Alcon announced that its board of directors approved a merger agreement with Novartis AG, whereby Novartis will pay a total merger consideration valued at $168 per share for the Alcon shares it does not currently own. “This merger will create a stronger eye-care business with broader commercial reach and enhanced capabilities to develop more new and innovative eye-care products that address unmet clinical needs in eye care,” said Kevin Buehler, Alcon’s president and chief executive officer. “The combination of Alcon’s deep understanding of the eye-care specialty and the broad expertise and scale of Novartis will allow us to address virtually all key areas of eye care with quality products and will position the Alcon business for faster growth.”
Upon completion of the merger, Alcon will become the second largest division within Novartis. CIBA Vision and select Novartis ophthalmic medicines will be integrated into Alcon, forming an organization with more than $8.7 billion in sales. The company expects the merger to: increase commercial capability to accelerate sales growth and support for its customers; expand ability to develop innovative eye-care products that reach the market faster and provide greater patient and market access to advanced technologies; enhance product development and branding opportunities in contact lenses and solutions; and provide cost efficiencies that can be reinvested in research and other growth opportunities.
The merger will be effected under Swiss merger law. Completion is conditional, among other things, on two-thirds approval by the shareholders of both Novartis and Alcon voting at their respective meetings, and the registration and listing of Novartis shares on the Swiss Exchange and New York Stock Exchange.
Acupuncture May Help Some Older Amblyopes
Acupuncture could become an alternative to patching for treating amblyopia in some older children, according to a report in the December Archives of Ophthalmology.
About one-third to one-half of the cases of amblyopia are caused by anisometropia. Correcting these refractive errors with glasses or contact lenses has been shown to be effective in children age 3 to 7 years, but among older children age 7 to 12, only 30 percent respond to visual correction alone.
Patching increases this response rate to two-thirds, but some patients may not comply and those who do may experience emotional problems or reverse amblyopia, the authors note. Jianhao Zhao, MD, of Joint Shantou International Eye Center of Shantou University and Chinese University of Hong Kong, Shantou, China, and colleagues compared acupuncture—which has also been used to treat dry eye and myopia—to patching in a randomized controlled trial involving 88 children.
Of these children, 43 were randomly assigned to the acupuncture group and received five treatments per week targeting five acupoints, or needle insertion sites. The remaining 45 children had their good eye patched for two hours a day and were instructed to do at least one hour of near-vision activities with the lazy eye, such as reading or typing.
After 15 weeks, visual acuity improved by about 1.8 lines in those whose eyes were patched and 2.3 lines in those who had acupuncture. An improvement of two lines or more occurred in 28 (66.7 percent) of those in the patching group and 31 (75.6 percent) of those in the acupuncture group. Lazy eye was considered resolved in 16.7 percent of patched eyes and 41.5 percent of eyes in the acupuncture group.
Both treatments were well-tolerated; children had no problems complying with either therapy, and no serious adverse effects were found in either group. Acupuncture was performed after school to avoid interfering with participants’ studies.
“Although the treatment effect of acupuncture appears promising, the mechanism underlying its success as a treatment for amblyopia remains unclear,” the authors write. Targeting vision-related acupoints may change the activity of the visual cortex, the part of the brain that receives data from the eyes. It may also increase blood flow to the eye and surrounding structures as well as stimulate the generation of compounds that support the growth of retinal nerves, they note.
“The findings from this report indicate that the treatment effect of acupuncture for amblyopia is equivalent to the treatment effect of patching for amblyopia. However, only patients with anisometropic amblyopia were involved in our study and the follow-up period was relatively short,” the authors conclude. “Moreover, acupuncture itself is a very complicated system of therapy. Differences exist among acupuncturists, and there are divergent manipulation modes, stimulation parameters, treatment styles and subjective sensations evoked by acupuncture stimulation. Because of the good results obtained in our study, the acupoints that we used could be considered for use in clinical practice.”
