Possible Expansion Of The Donor Pool May Address Dallas Area Cornea Shortages

Surgeons and patients from UT Southwestern Medical Center and UT Southwestern Transplant Services Center joined in a landmark study showing that corneas from older donors are as successful for transplants after five years as is tissue from younger donors, allowing possible expansion of the donor pool.

Based on findings from the study, the age pool of corneas for transplant should be expanded to include donors up to 75 years of age. The study was funded by the National Eye Institute (NEI), one of the National Institutes of Health (NIH), and published in the April issue of Ophthalmology.

“The majority of donors have been older, but there has been a great prejudice against using older tissue for fear it was going to wear out faster. So many doctors pass on tissue from older donors,” said Dr. Dwight Cavanagh, professor and vice chairman of ophthalmology at UT Southwestern, which transplants more than 200 corneas annually. Dr. Cavanagh served as principal investigator for the Dallas study.

“The data is very convincing – in fact, it is ice cold – that there isn’t a difference between old and young tissue. What matters is how many cells are alive in the tissue regardless of the age of the donor. And there are plenty of people of older age who have high cell counts,” said Dr. Cavanagh, medical director for the Transplant Services Center, which serves as the eye bank for Dallas-Fort Worth and surrounding areas.

UT Southwestern was one of 80 sites that participated in the Cornea Donor Study, which tracked patients over five years. Included were more than 20 patients from UT Southwestern’s corneal transplant program.

“The results are exactly what you’d hope for – that there is absolutely no difference between a 25-year-old and a 65-year-old in terms of how long it’s going to last. That means we can use a whole bunch of tissue now that there was prejudice against using,” said Dr. Cavanagh, who was among the researchers who conceived and encouraged implementation of the study.

Expanded testing for cornea donors is expected to limit the number available for transplants, along with the increasing popularity of laser surgeries, which often rule out the cornea for transplants. Donated corneas not used for transplants are still used in research.

The findings are particularly important around Dallas-Forth Worth, which needs more donors, said Ellen Heck, a study co-author and executive director of the Transplant Services Center. The center has to import more than 200 corneas annually from outside the area’s donor pool to meet local need.

“The reason this is important to look at is because we’re an aging population,” Ms. Heck said. “People are older now at the time of death than they used to be, so to meet an increasing need for corneas, we needed to know whether we can use corneas from older donors.”

The Transplant Services Center currently accepts corneal tissue from donors up to age 70 and is reviewing the results of the study to determine whether it should expand the age range to 75, she said.

“We don’t want to exclude potentially usable tissue when there is a waiting list,” said Ms. Heck, who sits on the executive committee for the Cornea Donor Study. “We’re always looking for donors and we always have people listed for corneal transplants. We do transplants every week in this community.”

Locally, the Transplant Services Center had 642 corneal donors in 2007. Of those, 379, or about 60 percent, were age 50 or older. The center provides corneas for the North Texas region’s roughly 15 corneal transplant surgeons on a first-come, first-served basis. Nationally, about 33,000 corneal transplants are performed annually, to replace diseased corneas or those damaged by trauma.

Cornea transplants have a high success rate (80 percent to 90 percent) and don’t have the same rejection issues common to solid organs, such as livers and hearts. Nor do they require tissue matching. Donors with vision problems such as near- or far-sightedness or even glaucoma are not excluded unless their corneas are damaged.

Interested donors can contact the Transplant Services Center at utsouthwestern.edu/.

Dr. James McCulley, chairman of ophthalmology, Dr. Wayne Bowman, professor of opthalmology, Drs. Vinod Mootha and Steven Verity, both associate professors of opthalmology, and Dr. Henry Gelender, clinical associate professor, were also involved in the study.

Visit utsouthwestern/ophth to learn more about UT Southwestern’s clinical services in opthalmology.

Dr. Dwight Cavanagh

Ellen Heck

Source: Russell Rian

UT Southwestern Medical Center

Eyeballs Vs Footballs: The Final

Professional goalkeepers fail to stop free kicks because of shortcomings in their visual system, according to new research by Cathy Craig and colleagues, from Queen’s University Belfast, Northern Ireland. The projected trajectory of a ball following a curved flight path is more difficult to judge because our visual system is not sensitive enough to gauge a change of direction at speed, mid-flight. The research1 is published in Springer-Verlag’s journal Naturwissenschaften.

