse to capitalize on bimatoprost's ability to increase the length, thickness, and darkness of eyelashes.
A parallel interventional study showed that 78% (106 of 137) of the patients who applied Latisse to the edge of their upper eyelids for 16 weeks had a 1-point improvement (on a scale of 1 [minimal] to 4 [very marked]) in the appearance of their eyelashes. Only 18% (25 of 141) of those who used a placebo achieved similar results.
Allergan anticipates launching Latisse in the first quarter of this year.
Orphan Drug Designation Granted for Treatment of Corneal Graft Rejection
The FDA has granted EyeGate Pharma (Waltham, MA) an Orphan Drug Designation for its lead clinical compound, EGP-437 (dexamethasone phosphate), for the treatment of corneal graft rejection. According to a company press release, EGP-437 is delivered via the EyeGate II Delivery System.
The EyeGate II Delivery System uses iontophoresis, which occurs when an applied electric field enhances the mobility of molecules through cells and tissues primarily through electrochemical repulsion. The EyeGate II consists of an ocular applicator, a syringe and adapter for transferring the product from the vial to the applicator, a generator that provides a consistent current to the electrode of the applicator, and a return electrode to complete the continuous current circuit.
EyeGate is currently enrolling subjects for two phase 2 clinical studies to test EGP-437 for the treatment of uveitis and dry eye. According to the company, the results from these studies are expected in the first half of 2009. The phase 2 study in uveitis reportedly represents a landmark proof-of-concept study of EGP-437 and the EyeGate II: it is the first US clinical trial under an open Investigational New Drug Application to employ iontophoresis technology to deliver an active compound into the eye.
Patient Payment Program Offers Reduced Rates to Boost LASIK Market
CareCredit, Inc. (Costa Mesa, CA), is offering refractive practices a 24-month, no interest plan at a significantly reduced rate from now through March 31, 2009. CareCredit hopes to stimulate the LASIK market by offering patients an affordable monthly payment plan. The merchant fee has been reduced 50%, from 14.9% to 7.5%. Additionally, to help practices attract more patients and schedule more LASIK procedures, the company is providing free materials, including patient postcards, in-practice displays, and inserts that demonstrate how low the patient's monthly payment may be with CareCredit's plan.
For more information, register at www.carecreditstimulus.com or call (800) 859-9975.
Antiseizure Drug Associated With Irreversible Vision Loss Recommended for Approval
Despite Sabril's (vigabatrin; Ovation Pharmaceuticals, Inc., Deerfield, IL) association with visual field defects, the FDA has granted the drug a Fast Track designation as a monotherapy for infantile spasms and an adjunctive treatment for adults with refractory complex partial seizures. Sabril is reported to cause retinal abnormality in infants and bilateral and concentric peripheral visual field defects in adults and children.
According to a news release, a multinational study of 500 adults and children with refractory partial epilepsy found that vigabatrin induced a peripheral visual field defect in 125 (25%) adults and 75 (15%) children. Among infants, a vigabatrin-induced retinal abnormality was found in 155 (31%). Visual field defects were reportedly observed after a median exposure to vigabatrin of 4.3 years in children and 4.7 years in adults.
Dosing levels and cumulative exposure to the drug are associated with a risk of developing a peripheral visual field defect, which does not resolve once the medication is stopped, according to the FDA's findings.
Vigabatrin is currently approved as an adjunctive therapy for treating refractory complex partial seizures in adults and as monotherapy for infantile spasms in children in 50 countries, including Canada, Mexico, and several nations in Europe.
AcrySof Restor Reportedly Yields Good Near, Distance Contrast Sensitivity
Refractive lens exchange with the implantation of the AcrySof Restor IOL (Alcon Laboratories, Inc., Fort Worth, TX) provided good distance and near contrast sensitivity under photopic and mesopic conditions, according to a report in the Journal of Cataract & Refractive Surgery.1
Lead author of the study, Teresa Ferrer-Blasco, PhD, and colleagues at the University of Valencia, Spain, assessed the in vivo visual performance of the AcrySof Restor SN60D3 multifocal IOL by measuring the monocular contrast sensitivity function before and after refractive lens exchange with bilateral implantation of the lens in 30 noncataractous, hyperopic eyes with presbyopia and no more than 1.00 D of astigmatism. The researchers used the functional acuity contrast test chart to measure distance and near vision under three luminance levels (85.0 cd/m², 5.0 cd/m², and 2.5 cd/m²).
No intraoperative complications and, at 6 months, no postoperative complications were observed. The mean residual spherical equivalent refractive error was 0.21 D ±0.19. The best corrected distance and near visual acuities were comparable to those before surgery. For distance vision, the safety index was 1.02 and the efficacy index was 0.91. For near vision, the values were 1.04 and 1.02, respectively.
