Eye Care Medical Blog

AcuMEMS, Inc. announced the development of a new sensor for wireless intraocular pressure (IOP) monitoring of patients with co-incident cataract and glaucoma. Successful animal studies confirm the precise delivery of the implantable pressure sensor into the eye where synthetic intraocular lenses (IOL) are inserted for cataract treatment.

The new sensor expands AcuMEMS’s product line directly into the area of cataract surgery. It is designed for simple implantation during IOL surgery through an un-enlarged phaco/IOL incision, similar to the capsular tension ring procedure.

“IOP is still the best predictor of glaucoma progression we have, as well as the only proven treatable parameter. Today, we clearly could use more accurate IOP data, which should help us protect our patient’s vision,” commented Dr. Andrew Iwach, an ophthalmologist specializing in glaucoma and Executive Director of the Glaucoma Center of San Francisco. Dr. Iwach added, “Implantation of this new technology during cataract surgery offers an ideal opportunity since there should be minimal additional surgical risk yet tremendous potential benefit.”

Douglas Lee, AcuMEMS’ Chairman and CEO, said, “This extension of our proprietary MEMS and wireless technology creates a second and very large market opportunity for AcuMEMS. We estimate that 3,600,000 times each year eye surgeons worldwide must decide how to treat a patient with combined cataract and glaucoma.”

Cataract surgery is considered one of the most popular and highly successful procedures. Each year there are approximately 3 million cataract operations in the United States and 15 million outside the United States. Approximately 20% of patients with cataract are also visually impaired with glaucoma.

Source:

AcuMEMS, Inc.

In a research presentation
at the American Academy of Ophthalmology’s Annual Meeting, Massimo Busin,
MD, department head and professor of ophthalmology at the Villa Serena
Hospital, Forli, Italy, described a technique that significantly improved
results in patients being treated for endothelial disease of the cornea,
the transparent covering of the front of the eye that provides much of its
optical power. When the cell density in the endothelial layer is reduced
below a level compatible with its normal function, the cornea swells and
becomes less transparent, and vision is impaired.

Since endothelial cells do not regenerate, the disease is treated by
transplanting healthy donor tissue. The standard approach has been complete
cornea transplantation (PK, or penetrating keratoplasy). Today, DSAEK
(descemet-stripping automated endothelial keratoplasy)—where only
endothelial tissue attached to a thin layer of deep stroma is transplanted
and the normal structure of the recipient cornea is not disrupted–is
increasingly preferred by corneal surgeons. Most patients receiving DSAEK
recover good vision within weeks (versus six months to a year with PK), and
the risk of complications during and after surgery is minimized. A
significant drawback of DSAEK, though, has been the limited survival of the
transplanted endothelium, with a reduction of up to 50 % of preoperative
density as early as six months after DSAEK.

Dr. Busin described a modified DSAEK technique developed by his group
that resulted in rates of donor endothelial cells survival equivalent to
PK.

“Our approach reduced the rate of endothelial cell loss in the
transplanted tissue to an average of 23% at one year post-surgery, which is
similar to values recorded after PK,” said Dr. Busin. “Our ‘pull through’
technique simplifies the DSAEK procedure and, more importantly, resolves
the main obstacle that has delayed corneal surgeons’ transition to DSAEK.”

About the American Academy of Ophthalmology

AAO is the world’s largest association of eye physicians and
surgeons-Eye M.D.s-with more than 27,000 members worldwide. Eye health care
is provided by the three “O’s” – opticians, optometrists and
ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it
all: eye diseases and injuries, and perform eye surgery. For more
information, visit the Academy’s Web site at aao.

American Academy of Ophthalmology
aao

The American Optometric Association (AOA), the voice for more than 36,000 frontline providers of eye and vision care nationwide, formed a new partnership today with the National Association of School Nurses (NASN) aimed at developing and implementing strategies to ensure that school-aged children have increased access to comprehensive vision care.

