Sunday, April 10, 2011

LensAR™ Laser System Receives FDA Clearance For Lens Fragmentation And Anterior Capsulotomy In Cataract Surgery


Main Category: Eye Health / Blindness
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
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LensAR, Inc., the leading developer of next-generation laser technology for refractive cataract surgery, announced that the company has received 510(k) clearance from the FDA for use of the LensAR™ Laser System for anterior capsulotomy and lens fragmentation during cataract surgery.

"Receiving the additional FDA indication for lens fragmentation is a significant milestone achievement in getting our technology one step closer to commercialization. We are very pleased with the exceptional fragmentation data that was submitted to obtain the indication and the resulting FDA clearance," said Randy Frey, founder and Chief Executive Officer of LensAR™.

Louis "Skip" Nichamin, MD, went on to comment, "In 2010, I was honored to be the first US surgeon to use the LensAR™ Laser System. I found that even in the most advanced grades of cataract that the lens fragmentation and extraction process was considerably more proficient and seamless than conventional phacoemulsification. The recent FDA clearance is a tremendous accomplishment in advancing innovative technologies that will improve lens replacement surgery."

The LensAR™ Laser System has been developed to meet the advancing needs of refractive cataract surgeons and their patients. The proprietary 3D-CSI™ (Confocal Structured Illumination) imaging and biometry system is being designed to image and analyze the anatomy across all grades of cataract to improve proficiency.

Unlike traditional imaging systems, 3D-CSI™ provides clean, low noise images that are both high contrast and high-resolution from the anterior surface of the cornea to the posterior capsule. The precision of the LensAR™ Laser System creates an exact capsulotomy incision size and placement based on IOL selection and fragments high grade cataracts for easier removal.

The LensAR™ Laser System is cleared by the FDA for anterior capsulotomy and lens fragmentation. The system has been used in more than 500 eyes outside the United States to date. For other indications it is an investigational device limited by US law to investigational use only.

Source:
LensAR, Inc.

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Merck Announces FDA Acceptance Of New Drug Application For Investigational Ophthalmic Medication SAFLUTAN(R) (Tafluprost)


Main Category: Eye Health / Blindness
Also Included In: Regulatory Affairs / Drug Approvals
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Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today that the New Drug Application (NDA) for SAFLUTAN® (tafluprost), Merck's investigational preservative-free prostaglandin analogue ophthalmic solution, has been accepted for standard review by the U.S. Food and Drug Administration (FDA). SAFLUTAN is the proposed trade name for tafluprost in the United States.

Merck submitted an NDA to support the proposed use of SAFLUTAN for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension. SAFLUTAN is believed to help increase the fluid drainage that occurs through the root of the iris in the eye (this fluid is also known as aqueous humor). SAFLUTAN is currently approved in several European countries, including the United Kingdom, Spain and Italy. Additional launches in other countries are expected, pending regulatory approvals.

"Merck has been providing new therapies to help treat eye diseases for more than 50 years," said Joseph Markoff, Ph.D., M.D., global director, Scientific Affairs, Ophthalmology, Merck. "The acceptance of the NDA submission for tafluprost is an important milestone in our effort to bring forward an additional therapeutic option for patients with primary open-angle glaucoma or ocular hypertension."

On April 15, 2009, Merck and Santen Pharmaceutical Co., Ltd. entered into a worldwide licensing agreement for tafluprost. Merck has exclusive commercial rights to tafluprost in Western Europe (excluding Germany), North America, South America, Africa, the Middle East, India and Australia. Santen retains commercial rights to tafluprost in most countries in Eastern Europe, northern Europe and in countries in the Asia Pacific region, including Japan. Santen will have the option to co-promote SAFLUTAN in the United States, if approved.

Source:
Merck

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Dow Corning And The Centre For Vision In The Developing World Launch Children's Vision Correction Initiative


Main Category: Eye Health / Blindness
Also Included In: Pediatrics / Children's Health
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Dow Corning, a global leader in silicon-based technology, and the Centre for Vision in the Developing World (CVDW) are jointly announcing a collaboration to create an innovative new way to help correct the vision of children in the developing world. Dow Corning has committed US $3 million of funding and materials expertise to the CVDW as part of this collaboration to launch an initiative called Child ViSion™.

The Child ViSion™ initiative will design, manufacture and distribute a child-specific version of self-adjustable eyeglasses to children in the developing world. The aim is to increase the effectiveness of classroom-based education by improving children's ability to see the blackboard from which they are being taught.