Free kicks are now important goal-scoring opportunities, with specialist free kick takers often choosing to make the ball spin in order to curve the ball into the goal. Because of the size of the goalmouth, goal keepers need to anticipate the direction of the ball before they take action. Cathy Craig and team looked at whether the lateral deflection of a ball’s trajectory, caused by sidespin2, affects professional footballers’ perception of where the ball is heading.

Eleven professional footballers (attackers, mid-fielders and defenders) and nine goalkeepers from AC Milan, Olympique de Marseille, Bayer Leverkusen and Schalke 04 were asked to judge whether a range of simulated free kicks would end up in the goal or not, using a virtual reality system. The viewpoint was fixed in the centre of the goal. When there was no spin, balls arriving directly opposite the goal were consistently judged to be entering the goal. When the ball was spinning clockwise, the resulting trajectories – from the point of view of the goalkeeper – unfolded on the right-hand side of the no-spin trajectory, resulting in a goal only if the striker shot from left of the central position in front of the goal. For conditions where the ball was spinning counter-clockwise, the balls landed in the goal only when they – from the view of the striker – were kicked from the right-hand side of the no-spin trajectory. There was no difference between the judgements of the field players and goalkeepers.

Players appear to be using current ball heading direction to make their judgements about whether the free kick will end up in the goal or not, rather than accurately predicting the effects of lateral acceleration on the ball’s trajectory. Craig and colleagues conclude that these “perceptual effects find their origin in inherent limitations of the human visual system in anticipating the arrival point of an object subjected to an additional accelerative influence….The depth of experience of our participants does not seem to be able to compensate for these shortcomings in visual perception.”

Joan Robinson
joan.robinsonspringer
springer/
Springer

American Optometric Association Awards ACUVUE ADVANCE, ACUVUE OASYS Brands With Seal Of Acceptance For UV Absorbing Contact Lenses

Vistakon, a division of Johnson & Johnson Vision Care, Inc., today announced that its ACUVUE® ADVANCEâ„¢ with HYDRACLEARâ„¢, ACUVUE® ADVANCEâ„¢ for ASTIGMATISM, and ACUVUE® OASYSâ„¢ with HYDRACLEARâ„¢ PLUS Brand Contact Lenses are the first contact lenses to receive a Seal of Acceptance for Ultraviolet Absorbing Contact Lenses from the American Optometric Association’s Commission on Ophthalmic Standards. The announcement was made at the annual meeting of the American Optometric Association (AOA) in Las Vegas.

In awarding the Seal of Acceptance, AOA’s Commission on Ophthalmic Standards, which provides independent evaluation of ophthalmic related products, determined that the ACUVUE® ADVANCEâ„¢ and ACUVUE® OASYSâ„¢ brands meet AOA specifications for ultraviolet absorbing contact lenses. These specifications are in accordance with published standards of the American National Standards Institute (ANSI) and International Standards Organization (ISO).

The ANSI and ISO standards classify UV-blocking contact lenses into two groups based on the lens’s absorptive capacity at its minimum thickness. Class 2 UV-blockers must absorb at least 70 percent of UVA and more than 95 percent of UVB radiation. Class 1 UV-blockers must absorb a minimum of 90 percent UVA and at least 99 percent UVB radiation. Only products that meet these standards may claim to be UV blocking.

“Not all contact lens lines offer UV protection, and, of those that do, not all provide similar absorption levels,” explains Pat Cummings, OD, vice president, Professional Affairs, VISTAKON. “All ACUVUE® Brand Contact Lenses offer effective UV-blocking, and among contact lens brands, ACUVUE® ADVANCEâ„¢, ACVUE® ADVANCEâ„¢ for ASTIGMATISM, and ACUVUE® OASYSâ„¢ with more than 90 percent of UVA rays and 99 percent of UVB rays blocked*† are the only lenses to achieve Class I UV blocking status.”

Experts say it is difficult to isolate the exact amount of damage that UV imposes on the eye over a long period of time. However, a number of studies have shown that the effects of UV radiation are cumulative and may increase the chance of developing eye problems later in life, including cataracts and age-related macular degeneration, two leading causes of reduced vision in the United States.