In a joint Memorandum of Understanding (MOU) signed by AOA Executive Director, Barry Barresi, OD, PhD, and NASN Executive Director, Amy Garcia, RN, MSN, the two national organizations pledged to develop and implement programs that will increase the level of awareness, understanding, and appreciation for the importance of eye and vision health to the education and overall physical, mental, and social well-being of America’s school-aged children.

According to the National Parent Teacher Association, ten million children suffer from vision disorders. Vision disorders are considered one of the most common disabilities in the United States, and they are one of the most prevalent handicapping conditions in childhood. Undetected and untreated vision deficiencies, particularly in children, can take a large toll. Studies have shown that the costs associated with adult vision problems in the U.S. are at $51.4 billion

“Experts believe that more than 80 percent of what children learn in their early school years is visual. Providing improved access to comprehensive vision care will better equip America’s children with the tools they need to succeed in school and later in life,” said Peter H. Kehoe, OD, AOA President. “As our nation’s school nurses carry out their important mission of coordinating and monitoring the health and well-being of America’s school-aged children, doctors of optometry will be increasingly committed to help ensure that no child is left behind due to an undiagnosed or untreated vision problem.”

The MOU is the latest in a series of relationship-building projects between the AOA and the NASN. In June the AOA House of Delegates passed a resolution calling for increased recognition and support for school nurses. In addition to the MOU signing, AOA’s Dr. Barresi presented a plaque of the school nurse resolution passed by the AOA House of Delegates in June to the NASN delegation at the AOA Washington office on December 4.

America’s school nurses provide triage and referral of many primary eye and vision care conditions to the nation’s doctors of optometry, including strabismus, retinoblastoma, and other serious and potentially blinding problems that can lead to poor school performance and other issues that can ultimately affect quality of life. While amblyopia is treatable and preventable if caught within the early years of a child’s life, it remains the leading cause of vision loss in Americans under age 4.

About the American Optometric Association (AOA)

The American Optometric Association represents approximately 36,000 doctors of optometry, optometry students and paraoptometric assistants and technicians. Optometrists serve patients in nearly 6,500 communities across the country, and in 3,500 of those communities are the only eye doctors. Doctors of optometry provide two-thirds of all primary eye care in the United States.

American Optometric Association doctors of optometry are highly qualified, trained doctors on the frontline of eye and vision care who examine, diagnose, treat and manage diseases and disorders of the eye. In addition to providing eye and vision care, optometrists play a major role in a patient’s overall health and well-being by detecting systemic diseases such as diabetes and hypertension.

Prior to optometry school, optometrists typically complete four years of undergraduate study, culminating in a bachelor’s degree. Required undergraduate coursework for pre-optometry students is extensive and covers a wide variety of advanced health, science and mathematics. Optometry school consists of four years of post-graduate, doctoral study concentrating on both the eye and systemic health. In addition to their formal training, doctors of optometry must undergo annual continuing education to stay current on the latest standards of care.

American Optometric Association

One year post-surgery, patients who underwent Descemet’s stripping automated endothelial keratoplasty (DSAEK) experienced greater cell loss overall compared to those who underwent penetrating keratoplasty (PKP), according to a new analysis of data collected from the Cornea Donor Study (CDS) Investigator Group’s 2008 Specular Microscopy Ancillary Study (SMAS). However, the study, published in the March issue of Ophthalmology, showed that cell loss in DSAEK patients plateaued more quickly than in those who underwent PKP. The two procedures are alternative methods of corneal transplant surgery for diseases affecting the back cell layer of the cornea, the endothelium.

Both the operation and recovery time associated with DSAEK are shorter because the 360-degree PKP wound is larger, weaker and more prone to rupture. PKP, a procedure that has been actively performed for more than 50 years, involves replacing all the layers of the cornea with healthy donor tissue. DSAEK is a newer procedure, developed within the last five years, by which the diseased, endothelium – a layer of cells that maintains the cornea’s clarity and thinness – is replaced with a piece of only healthy donor endothelial tissue. “There is no question of the immediate benefits of DSAEK,” says senior author of the study Jonathan H. Lass, M.D., Professor and Chair of the Department of Ophthalmology and Visual Sciences at Case Western Reserve University School of Medicine and University Hospitals Eye Institute. These benefits include greater eye integrity due to a smaller wound; quicker recovery with less visual distortion; and decreased severity in postoperative surface problems, such as dry eye.