Dr. Ferrer-Blasco and colleagues found similar pre- and postoperative contrast sensitivity function values for distance and near vision under all lighting conditions. Contrast sensitivity after refractive lens exchange in photopic conditions was slightly lower than before surgery, but the differences were not statistically significant (P>.1), they reported. At the mesopic levels of 5.0 cd/m² and 2.5 cd/m², contrast sensitivity after refractive lens exchange was generally lower at higher spatial frequencies. This outcome is likely, however, because, "under mesopic conditions, distance contrast sensitivity would be expected to be little affected because of the relatively small diameter of the apodized diffractive zone and the contribution of the purely refractive outer zone," the investigators wrote.1
Although "mesopic contrast sensitivity was reduced at distance and near in relation to that found under photopic conditions, in noncataractous patients the performance was comparable to that before surgery with the natural lens and to that with monofocal IOLs," the investigators concluded.1
MMP-9 Activity Highest in Cortical Cataracts
An observational study found that the activity of matrix metalloproteinase-9 (MMP-9) in lens epithelial cells was highest in eyes with cortical cataract compared with posterior subcapsular and nuclear cataracts.1
Although MMPs have been shown to play important roles in regenerative processes in parts of the eye, some studies suggest that MMPs are associated with cataract and involved in cataract formation.2-4
Investigators at the Iladevi Cataract and IOL Research Centre, Memnagar, Ahmedabad, India, analyzed anterior lens capsule samples from 275 patients. The samples were obtained during phacoemulsification and were processed with a succinylated gelatin assay to determine MMP-9 activity. The samples were grouped based on age and on type of cataract.
Of the 275 patients, 84 had nuclear cataract, 81 had cortical cataract, and 110 had posterior subcapsular cataract. The researchers found a significant difference in the level of MMP-9 activity among the three types of cataract P<.001). The highest MMP-9 activity level in lens epithelial cells occurred in eyes with cortical cataract, followed by posterior subcapsular cataract, and then nuclear.
Patients 49 years of age and younger had statistically significantly less MMP-9 activity than those aged 50 to 59 years P<.01). Patients aged 60 years and older had statistically significantly higher MMP-9 activity than those aged 49 years and younger P<.001). However, the MMP-9 activity was not statistically significantly different between patients aged 50 to 59 years and those aged 60 years and older (P=.288).
"In the present study, we believe that the MMP-9 activity in the cortical cataract might have been the result of misregulation caused by various factors, including prolonged exposure to UV radiation," the investigators wrote. They stated that the marginally high MMP-9 activity levels found in eyes with posterior subcapsular cataracts support findings from a rat model that indicated that transforming growth factor-beta induces the formation of posterior subcapsular cataracts by enhancing the secretion of MMP-2 and MMP-9.5 Minimal MMP-9 activity was detected in nuclear cataracts, they wrote, because "MMP-9 is not as directly involved in the formation of [this type of] cataract; oxidative stress is the major causative agent."
Endothelial Loss Influenced by Phakic IOL's Position
An increased loss of endothelial cellular density is significantly associated with a shorter distance between the edge of an iris-fixated phakic IOL and the corneal endothelium, according to a cross-sectional study in the Journal of Cataract & Refractive Surgery.1
Researchers at the Academic Hospital Maastricht, The Netherlands, used anterior segment optical coherence tomography to measure the distances from the center and the edges of the IOL to the corneal endothelium in 242 eyes with various models of myopic phakic lenses. Endothelial cellular measurements were performed preoperatively and at each follow-up examination.
The mean follow-up period was 34.1 ±24.7 months (range, 3 months to 7 years). The mean distance between the edge of the phakic IOL and the endothelium was 1.37 ±0.22 mm. Although the mean distance was smaller than the safety value of 1.50 mm in 68.6% of the eyes, no eye developed corneal decompensation, the study's authors wrote.
Endothelial cellular density loss steadily increased from 2 to 7 years (1.28% ±8.46% at 2 years, 3.25% ±8.24% at 5 years, and 5.02% ±10.40% at 7 years). Based on linear mixed-model analysis, the investigators predicted a yearly endothelial cellular density loss of 0.98% for a mean edge distance of 1.37 mm, 0.15% for an edge distance of 1.59 mm, and 1.80% for an edge distance of 1.15 mm.
"Our study shows that a shorter distance from the edge of the [phakic] IOL to the endothelium was associated with higher endothelial cell loss," Muriel Doors, MD, the study's lead author, wrote in an e-mail to Cataract & Refractive Surgery Today. "This is particularly important for the long-term safety of iris-fixated [phakic] IOLs, as it is known that the anterior chamber depth decreases with age. Hence, endothelial cell counts and anterior segment imaging are mandatory during long-term follow-up of [phakic] IOLs."
Industry Appointments
Kevin Buehler will become President and Chief Executive Officer of Alcon, Inc. (Huenenberg, Switzerland), effective April 1, 2009, following Cary Rayment's retirement from these positions on March 31, 2009. Mr. Rayment will continue to serve as a director and the (nonexecutive) chairman of the board. Mr. Buehler will also be nominated as a board member, with shareholders voting at the annual general meeting on May 5, 2009. Mr. Buehler is currently Senior Vice President, Global Markets, and Chief Marketing Officer of Alcon Laboratories, Inc. (Fort Worth, TX).
Bausch & Lomb (Rochester, NY) announced that Peter Valenti III will join the company as President, North America, Vision Care. Mr. Valenti was most recently Vice President and General Manager, Surgical Devices (United States), for Covidien (Mansfield, MA), where he led sales and marketing strategy for its $1 billion product portfolio. Before that, he spent 12 years with Johnson & Johnson (New Brunswick, NJ) in the positions of Vice President, Global Strategy, and Vice President, US Marketing, both in Vision Care.
Gerald Cagle, PhD, has been named Chief Operations Officer of Neuroptix Corporation (Acton, MA). Most recently, Dr. Cagle served as Senior Vice President of Research and Development and Chief Scientific Officer of Alcon Laboratories, Inc.
|