Because they cover the entire cornea and limbus, UV-blocking contact lenses offer an added level of protection when worn with UV blocking sunglasses. While many sunglasses will block UV rays that enter through the lenses, most do not prevent unfiltered rays from reaching the eyes through the sides, as well as the top, and/or bottom, of the glasses. Due to their inability to block these peripheral rays, some sunglasses block as little as 50 percent of all UV radiation from reaching the eyes.

“It is just as important to block these peripheral UV rays,” warns Dr. Cummings. “UV-blocking contact lenses provide added protection by effectively blocking sunlight that may enter the cornea from the top, bottom or sides of the glasses.”

Although UV-blocking contact lenses provide important added protection for patients, they should not be viewed as a stand-alone solution. Contact lenses should always be worn in conjunction with high-quality UV-blocking sunglasses and a wide-brimmed hat for maximum UV protection for the eyes.

ACUVUE® ADVANCE™ Brand Contact Lenses with HYDRACLEAR™, ACUVUE® ADVANCE™ for ASTIGMATISM and ACUVUE® OASYS™ Brand Contact Lenses with HYDRACLEAR™ PLUS are indicated for daily wear vision correction. ACUVUE® OASYS™ may also be worn for up to six consecutive nights/seven days of extended wear as recommended by an eye care professional.

Contact lenses should not be worn for longer periods than recommended by an eye care professional. As with all contact lenses, eye problems, including corneal ulcers, can develop. Some wearers may also experience mild irritation, itching or discomfort. Lenses should not be worn if the wearer has an eye infection or experiences eye discomfort, excessive tearing, vision changes, redness or other eye problems. If these conditions occur, the wearer should contact their eye care professional. Consult the patient information guide available from your doctor for complete information. For further information, talk to your eye care professional or call 1-800-843-2020 or visit acuvue.

Johnson & Johnson Vision Care, Inc.

The VISTAKON division of Johnson & Johnson Vision Care, Inc., specializes in disposable contact lenses which it markets under such brand names as ACUVUE®, ACUVUE® ADVANCE™ with HYDRACLEAR™, ACUVUE® ADVANCE™ for ASTIGMATISM, ACUVUE® OASYS™ with HYDRACLEAR™ PLUS, ACUVUE® and ACUVUE® 2; 1-DAY ACUVUE®; ACUVUE® BIFOCAL; ACUVUE® TORIC and ACUVUE® 2 COLOURS™.

ACUVUE®, ACUVUE® ADVANCE™, HYDRACLEAR™, ACUVUE® OASYS™, ACUVUE® 2 COLOURS™ and VISTAKON® are trademarks of Johnson & Johnson Vision Care, Inc.

† Helps protect against transmission of harmful UV radiation to the cornea and into the eye.

* WARNING: UV-absorbing contact lenses are NOT substitutes for protective UV-absorbing eyewear such as UV-absorbing goggles or sunglasses because they do not completely cover the eye and surrounding area. You should continue to use UV-absorbing eyewear as directed. NOTE: Long term exposure to UV radiation is one of the risk factors associated with cataracts. Exposure is based on a number of factors such as environmental conditions (altitude, geography, cloud cover) and personal factors (extent and nature of outdoor activities). UV-Blocking contact lenses help provide protection against harmful UV radiation. However, clinical studies have not been done to demonstrate that wearing UV-Blocking contact lenses reduces the risk of developing cataracts or other eye disorders. Consult your eye care practitioner for more information.

FDA Approves UR Technology To Enhance Eyesight

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

The Omega-3 Fatty Acids DHA And EPA May Prevent Eye Disease

Nutritional supplementation
of omega-3-polyunsaturated fatty acids, particularly DHA (docosahexaenoic
acid) and EPA (eicosapentaenoic acid), may prevent eye disease, report
researchers from Harvard Medical School and the National Eye Institute.

The new study, published in the biomedical research journal Nature
Medicine, has found that dietary intake of omega-3 DHA and EPA increases
the ratio of omega-3 to omega-6 fatty acids. This ratio is significant
because increased omega-6 consumption is linked with an increased risk of
retinopathy, a sight-threatening disease that affects 4 million premature
infants and diabetics in the United States.