According to Dr. Lass, the present study suggests the potential long-term benefits of DSAEK may outweigh the initial cell loss. “The fact that the transplants are less susceptible to trauma is promising for this growing procedure. DSAEK patients are seeing more quickly than PKP patients and this data suggests that long term they may do better too,” says Dr. Lass. The study’s authors hypothesize that the greater initial cell loss associated with DSAEK is due to greater surgical manipulation of the donated graft itself.

“Demand for DSAEK has grown rapidly because patients appreciate the faster visual recovery with fewer activity restrictions. The greater early cell loss seen with DSAEK initially caused some concern about long-term graft survival, but the results of this study, together with what we’ve learned from continued follow up of DSAEK pioneers treated over five years ago, have helped allay those fears,” says Marianne Price, Ph.D., lead author of the study and Executive Director, Cornea Research Foundation of America.

DSEAK and PKP are both used to manage when the cornea swells due to Fuchs’ dystrophy and pseudophakic/aphakic corneal edema, both conditions affecting the function of the corneal endothelium. The study also found that patients who underwent PKP to correct Fuchs’ dystrophy could expect significantly less cell loss 12 months after the surgery than PKP recipients suffering from pseudophakic/aphakic corneal edema. DSAEK, on the other hand, resulted in similar cell loss after one year for these two diagnoses. The study concludes that long-term follow-up with DSAEK patients will be needed to determine whether differences similar to those experienced by PKP recipients will emerge over time.

Francis W. Price, M.D., and Mark S. Gorovoy, M.D., co-authors of the study, have been leaders in the field of DSAEK surgery since its inception. Dr. Gorovoy says, “As I’ve seen in my patients six years out, the stabilization of endothelial cell loss mitigates the surgical trauma and promotes continued graft clarity. It’s reassuring to have confirmation from the data that the continued clinical success of these patients supports the significant benefits of DSAEK over PKP in the long term management of patients with corneal endothelial failure.”

Funding for this study was provided to Case Western Reserve University School of Medicine by the National Eye Institute.

Source:
Jessica Studeny
Case Western Reserve University

A first-time finding of intraocular pressure increases in patients with no personal or family history of glaucoma following anti-VEGF treatment for wet age-related macular degeneration (AMD) , and a report on a simple, low-cost method that could revolutionize vision screening and treatment in developing countries, are highlights of today’s Scientific Program of the 2009 Joint Meeting of the American Academy of Ophthalmology (AAO) and the Pan-American Association of Ophthalmology (PAAO).

The AAO-PAAO meeting is in session Oct. 24 through 27 at the Moscone Center, San Francisco, Calif. As the largest, most comprehensive ophthalmic education conference in the world, it offers United States and international Eye M.D.s more than 2,000 scientifically-based, peer-reviewed presentations including instruction courses, skills labs, “Breakfast with the Experts” roundtables and 900 research papers and posters.

Wet Macular Degeneration Treatment May Increase Intraocular Pressure

Some patients with age-related macular degeneration (AMD) develop elevated pressure within the eye (intraocular pressure, IOP) following treatment with anti-VEGF medications bevacizumab and/or ranibizumab, reports a Yale University School of Medicine study led by Ron A. Adelman, MD, MPH. Both of these anti-VEGFs control the abnormal growth of blood vessels in the eye’s retina and are very effective against wet AMD, which can result in vision loss or blindness if untreated. But high IOP is a key factor in glaucoma, also a potentially blinding disease. Of 116 Yale study patients treated for wet AMD with either or both medications from 2006 to 2008, 3.45 percent (four patients) developed a significant and persistent rise in IOP.