"There are 100 million children or more in the developing world who need glasses to benefit fully from their education in the classroom. This problem arises principally because there are too few eye care professionals in the developing world," said Prof. Josh Silver, Oxford University physicist, founder and director of the CVDW, and inventor of the world's first universal fluid-filled adjustable eyeglasses. "Through this collaboration with Dow Corning, CVDW can now expand our efforts to provide eyeglasses to the children who need them for their education."

The goal of the CVDW, a United Kingdom-based Community Interest Company, is to improve vision for people in the developing world who lack access to adequate vision correction.

"This collaboration between Dow Corning and the Centre for Vision in the Developing World will combine our expertise to help bring improved vision correction to children in desperate need," said Stephanie A. Burns, Chairman and CEO of Dow Corning.

Through Child ViSion™, Dow Corning will work with the CVDW to explore how self-adjustable eyeglasses can be designed specifically for the needs of children so that the glasses are able to withstand daily use, are light weight and look more appealing, which will increase the likelihood that they will be worn. Another key element of the initiative will be to ensure the design can be scaled up to mass-production levels, which includes lowering the cost of production.

"Dow Corning fluids played a critical role in Prof. Silver's pioneering self-adjustable glasses, which have already provided vision correction to approximately 40,000 people in more than 20 countries," said James Stephenson, Dow Corning global Healthcare marketing manager and leader of the Child ViSion™ initiative at Dow Corning. "We are excited to further our relationship with the CVDW and to see how our silicon-based technologies can now improve vision correction and the quality of life for children in the developing world."

Note

Prof. Silver's original self-adjustable glasses contain special lenses composed of clear membranes that are filled with Dow Corning silicone fluid. By adding or removing fluid via a removable syringe and dial attached to the glasses' frame, wearers can modify the curvature of the lenses and therefore the strength of their glasses. The glasses are designed to provide vision correction for myopia (nearsightedness), hyperopia (farsightedness) and presbyopia (inability to focus on near objects).

Source:
Dow Corning
Centre for Vision in the Developing World

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Saturday, April 9, 2011

Periocular Treatment Improves Eye Comfort And Quality Of Life For Patients With Facial Paralysis


Academic Journal
Main Category: Eye Health / Blindness
Also Included In: Rehabilitation / Physical Therapy
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Patients with facial paralysis who underwent surgical treatment for a condition that leaves them unable to completely close their eyes reported improvement in comfort around the eyes and overall quality of life, according to a report in the March issue of Archives of Facial Plastic Surgery, one of the JAMA/Archives journals.

The inability to close the eye can be a devastating result of facial paralysis. "The resulting loss of corneal protection can lead to exposure keratitis [inflammation of the cornea], corneal ulceration, and potentially permanently vision loss," the authors write as background information in the article. "Eyelid weight placement, lower eyelid suspension, and brow ptosis [drooping or sagging of the eyelid] correction are frequently performed to protect the eye."

Douglas K. Henstrom, M.D., of Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, and colleagues measured and reported the change in quality of life (QOL) after surgical periocular treatment. The researchers used the Facial Clinimetric Evaluation (FaCE) scale - a patient-based system that measures impairment and disability in facial paralysis and represents a valuable adjunct to traditional physician-graded scales for evaluating QOL issues in patients affected by facial paralysis.

From March 2009 to May 2010, 49 patients with paralytic inability to completely close the eye were treated at the Facial Nerve Center at Massachusetts Eye and Ear Infirmary, Boston. Thirty-seven of the patients completed preoperative and postoperative FaCE surveys.

"Overall QOL, measured by the FaCE instrument, significantly improved following static periocular treatment," the authors report. "Mean FaCE scores increased from 44.1 to 52.7."

"Patients also reported a significant decrease in the amount of time their eye felt dry, irritated, or scratchy," the authors write.

Two patients experienced localized cellulitis (a bacterial infection of the skin and tissues beneath the skin) in reaction to the eyelid weight. There was one eyelid weight extrusion.

"In the overall treatment paradigm for patients with facial paralysis, treating the eye using this modality is simple, and not only improves corneal protection but also yields a significant subjective benefit," the authors conclude.

Arch Facial Plast Surg. 2011;13[2]:125-128.

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Glaucoma Week Designed To Raise Awareness Of "Sneak Thief Of Sight"

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Main Category: Eye Health / Blindness
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Often referred to as the sneak thief of sight because it slowly causes vision loss, physicians and researchers at the Eugene and Marilyn Glick Eye Institute are trying to learn if glaucoma could be related to blood flow in the eye. Their discoveries could change treatment options for one of the leading cause of blindness in the U.S.