Retinopathy of prematurity and diabetic retinopathy feature abnormal
growth of blood vessels in the eye. The team of researchers studied the
influence of omega-3’s on vessel loss and regrowth after injury in the
mouse retina. They determined increasing the omega-3 acids by dietary
intake limited pathological blood vessel growth by reducing the production
of inflammatory mediators in the eye.

This study also confirms that Western diets are often deficient in
omega-3. Statistics verify that Americans have the lowest intake of omega-3
of any developed country. DHA, the omega-3 present in every cell membrane
of the human body, is also highly concentrated in the brain, retina, and
heart. It is vital to good health.

Studies published in peer-reviewed journals have determined that
patients with a variety of diseases are often deficient in omega-3 fatty
acids, folic acid, and other B vitamins such as vitamin B6 and vitamin B12.
Doctors are now using the prescription supplement Animi-3(R) to precisely
deliver these nutrients to different patients.

“This new research explores important considerations for
ophthalmologists with respect to omega-3 supplementation,” said PBM
Pharmaceuticals President Jack Schramm. “We specially formulated Animi-3
with nutritional deficiencies in mind, which is why it is indicated for
improving nutritional status in conditions requiring these essential
nutrients.”

Each capsule of Animi-3 contains 500 mg of omega-3 acids, including 350
mg of DHA, and 35 mg of EPA. For more information, visit
animi-3.

PBM Pharmaceuticals, Inc.
animi-3

New Drug That Could Dramatically Speed Up The Elimination Of River Blindness Across Africa Begins Clinical Trial

A clinical trial is being launched in three African countries of a drug that could eliminate onchocerciasis, or river blindness, one of the leading infectious causes of blindness across Africa. The drug, moxidectin, is being investigated for its potential to kill or sterilize the adult worms of Onchocerca volvulus, which cause onchocerciasis.

“This is a devastating illness that has plagued 30 African countries for centuries, in particular the populations in the most remote areas ‘beyond the end of the road’,” says Dr Uche Amazigo, Director of the African Programme for Onchocerciasis Control (APOC). “Over 100 million people are at risk of infection with onchocerciasis in Africa and a few small areas in the Americas and Yemen.”

Onchocerciasis is also called river blindness because the blackfly which transmits the disease breeds in fast flowing rivers, and blindness is the most incapacitating symptom of the disease which also causes debilitating skin disease.

The development of moxidectin for onchocerciasis is being conducted through a collaboration of the Special Programme for Research and Training in Tropical Diseases, which is executed by the World Health Organization (WHO/TDR), and Wyeth Pharmaceuticals. The work ranges from the development of a formulation for human use and initial studies in healthy volunteers, to clinical studies and community studies in Africa. WHO/TDR, working in partnership with African investigators and institutions, is building the capacity and managing the conduct of the clinical trials conducted in Africa. If the development is successful and results in a positive scientific opinion from the European Medicines Evaluation Agency, Wyeth, with the assistance of WHO, will request approval by national regulatory authorities in the countries where onchocerciasis is endemic.

Dr Henrietta Ukwu, Vice President, Wyeth Pharmaceuticals, says, “Wyeth is committed to improving access to innovative drugs and biologics around the globe including in the developing world. The moxidectin data have been promising so far, and as the programme moves into larger phase III studies, we are hopeful that moxidectin will constitute a significant advance against this devastating disease.”

In conducting this trial, TDR will be working with African investigators and institutions. Fifteen hundred people at 4 sites in Ghana, Liberia and the Democratic Republic of Congo will be enrolled in the study.

Preparation has been ongoing since 2007, and included building a clinical research centre in Lofa County, Liberia, and in Nord-Kivu in the Democratic Republic of Congo (DRC). Buildings not used since the war in Ituri, DRC, have been renovated. All centers have been provided with necessary equipment and the research teams trained on how to conduct the trial according to international standards.

Dr Robert Ridley, TDR’s director, says, “We work with national authorities and country partners to build research capacity and infrastructure. The training we provide to researchers and health care professionals and the experience they gather during the TDR sponsored studies enables them to conduct other clinical research later on, strengthening the health research systems in those countries.”