“To our knowledge, ours is the first study to document persistent ocular hypertension (OHT) following intravitreal bevacizumab injections in patients with no personal or family history of glaucoma or ocular hypertension (OHT),” Dr. Adelman said. “We found that sustained, high IOP may occur after only one anti-VEGF injection, but more typically after multiple injections. Patients’ OHT may continue over several AMD treatments and may require IOP-lowering therapy,” he added.

The researchers also reviewed a report by S.F. Bakri and colleagues on persistent OHT after ranibizumab treatment. Of eight OHT patients total in the two studies, four had received a YAG posterior capsulotomy (a procedure related to cataract surgery) prior to wet AMD treatment, which might have predisposed them to OHT, Dr. Adelman said.

New Screening Method Could Mean Clear Vision for Millions

More than 150 million people globally – particularly in developing countries – struggle with poor vision because they cannot access appropriate eyeglasses. Earlier studies indicated that many could not meet the 20/60 vision driver’s license standard, a level of impairment that makes daily tasks and economic success difficult. Seeking a low-cost solution, Thomas S. Shane, MD, Bascom Palmer Eye Institute, University of Miami, developed a method that uses a new electronic device called an auto-refractor, a vision chart, and pre-made eyeglasses.

Dr. Shane tested this method in high-poverty Mayan villages in southern Belize. Local health workers recruited people, and everyone over age 12 who came to the clinic within a five-day period was tested. In less than a minute per patient the auto-refractor assessed vision and reported the patient’s lens prescription. Of 385 villagers screened 79 needed eyeglasses. Each person received new, pre-made eyeglasses with the appropriate lens strengths; then vision was tested again. On average, vision improved from 20/60 without glasses to 20/25 with glasses.

“This method requires minimal health care worker training and treatment time per patient,” Dr. Shane said. “Costs are further minimized because eyeglasses with a range of lens prescriptions to treat the most common refractive errors could be produced and shipped in bulk. Compared to current practices in developing countries, our method may be much more effective, especially where the need is great but resources are limited.”

Source
American Academy of Ophthalmology

Allergan, Inc. (NYSE:AGN) announced that the U.S. Food and Drug Administration has approved COMBIGAN™ (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor, for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. COMBIGAN™ is the newest addition to Allergan’s comprehensive glaucoma portfolio, which also includes LUMIGAN® (bimatoprost ophthalmic solution) 0.03% and ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% and 0.15%.

“COMBIGAN™ ophthalmic solution is a medication that provides well documented safety and efficacy for patients with inadequately controlled IOP,” said Scott Whitcup, M.D., Allergan’s Executive Vice President, Research and Development. “The development of COMBIGAN™, which has included five key clinical studies, underscores Allergan’s commitment to provide new treatment options for patients with glaucoma.”

COMBIGAN™ is a prescription eye drop that works in two ways to reduce elevated IOP and will be available to physicians in the fourth quarter of 2007. Elevated IOP is a leading risk factor for glaucoma, and the only risk factor that can currently be treated.

“There is no cure for glaucoma; however, lowering elevated IOP can slow the progression of the disease and help prevent further vision loss,” said E. Randy Craven, M.D., Director of Glaucoma Consultants of Colorado and Associate Clinical Professor of Ophthalmology, University of Colorado School of Medicine. “Many patients require more than one medication to meet their target IOP. With COMBIGAN™, it is exciting to be able to offer patients two strong agents in one bottle.”