Glaucoma develops when pressure builds in the eye and causes damage to the optic nerve, explains Louis Cantor, M.D., chairman of the Department of Ophthalmology at the Glick Eye Institute. "The optic nerve is the main cable carrying the messages from the eye to the brain. Damage to the optic nerve can cause blind spots to develop, and those spots often go unnoticed until they increase in size, impairing sight," he said. "The result is vision loss that cannot be recovered."

This week is World Glaucoma Week, dedicated to bringing awareness to the disease. The observance is to raise awareness of the disease, which can occur without symptoms in up to 50 percent of patients who have glaucoma. In the United States, more than 4 million people have glaucoma. African-Americans and Hispanics are more susceptible to the disease although it strikes all races. Risk factors for glaucoma include:

- Age
- Being African-American or Hispanic
- Having a family history of glaucoma
- Having elevated eye pressure
- Being farsighted or nearsighted
- Having previous eye injuries
- Having other health problems such as diabetes, low blood pressure or migraine headaches.

Working with Alon Harris, Ph.D., director of clinical research for the Glick Eye Institute, Dr. Cantor hopes their approach to understanding glaucoma will benefit patients in Indiana and around the world. "In Indiana alone, the number of patients with glaucoma could fill Lucas Oil Stadium," he says. "And there are thousands more who have the disease who don't know it, and they are most at risk for vision loss."

Their study, the Indianapolis Glaucoma Progression Study, is the largest of its kind in the United States. With 120 patients enrolled for three years, the clinical trial is in its second year, and is focused on vascular - or blood flow - causes or effects of the disease. Dr. Harris is principal investigator of the study.

"I hope they learn something that can be applied to problems in the short run," said patient Jim Palmer, an Indianapolis resident. "This study of blood flow might find out that it is just as significant as pressure, and that could be of benefit to all glaucoma patients."

Dr. Harris explains that eye pressure is the most common measurement in glaucoma. But he notes that some patients develop glaucoma and don't experience the high ocular pressure common in other patients, and some of those patients without high pressure lose sight to the disease. The research is important to determine if blood flow plays a part in the disease.

Maybe, he said, some patients don't receive enough blood flow to their eyes. This study will help determine if improper blood flow is a side effect of the disease or a cause of the disease.

"Unlocking the answer to that question could give us different treatment options for glaucoma," Dr. Harris said. "Understanding the role the vascular system plays in the disease would bring a new way of looking at glaucoma patients."

Dr. Harris is an international expert on the field of ocular blood flow and has designed and perfected many of the diagnostic tests performed on the study patients.

"I've learned a fair amount about this disease because of participating in the study," Palmer said. "And they check so many different things that it would be cost-prohibitive to have all of this done if I did not participate in the study."

Palmer, 67, has experienced glaucoma since about 1986. He learned he had the disease when he saw an ophthalmologist for a detached retina. He currently manages his glaucoma with drops he uses three times a day.

Study participant Carolyn Christman also is a long-time glaucoma patient. "I've learned the newest information from the doctors and the fellows and it's been helpful to me to have this information about my glaucoma," she said. The 70-year-old patient has had glaucoma since she was 42.

"This study, working on the relationship between blood pressure and blood vessels around the eye, is interesting to me," she said. "Participating is my way of helping other people."

The opportunity to participate in a study that could determine new treatments also appealed to Ronnie Adams. The retired 70-year-old African-American says glaucoma runs in his family - his father lost vision in one eye due to the disease and his sister, who also has glaucoma, convinced him to have his eyes examined.

"I'd say the study experience has been really good," Adams said. "I don't want to lose my eyesight and right now it looks as if the drops I use are helping. It's important to try to do something to improve the situation or not lose vision."

Cantor and Harris say the participation of their study patients is crucial to their success in formulating new discoveries about glaucoma.

"We rely on our patients to help us understand why this disease strikes when it does," Cantor said. "We're interested in learning if the blood flow theory is one we could explore further and we need our study patients to help us."

Glaucoma is not the only disease that causes vision loss - but vision loss from many conditions can be prevented with proper care. Most people begin to experience changes in their vision as they turn 40, Dr. Cantor said. By age 65, one in three Americans will experience some form of vision-impairing eye disease.