The trial will take place over the next two and a half years. Currently, the disease is controlled by ivermectin, which has been donated for more than 20 years by the pharmaceutical company Merck & Co., Inc., for use in onchocerciasis endemic countries. Treatment with ivermectin has enabled significant progress in the control of onchocerciasis, and currently reaches more than 60 million people in Africa annually. However, ivermectin kills the O. volvulus larvae but not the adult worms, so annual treatments for an extended period of time (at least 11-14 years) are required to ensure disease control. If moxidectin kills not only the larvae but also sterilizes or kills the adult worms, it has the potential to interrupt the disease transmission cycle within around 6 annual rounds of treatment. The drug could be distributed through the community-directed mechanisms set up in collaboration among APOC, African control programmes, and NGOs for the distribution of ivermectin.

About TDR

The Special Programme for Research and Training in Tropical Diseases (TDR) is a global programme of scientific collaboration established in 1975, sponsored by the United Nations Children’s Fund, United Nations Development Programme, World Bank and World Health Organization, and administered by WHO in Geneva, Switzerland. Its focus is on working with institutions in low and middle income countries on research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases. For more information, visit: who.int/tdr

About APOC

The African Programme for Onchocerciasis Control (APOC) is a collaboration between governments, multilateral and bilateral agencies, foundations, non-governmental development organizations (NGDOs), affected communities, the scientific community and the private sector. The objective of the APOC Phase II and Phasing out Period (2008-2015) “is to establish, within a period of 12 to 15 years, effective, self-sustainable, community-directed treatment with ivermectin throughout the endemic areas within the geographic scope of the Programme, develop the evidence base and assist countries to determine when and where ivermectin treatment can be stopped, and, if possible, in selected and isolated foci, to eradicate the vector, by using environmentally safe methods. The World Bank is the fiscal agent and the World Health Organization (WHO) is the executing agency of APOC, providing administrative, technical and operational research support. For more information, visit: who.int/apoc

Source
WHO

OTHERA Announces Positive Interim Phase 2 Results Of OT-551 Eye Drop Treatment For Dry AMD

Othera Pharmaceuticals, Inc., a specialty pharmaceutical company focused on treatments for ophthalmic diseases, has announced positive interim data results from its Phase 2 trial of OT-551 in treating geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD) for which there is no FDA-approved treatment. The 12-month findings from the 2-year OMEGA trial suggest an emerging trend for reducing moderate vision loss (i.e., 15 letters or more on the ETDRS chart) in patients with GA who were treated with OT-551 compared with placebo. This numeric trend was more pronounced in subgroups based on GA characteristics or level of visual acuity at baseline.

OT-551 is a topically-dosed, patented small molecule that acts on oxidative stress and disease-induced inflammation. A number of scientific publications from leading researchers in ophthalmology have linked both oxidative stress and inflammation to the progression of GA and the ensuing vision loss in patients. OT-551 has demonstrated a dose-dependent protective effect on photoreceptor activity in an animal model of AMD, and has been shown to reach the back of the eye after topical dosing in multiple species. This profile supports the rationale for studying the drug in patients with degenerative retinal conditions, such as GA. OT-551 is the first eye drop to ever be tested in a clinical trial as a treatment for dry AMD.

“It is encouraging that Othera’s interim analysis of the OMEGA study suggests a promising effect of OT-551 on visual acuity in patients with GA associated with dry AMD. We are in great need of improved treatments for this condition and I look forward to longer term follow-up from the patients enrolled in this study,” commented Paul Sternberg, Jr., MD, Professor and Chairman of the Vanderbilt Eye Institute and Chairman of the OMEGA study.

“I am particularly excited about these results in light of the absence of any approved treatment today for this slowly progressing, advanced form of dry AMD,” commented Al Reaves, PhD, Othera’s Senior Vice President of Clinical Development. “These initial clinical results confirm preclinical findings showing that OT-551 can be administered as an eye drop to affect photoreceptors in the retina. Based on these preliminary results, OT-551 continues to exhibit the excellent safety profile seen in prior studies. Given OT-551’s safety profile and the positive trend on visual acuity, continued follow-up of this elderly population with GA should allow us to profile the drug’s effect on visual acuity and better understand its long term safety.”