In the 12-month pivotal trials, COMBIGAN™ significantly reduced mean IOP up to 7.6 mm Hg from baseline and was well tolerated.1 Clinical studies found that COMBIGAN™ ophthalmic solution provided an additional IOP lowering versus either brimonidine or timolol, the two agents included in the formulation of COMBIGAN™, used alone. COMBIGAN™ administered twice a day provided an additional 1 to 3 mm Hg decrease in IOP over brimonidine treatment three times a day and an additional 1 to 2 mm Hg decrease over timolol treatment twice a day. The IOP-lowering of COMBIGAN™ ophthalmic solution dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution 0.2% dosed three times per day.2

About Glaucoma

Glaucoma, a group of eye diseases characterized by damage to the optic nerve, is a leading cause of preventable blindness in the United States.3 It is estimated that more than three million Americans have glaucoma, but only half of those know they have it.4 The total number of glaucoma cases worldwide is estimated to be 65 million.4 One of the risk factors of glaucoma is elevated IOP, or pressure inside the eye. A healthy eye produces fluids, called aqueous humor, at the same rate fluids are drained. If the aqueous humor is not removed rapidly enough or too rapidly, pressure builds up in the eye, which can result in glaucoma. This high pressure distorts the shape and damages the optic nerve. Maintaining healthy IOP levels may slow the progression of the disease and help prevent loss of vision.

Important Safety Information:

Contraindications: COMBIGAN™ ophthalmic solution is contraindicated in patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease; in patients with sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock; and in patients with hypersensitivity to any component of this product.

Warnings and Precautions: Severe respiratory reactions including death due to bronchospasm in patients with asthma have been reported following systemic or ophthalmic administration of timolol maleate. Sympathetic stimulation may be essential in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe cardiac failure. In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease should, in general, not receive beta-blocking agents, including COMBIGAN™. COMBIGAN™ may potentiate syndromes associated with vascular insufficiency. While taking beta-blockers, patients may be more reactive to allergens. Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms. Beta-adrenergic receptor blocking agents may mask hypoglycemic symptoms in patients with diabetes mellitus. Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.

Adverse reactions: The most common adverse reactions occurring in approximately 5 to 15 percent of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, and ocular burning and stinging.

About Allergan, Inc.

With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention, urologics and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients’ lives.

Forward-Looking Statements

This press release contains “forward-looking statements”, including the statements by Dr. Whitcup and Dr. Craven and other statements regarding research and development outcomes, efficacy, market and product potential and other statements regarding COMBIGAN™. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan’s expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product formulation; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan’s public periodic filings with the Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in Allergan’s 2006 Form 10-K and Allergan’s Form 10-Q for the quarter ended June 29, 2007. Copies of Allergan’s press releases and additional information about Allergan is available on the World Wide Web at allergan.

1 Sherwood MB, Craven ER, Chou C, et al. Twice-daily 0.2% brimonidine-0.5%/timolol fixed-combination therapy vs monotherapy with timolol or brimonidine in patients with glaucoma and ocular hypertension: a 12-month randomized trial. Arch Ophthalmol. 2006; 124(9): 1230-1238.

2 COMBIGAN™ prescribing information.

3 Eyecare America; The Foundation of the American Academy of Ophthalmology. “Facts About Blindness and Eye Health.” Available here. Accessed October 30, 2007.

4 Glaucoma Research Foundation. “Glaucoma Facts and Stats” Available here. Accessed October 16, 2007.

allergan

View drug information on Alphagan; Lumigan.

Advanced Medical Optics, Inc. (AMO) (NYSE:EYE), the global leader in advanced refractive technologies for eye care professionals and patients, today announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of Healon D® viscoelastic, a clear dispersive ophthalmic viscosurgical device (OVD) for use as a surgical aid in cataract extraction, intraocular lens (IOL) implantation, corneal transplant, and glaucoma filtration surgery.

Healon D® OVD’s formula provides exceptional clarity in the surgical field and a high degree of protection of corneal endothelial cells. Due to its low molecular weight, Healon D® OVD coats the cornea and remains in place throughout the entire surgical process. Its lower viscosity provides ideal lubrication of IOL insertion systems. Like all members of the Healon® family, Healon D® OVD is latex free, which means a safer environment for patients and physicians.