Another Role for Melanopsin
An international collaboration of scientists reports that melanopsin, the light sensor that sets the body’s biological clock, also plays an important role in vision: Via its messengers-so-called melanopsin-expressing retinal ganglion cells, or mRGCs, it forwards information about the brightness of incoming light directly to conventional visual centers in the brain. The report appeared in the Dec. 7 issue of PLoS Biology. These cells could make a significant contribution to assessing the intensity of light and supporting vision even in people with advanced retinal degeneration, the researchers say.
“Millions of people worldwide suffer varying degrees of blindness because of rod and cone degeneration or dysfunction, but many of them can still perceive differences in brightness,” says senior author Satchidananda Panda, PhD, an assistant professor in the Regulatory Biology Laboratory at the Salk Institute for Biological Studies. “Melanopsin-expressing RGCs typically survive even complete rod and cone loss and could explain the light responses under these conditions,” he adds.
For the greater part of 100 years, it was thought that the ability to convert light into electrical signals in the mammalian retina was restricted to rods and cones. This view changed dramatically when Dr. Panda discovered the existence of a third type of mammalian photoreceptor, which is only present in a few thousand cells embedded in the deeper layers of the retina.
Melanopsin, a photopigment that measures the intensity of incoming light, is fundamentally different from the classical rod and cone opsins, which help us see. For one, it is much less sensitive to light and has far less spatial resolution-characteristics that fit perfectly with this light sensor’s primary function of signaling changes in ambient light levels to the brain throughout the day.
It sends its signals directly to the human circadian clock, which sits just above the point where the optic nerves cross. Although only half the size of a pencil eraser, it synchronizes the body’s daily rhythms with the rising and setting of the sun, telling the body when it is time to go to sleep, when to be hungry and when to wake up. But it does more than that. Just like a meter in a camera that allows the aperture to be adjusted, mRGCs also control pupil size.
Until now, however, it was unknown whether mRGCs also contribute to conventional image-forming vision, especially the as-yet poorly understood mechanism of “brightness” and “lightness” perception.
To find out, Dr. Panda and his collaborators at the University of Manchester traced individual mRGCs’ axons—long, slender projections that connect with other neurons—from the retina through the circadian clock and onward. They discovered that the axons reached all the way to the lateral geniculate nucleus, the primary processing center for visual information received from the retina.
“We found widespread light responses in the LGN and visual cortex, even in mice lacking functional rods and cones, which are often used as a model of advanced retinal degeneration,” says Dr. Panda, who hopes that one day it might be possible to impart vision to blind individuals by gene therapy with a re-engineered melanopsin.
“The density of mRGCs in the retina is too low for any meaningful resolution,” he says. “But if we could express melanopsin in a greater number of cells, we might be able to increase resolution to a point that allows blind people to safely navigate their environment.”
FDA Clears Alcon Voluntary Corrective Action Plan
Alcon received clearance from the FDA to complete its voluntary medical device corrective action plan on all Constellation Vision Systems in the United States. Alcon submitted a 510(k) for the action plan to the FDA on May 6, 2010. The plan included specific hardware and software modifications to address identified reported events.
“We are pleased to have received clearance from the FDA and we will now proceed with our plan to upgrade all Constellation Vision Systems,” said Stuart Raetzman, vice president of Global Marketing and area president for the United States. “These modifications have been successful outside the United States and we are confident they will address the identified performance issues and allow our customers to use the Constellation Vision System without any restrictions.”
Alcon established the Accurus Loaner Program to provide support to customers affected by its voluntary corrective action plan. This program allowed doctors to continue providing high-quality vitreoretinal surgery to their patients while Alcon was waiting for the FDA clearance of the modifications. The program provided Accurus Surgical Systems, Purepoint lasers and other needed surgical accessories. Alcon will work as quickly as possible to implement the modifications to existing customer systems and these modifications will be immediately included with all new system installations.
Alcon’s Technical Customer Service team will contact customers to schedule the modifications for the Constellation Vision System.
For assistance and questions, customers may call 1 (800) 561-6466, option 8.