The analysis of drug safety and effectiveness for the entire study population and in subgroups is still in progress. An independent Data and Safety Monitoring Committee is scheduled to review the interim results later this month. In May, a summary of the top-line results will be discussed at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida.

About The OT-551 Phase 2 OMEGA Trial

The OMEGA (OT-551 Multi-center Evaluation of Geographic Atrophy) study is a randomized, double-masked, dose-ranging, multi-center, Phase 2 study of topical OT-551 in patients with GA associated with AMD. One hundred and thirty-seven (137) patients were enrolled at 20 leading retinal disease treatment centers across the U.S. in this 2-year study.

About Geographic Atrophy

There are currently no FDA-approved drug treatments for dry AMD, which affects over 14 million Americans in this aging demographic population. Of these, roughly 1 million Americans have GA, the most advanced and severe form of dry AMD, and many of these cases will progress to legal blindness. Geographic atrophy is caused by the gradual loss of the retinal cells that are primarily responsible for central vision, and which are necessary for important tasks such as driving, reading, and identifying faces. Unlike other forms of AMD, the damage to the retina from GA is irreversible.

About Othera Pharmaceuticals, Inc.

Founded in 2002, Othera Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing treatments for ophthalmic diseases.

In addition to OT-551, Othera is developing a second product, OT-730, a novel topical ocular treatment with the promise of improved safety over current therapies for lowering intraocular pressure (IOP). A recently completed Phase 1 – 2 proof-of-concept study showed a peak IOP-lowering effect comparable to that of timolol, the most widely prescribed beta blocker. There was no observed effect on pulse rate with OT-730.

For information please visit Othera’s website at othera.

Source
Othera Pharmaceuticals, Inc

Bausch & Lomb Receives FDA Approval Of Besivance(TM), New Topical Ophthalmic Antibacterial For The Treatment Of Bacterial Conjunctivitis (‘Pink Eye’)

Bausch & Lomb, a world leader in eye health, announced that the U.S. Food and Drug Administration (FDA) approved Besivance(TM) (besifloxacin ophthalmic suspension) 0.6% for the treatment of bacterial conjunctivitis, commonly referred to as “pink eye.” Besivance(TM) is a new topical ophthalmic antibacterial, administered via sterile ophthalmic drops, that treats a wide range of eye pathogens including those that most commonly cause bacterial conjunctivitis.(4) Bacterial conjunctivitis is one of the most common ocular conditions worldwide.(2)

In December 2008, an FDA Advisory Committee voted unanimously to recommend approval of Besivance.

Besivance is the first fluoroquinolone specifically developed for ophthalmic use and is the first and only ophthalmic fluoroquinolone with no previous systemic use. It offers broad-spectrum antibacterial activity, including activity against the strains that are the most common causes of bacterial conjunctivitis.(3)

“Topical ophthalmic besifloxacin offers physicians the opportunity to provide patients with an anti-infective that treats a broad range of bacterial ocular pathogens,” said Marguerite McDonald, MD, FACS, Clinical Professor of Ophthalmology at NYU School of Medicine, New York, New York.

The FDA approval of Besivance was based on a series of eight clinical trials. These studies were designed to test the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics with the topical antibacterial. Its efficacy was evaluated in three multi-center, randomized, double-masked trials involving nearly 2,400 patients with a clinical diagnosis of bacterial conjunctivitis. In clinical trials, investigators found that Besivance treatment resulted in a greater proportion of patients experiencing clinical resolution and microbial eradication, when compared to its vehicle.(4)

“Today’s FDA approval of Besivance provides patients with an advanced therapy that can eradicate bacterial conjunctivitis at its source both safely and effectively,” said Flemming Ornskov, M.D., M.P.H., corporate vice president and global president, Pharmaceuticals, Bausch & Lomb. “At Bausch & Lomb we are committed to developing innovative eye health products that help enhance patients’ overall quality of life, and we are pleased to offer the medical community a new treatment option for this exceedingly common condition.”

Besivance will be available by prescription in U.S. pharmacies in the second quarter of 2009. Besivance will be promoted by both the Bausch & Lomb and Pfizer, Inc. sales forces.