“Whether I will be using it exclusively, or in combination with other Healon® OVDs, Healon D® viscoelastic will help me deliver optimal clinical outcomes for my patients,” said Dr. Roger Steinert, director, cornea, refractive and cataract surgery, and vice chair, clinical ophthalmology at the University of California, Irvine. “The Healon® family of OVDs provides me with the complete range of viscosurgical tools I need during every step of cataract surgery.”

The FDA’s approval of Healon D® OVD allows AMO to introduce for the first time, two new dual-pack ophthalmic viscosurgical systems (OVS) featuring Healon D® and Healon GV® OVDs as well as Healon D® and standard Healon® OVDs in convenient combination packs.

Healon GV® viscoelastic is a cohesive OVD that provides exceptional control for the surgeon during ophthalmic surgery. It has the highest molecular weight of any OVD on the market and its high viscosity allows for increased anterior chamber expansion and maintenance.

AMO plans to ship Healon D® OVD and the new dual-packs in the fourth quarter.

About the Healon® Family of OVDs

Healon® products are the standard in reliability in OVDs and have been used in over 40 million eyes during the last 28 years. The Healon® family of OVDs provides endothelial cell protection, space maintenance, and chamber stability during surgery. Surgeons have a choice of Healon®, Healon GV®, Healon5® and Healon D® OVDs to provide the protection and control they need to complement their surgical techniques and preferences.

About Advanced Medical Optics (AMO)

AMO is focused on providing the full range of advanced refractive technologies and support to help eye care professionals deliver optimal vision and lifestyle experiences to patients of all ages. Products in the cataract line include monofocal intraocular lenses (IOLs), phacoemulsification systems, viscoelastics, and related products used in ocular surgery. AMO owns or has the rights to such product brands as Tecnis®, Clariflex® and Sensar® IOLs; Sovereign®, Sovereign® Compact and WhiteStar Signature™ phacoemulsification systems with WhiteStar® technology; Healon® viscoelastics and the Baerveldt® glaucoma shunt. Products in the refractive line include wavefront diagnostic devices, femtosecond lasers and associated patient interface devices; excimer laser vision correction systems and treatment cards, and refractive implants. AMO brands in the refractive business include iDesign™, iFS™, Star S4 IR®, WaveScan Wavefront®, Advanced CustomVue™, IntraLase®, IntraLasik® and ReZoom®, Tecnis® Multifocal and Verisyse® IOLs. Products in the eye care line include disinfecting solutions, enzymatic cleaners, lens rewetting drops and artificial tears. Among the eye care product brands the company possesses are COMPLETE®, COMPLETE® Blink-N-Clean®, Consept®F, Consept® 1 Step, Oxysept® 1 Step, UltraCare®, Ultrazyme®, Total Care™ and blink® branded products. AMO is based in Santa Ana, California, and employs approximately 4,000 worldwide. The company has operations in 30 countries and markets products in approximately 60 countries.

For more information, visit the company’s Website at amo-inc.

Forward-Looking Statements
This press release contains forward-looking statements about AMO, including statements by Dr. Steinert and statements relating to expected product performance and anticipated outcomes, as well as expected shipment dates. All forward-looking statements in this press release represent AMO’s judgment only as of the date of this press release. Actual results may differ from current expectations based on a number of factors. Therefore, the reader is cautioned not to rely on these forward-looking statements. AMO disclaims any intent or obligation to update these forward-looking statements. Additional information concerning these and other risk factors may be found in previous press releases issued by AMO and AMO’s public periodic filings with the Securities and Exchange Commission, including the discussion under the heading “Risk Factors” in AMO’s 2007 Form 10-K filed in March 2008. Copies of press releases and additional information about AMO are available at amo-inc.

For the millions of Americans whose vision is slowly ebbing due to degenerative diseases of the eye, the lowly neural progenitor cell may be riding to the rescue.

In a study in rats, neural progenitor cells derived from human fetal stem cells have been shown to protect the vision of animals with degenerative eye disease similar to the kinds of diseases that afflict humans. The new study appeared recently (March 28) in the journal Public Library of Science (PLoS) One.