Source:
IU School of Medicine

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FDA Approves UR Technology To Enhance Eyesight

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Main Category: Medical Devices / Diagnostics
Also Included In: Eye Health / Blindness;  Regulatory Affairs / Drug Approvals
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A technology created by University of Rochester physicians and scientists that has helped boost the eyesight of patients to unprecedented levels is now more widely available, thanks to approval by the U.S. Food and Drug Administration.

The technology, called the Rochester Nomogram, marks a leap forward for patients who receive refractive surgery, also broadly known as LASIK. Refractive surgeon Scott MacRae, M.D., helped develop the formula which has helped him achieve nearly unparalleled results in broad groups of patients.

With the aid of the Nomogram, a remarkable 99.3 percent of the eyes that MacRae operates on have vision of 20/20 or better. That's one of the best, if not the best, success rates among refractive surgeons in the world.

This week, a company that has licensed the technology from the University announced that the FDA has approved its use in its refractive surgery system. Technolas Perfect Vision is a cataract and refractive laser company that was formed through a joint venture of Bausch + Lomb and 20/10 Perfect Vision AG. It's currently the only company offering the Nomogram technology in its refractive surgery correction system.

The Nomogram was first created and tested at the University about five years ago by MacRae working together with Manoj Venkiteshwar, Ph.D., who was then a post-doctoral researcher at the University's Center for Visual Science.

MacRae, the director of the Refractive Surgery Center at the Flaum Eye Institute, had long noted that patients undergoing refractive surgery were much more likely to come out of the surgery slightly far-sighted, though their vision was nearly always 20/20 or better. He and Venkiteshwar studied the problem and created a complex formula that helps physicians understand more thoroughly how refractive surgery affects a person's eyesight. The Nomogram adjusts the way a laser interacts with a person's vision, vastly reducing the chances that the patient's eyes will be near-sighted or far-sighted after the procedure.

"We have a commitment to our patients, to do the very best for them that we can," said MacRae. "We've taken an extraordinarily safe, effective procedure and made it even more effective, not only for our patients here in Rochester, but for patients around the world who will have access to this technology."

The FDA approval is the latest development in a nearly 20-year-long project by University scientists and physicians to study and improve human vision.

In the early 1990s, scientist David Williams, Ph.D., director of the Center for Visual Science, began a series of experiments to look into the eye in unprecedented detail, not only to see the organ's fine structures but also to understand how light moves around inside the eye.

His pioneering work opened the door, for the first time in history, to the possibility of fixing not only the three major flaws in the eye that reading glasses and contact lenses have corrected for decades, but also approximately 60 additional imperfections that were never known before. Nearly everyone has these flaws in their eyes to some extent; while most people don't notice them, they hurt our quality of vision in subtle ways.

MacRae, an internationally recognized refractive surgeon, moved to Rochester in 2000 from Portland, Ore., to help bring the developments to the bedsides of patients and give them a quality of eyesight that was not possible before Williams' work. Through a series of clinical trials and work in the laboratory, the Rochester team did just that.

The team helped to create a field known as customized ablation, a form of LASIK that corrects subtle imperfections, bringing about a super-crisp quality of eyesight. Beyond making vision on the order of 20/15 or 20/16 possible or even commonplace in some groups of patients, the technology also increases the eye's ability to see in situations where there is low light or little contrast.

Five years ago, Venkiteshwar and MacRae calculated the subtle effects that customized ablation can have on the eye and how the eye shunts around light. Specifically, they found that fixing subtle imperfections that hadn't even been recognized before Williams' work offered new opportunities for enhancing a person's vision. They developed the Rochester Nomogram to allow surgeons to take advantage of this information during refractive surgery.

"It's not just the formula or the laser used during surgery that makes the difference," said MacRae, who is also professor of Ophthalmology and Visual Science. "Re-shaping the cornea to provide better vision is an incredibly complex process. We've had more than a decade of experience studying the process in great detail, and that very much plays a role in our ability to help our patients see better than they ever have."

Notes:

MacRae is the author of two best-selling books on customized ablation, including Customized Corneal Ablation: The Quest for Supervision. He has trained hundreds of refractive surgeons and has performed refractive surgery on more than 10,000 people during his 25-year career. Recently he was recognized as one of the world's top 50 most influential people in the realm of cataract and refractive surgery by readers of Cataract and Refractive Surgery Today. MacRae also serves as a consultant for Bausch + Lomb.

Source:
Tom Rickey
University of Rochester Medical Center

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