About Bacterial Conjunctivitis

Conjunctivitis is one of the most common eye diseases seen worldwide.(2) Often referred to as “pink eye,” bacterial conjunctivitis is an infection of the conjunctiva, the outer-most layer of the eye that covers the white part of the eye.(5) This contagious disease occurs in patients of all ages. Typical signs include a red eye and discharge that persists throughout the day.(6) The acute form of contagious conjunctivitis is most frequently seen in infants, schoolchildren and the elderly, generally as a result of bacterial or viral infections.(2) Acute red eyes, most frequently diagnosed as acute bacterial conjunctivitis, account for 1 to 4 percent of all physician visits in the developed world.(2)

About Besivance

Besivance (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis in patients one year and older, caused by susceptible isolates of the following bacteria: CDC coryneform group G, Corynebacterium pseudodiphtheriticum*, Corynebacterium striatum*, Haemophilus influenzae, Moraxella lacunata*, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hominis*, Staphylococcus lugdunensis*, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Streptococcus salivarius.* The asterisk denotes efficacy for these organisms was tested in fewer than 10 infections.

Besivance is for topical ophthalmic use only, and should not be injected subconjunctivally or directly into the anterior chamber of the eye.(4) As with other anti-infectives, prolonged use of Besivance may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy.(4) Although Besivance is not intended to be administered systemically, quinolones administered systemically have been associated with hypersensitivity reactions, even following a single dose. Patients should be advised to discontinue use immediately and contact their physician at the first sign of a rash or allergic reaction.(4) The most frequently reported adverse event in clinical studies was conjunctival redness, reported in approximately 2% of patients. Other adverse events reported in approximately 1-2% of patients included blurred vision, eye pain, eye irritation, eye pruritus and headache.(4) The safety and effectiveness of Besivance in infants below one year of age has not been established.(4)

About Bausch & Lomb

Bausch & Lomb is the eye health company dedicated to perfecting vision and enhancing life for people around the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. The Bausch & Lomb name is one of the best-known and most respected healthcare brands in the world. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 10,000 people worldwide. Its products are available in more than 100 countries.

About Pfizer Ophthalmics

Pfizer Ophthalmics, part of Pfizer’s Specialty Care business unit, is committed to preserving sight and eliminating preventable blindness and expanding its portfolio through licensing and partnerships. Pfizer Ophthalmics discovers, develops and provides leading treatments in ophthalmology to support patients who are at risk of blindness or suffering from vision impairment, and to serve the health care professionals who treat them.

References

1. Cavuoto K, Zutshi D, Karp CL, et al. Update on bacterial conjunctivitis in South Florida. Ophthalmology 2008;115:51-6.

2. Hovding G. Acute bacterial conjunctivitis. Acta Ophthalmol 2008;86:5-17.

3. Karpecki, P, DePaolis, M, Hunter, J, et al. Besifloxacin Opthalmic Suspension 0.6% in Patients with Bacterial Conjunctivitis: A Multicenter, Prospective, Randomized, Double-Masked, Vehicle-Controlled, 5-Day Efficacy and Safety Study. Clinical Therapeutics 2009: 31:3-11

4. Besivance(TM) Prescribing Information

5. MedicineNet, Facts About “Pink Eye”.

6. Tarabishy, A, Jeng, B. Bacterial Conjunctivitis: A Review for Internists. Cleveland Clinical Journal of Medicine. 2008: 75:7-507.

Besivance(TM) is a trademark of Bausch & Lomb, Inc.

Source: Bausch & Lomb

View drug information on Besivance.

NICE Award For West Midlands Sight-Saving Service

A new specialist eye service in Birmingham has helped save the sight of nearly 450 people in its first year, more than three times the number originally planned. Now the ophthalmology team at University Hospitals Birmingham NHS Foundation Trust, who set up the service, has been honoured with an award from the National Institute for Health and Clinical Excellence (NICE).

The team, hailed for their project, “Saving sight the NICE way” won the clinical category of the NICE Shared Learning Awards for successfully implementing NICE guidance on the use of the drug ranibizumab (Lucentis) for the treatment of a type of eye disease called wet age-related macular degeneration (wet AMD). There are about 26,000 new cases of wet AMD in the UK each year.