The lead author of the study, University of Wisconsin-Madison researcher David Gamm, says the cells – formative brain cells that arise in early development – show “some of the best rescue, functionally and anatomically” of any such work to date. In animals whose vision would typically be lost to degenerative retinal disease, the cells were shown to protect vision and the cells in the eye that underpin sight.

The new findings are important because they suggest there may be novel ways to preserve vision in the context of degenerative diseases for which there are now no effective treatments. Macular degeneration, an age-related affliction that gradually destroys central vision, is a scourge of old age, robbing people of the ability to read, recognize faces and live independently.

The finding that the brain cells protected the cells in the eye was a surprise, according to Raymond D. Lund, an author of the new study and an eye disease expert at the University of Utah and the Oregon Health and Sciences University. The neural progenitor cells, which arise from stem cells and further differentiate into different types of cells found in the central nervous system, were being tested for their ability to deliver another agent, a growth factor that has been shown to be effective in treating some types of degenerative disease.

What was surprising, say Gamm and Lund, was that the cells alone demonstrated a remarkable ability to rescue vision.

“On their own, they were able to support retinal cells and keep them alive,” says Lund, who has conducted pioneering studies of cell therapy for eye disease. “We didn’t expect that at all. We’ve used a number of different cell types from different sources and these have given us the best results we’ve ever got.”

How the cells act to preserve the deteriorating eye cells remains unknown, says Gamm. Like all cells, neural progenitor cells do many things and secrete many different types of chemicals that may influence the cells around them.

“The idea was to test the cells as a continuous delivery system” to shuttle an agent known as glial cell line-derived neurotrophic factor or GDNF, Lund explains. “It’s not a sensible thing to inject the eyes many times over years. The idea was to use the cells as a continuous delivery system, but we found they work quite well on their own.”

Lund has experimented with other cell types as therapies for preserving vision. The neural progenitor cells, a cell model developed by Wisconsin stem cell researcher Clive Svendsen, have been used experimentally to deliver the same growth factor in models of Parkinson’s disease and Lou Gehrig’s disease. Svendsen is also an author of the new PloS One report.

“It seems that the cells in and of themselves are quite neuroprotective,” says Gamm. “They don’t become retinal cells. They maintain their own identity, but they migrate within the outer and inner retina” where they seem to confer some protection to the light-sensing cells that typically die in the course of degenerative eye disease.

For researchers, the work is intriguing because the progenitor cells come from the brain itself, and not from the part of the nervous system devoted to vision.

“This cell type isn’t derived from the retina. It is derived from the brain,” says Gamm. “But we’re not asking it to become a retina. They survive in the environment of the eye and don’t disrupt the local architecture. They seem to live in a symbiotic relation ship” with retinal cells.

Gamm and Lund emphasize that the new work is preliminary, and that much remains to be done before the cells can be tested in humans: “The first thing is to show that something works, which we have done,” says Lund. “Now we need to find out why, but this is a good jumping off point. ”

The new work was funded by the Walsh Foundation, the Heckrodt Foundation and the National Institutes of Health and was conducted in conjunction with the Waisman Center Stem Cell Research Program at UW-Madison.

Contact: David Gamm
University of Wisconsin-Madison

InSite Vision Incorporated (OTCBB:INSV) announced that Bausch & Lomb has received approval of Besivance™ (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis (“pink eye”) in patients one year and older from the U.S. Food and Drug Administration (FDA). Besivance™ is formulated with InSite Vision’s DuraSite® technology, a synthetic polymer delivery vehicle that enhances the retention time of the drug on the surface of the eye.

Bausch & Lomb licensed the besifloxacin DuraSite formulation from InSite Vision in 2003 following Phase 1 clinical studies and continued development of this broad-spectrum, anti-infective drop specifically for ophthalmic use. Based on the terms of the agreement, InSite will receive competitive single-digit royalties on global net sales of the product. Besivance is being launched in the U.S. in the second quarter of 2009. The product will be promoted by the sales forces of both Bausch & Lomb and Pfizer, Inc. under a co-promotion agreement involving both companies’ prescription ophthalmic pharmaceuticals.