Work on the clinic began in 2007 after the ophthalmology team began following the development of this guidance. Working with a range of experts, the service was able to treat its first patient with ranibizumab just three working days after the guidance recommending the treatment was published. Thanks to short waiting times and a flexible way of working all patients receive their first assessment within one week of being referred and none of those treated during the first year have been registered blind.

Marie Tsaloumas and Helen Palmer are consultant ophthalmologists at University Hospitals Birmingham NHS Foundation Trust and lead the team at the eye service. Marie Tsaloumas said: “Having anticipated the NICE guidance, we worked closely with a range of GPs, optometrists, patients and others to establish an effective and efficient service. The number of patients treated is a clear testament to the effectiveness of this approach and we expect to help even more in the coming years.

“The main lessons we have learnt are that NICE guidance is your ‘friend’ in developing services to help patients, and that team work is essential.”

Two other projects from the West Midlands also walked away with prizes from the NICE Shared Learning Awards. The Staffordshire branch of the drug and treatment charity Addaction won the ‘Health and Wellbeing’ category for their work to improve a needle and syringe programme using appropriate NICE guidance. South Staffordshire and Shropshire NHS Foundation Trust came top in the ‘General’ category for their work to ensure doctors and other healthcare professionals are aware of relevant NICE guidance to help them treat, and give information to, patients. Each winner was presented with a trophy, certificate and cheque for ??1,000 to help them put NICE guidance into practice.

Chris Connell, NICE’s Implementation Consultant for the West Midlands who helps local organisations put NICE guidance into practice, said: “To have the West Midlands win all three categories at the NICE Shared Learning Awards highlights the hard work by organisations in the region to use NICE guidance for the benefit of patients.

“All three projects thoroughly deserve their awards. The team at University Hospitals Birmingham NHS Foundation Trust in particular deserve their accolade. The gift of sight is truly precious and the team’s unwavering dedication to helping save the sight of hundreds of patients is inspiring.”

Nominations for the 2010 Shared Learning Awards are now open. NICE is encouraging any organisations to submit examples to the Shared Learning Database of how they are putting NICE guidance into practice, which will automatically be entered into the awards. More information and examples can be found here.

Source
NICE

View drug information on Lucentis.

Lazy Eye Discovery: How An Old Gene Learns New Tricks

Researchers have made a discovery which could lead the way for new treatments into a rare eye disorder which if not treated can result in permanent blindness in childhood.

An eye disorder which leads to “lazy eye” (strabismus) first described in early 1900, and a gene known since 1990 to be widely expressed within the nervous system, have now been linked together.

Mutations of the CHN1 gene give rise to a hyperactive gene product called a2 chimerin that in turn affects the normal eye development.

These new findings published in Science today (Thursday 24 July) demonstrate how genetic errors can explain developmental errors.

The research shows that seven CHN1 mutations found in families with a history of Duane’s Retraction Syndrome (DRS) – a rare, disorder of eye movement which is present at birth – lead to abnormal development of the cranial nerve III which is integral to normal eye development.

A large team of experts from UK and USA, including a scientist now based in Aberdeen, have been involved in the research into the CHN1 gene and its connections to this unique syndrome which affects 1% of the general population of individuals with eye movement disorders worldwide. The condition may affect one or both eyes and is more common in girls.

Dr Maria Psatha, University of Aberdeen who co-authored the paper said: “In normal eye movements, 3 cranial nerves control 6 eye muscles, which control the movement of each eye horizontally, up and down, or at an angle. In DRS,miswiring between the muscles and the nerves can cause some eye muscles to contract when they should not and other eye muscles not to contract when they should. This typically occurs around the sixth week of pregnancy when the cranial nerves and eye muscles develop. During this time, the mutations of the gene of CHN1 have now been shown to explain the pathophysiology of the DRS disorder.”

It is hoped that this latest discovery will lead to future developments in the treatment of Duane’s Syndrome.

Dr Psatha,continues: “I have been very fortunate to be part of a very fruitful international interdisciplinary collaboration that resulted in a high impact paper reporting the findings of the gene responsible for an important yet rare eye disorder that affects children. I look forward to more collaboration of this calibre in the very vibrant environment of the University of Aberdeen.”

The research was undertaken by Dr Maria Psatha while at King’s College of London in collaboration with the Harvard Medical School

University of Aberdeen
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