“We expect this product to offer patients a valuable therapeutic option for one of the most common ocular conditions worldwide,” said Louis Drapeau, InSite’s Chief Executive Officer. “The launch of Besivance represents the second commercially available product incorporating InSite’s DuraSite platform, in addition to AzaSite. This is an exciting milestone which further demonstrates the clinical value of the technology. We continue to look for new opportunities to utilize DuraSite to develop valuable products that treat unmet eye care needs.”

DuraSite is a synthetic polymer of cross-linked polyacrylic acid that stabilizes small molecules in an aqueous matrix, allowing for targeted and sustained administration. By increasing the time that a therapeutic level of medication remains on the eye’s surface, DuraSite enables a less frequent dosing schedule, increases patient compliance, and increases the therapeutic efficacy.

Source
InSite Vision

View drug information on AzaSite; Besivance.

Researchers from the University of Granada have provided an early diagnosis of certain ocular diseases that are very common today, such as age-related macular degeneration and keratitis, by applying an existing optical technique that had never before been used for this purpose.

Scientists from the UGR have studied the image quality in subjects affected by one of these two pathologies, finding a greater amount of ocular aberrations and a higher level of scattering (term associated with the dispersion that light suffers when passing through the various ocular media) in affected eyes compared with results in healthy eyes. This significantly affects visual performance.

This work has been performed by the researcher Carolina Herrera Ortiz, from the Optics Department at the University of Granada, and directed by professors Jos?� Ram??n Jim?�nez Cuesta and Francisco P?�rez Oc??n.

Age-related macular degeneration (ARMD) is the leading cause of central vision loss in developed countries, and mainly affects people of over 50 years of age. As far as keratitis is concerned, this condition causes inflammation of the cornea and can cause blindness, due to the severe alterations that the corneal surface may suffer.

Optical instruments

To carry out this work, the scientists measured the image quality with two optical instruments and used a psychophysical test for assessing visual performance. Results from patients with ARMD were compared with those obtained from a control group of similar age without any ocular pathology. Thus, the researchers could verify that for individuals affected by this condition there is an increased level of ocular scattering that could be mainly due to the disruption suffered by the light reflected in the damaged retina of the ARMD eyes, because a priori optics are not expected to be altered, since it is a retinal pathology.

On the other hand, optical quality and visual performance have also been studied in patients affected by keratitis. Eyes affected by keratitis present a poorer optical quality and a reduced visual performance that improves significantly after the resolution of the pathology. Nevertheless, once medical treatment ends, eyes that suffered from keratitis still have a worse image quality compared to the contralateral healthy eye, a result that significantly influences visual performance even having reached the normal values of visual acuity.

Visual quality characterization

The results of this research carried out at the UGR will make a full and objective characterization of visual quality in patients affected by any of these ocular pathologies. So far, the use of new techniques for assessing objectively the optic quality of the eye has been limited to studies on refractive or cataract surgery. However, as Carolina Ortiz Herrera suggests, this work “may be of particular interest to establish an early diagnosis of certain ocular diseases such as age-related macular degeneration, the main cause of central vision loss in developed countries.”

Furthermore, this technique allows researchers to carry out a monitoring of possible stages of both diseases. Ortiz Herrera stresses the importance of including “both in the clinical practice of optometry and ophthalmology” the use of new techniques that, objectively, could indicate deterioration in vision even when the visual acuity values are normal, since “vision is not only seeing well, but providing quality and comfort.”

The results of this PhD research led to two publications in journals of international prestige such as Journal of Modern Optics, Cornea. and a future issue of Current Eye Research.

Reference: Carolina Herrera Ortiz, Optics Department, University of Granada.

Source: Carolina Herrera Ortiz

University of Granada