Month: July 2013

Scientists at Schepens Eye Research Institute have shown for the first time that a laser burn to one retina can cause both eyes to lose a special protective ability known as immune privilege. Immune privilege protects the eye without the inflammation of the body’s normal immune response, which can further damage delicate eye tissue. This finding, published in the February 2009 American Journal of Pathology, has implications for treating patients with laser burns sustained on the battlefield and in other modern settings.

The discovery is also significant because it suggests a previously unknown communication between the two eyes. “This deepens our understanding of the way immune privilege works,” says Dr. Joan Stein Streilein, principal investigator of the study and senior scientist at Schepens Eye Research Institute.

Immune privilege is a modification of the body’s normal immune response. It protects the eye, the brain and the reproductive system without the full-blown immune response that uses inflammation to violently reject foreign tissue or invaders.

While inflammation in other parts of the body is a useful battle between immune and foreign cells, it is too aggressive for fragile eye, brain and reproductive tissues, and, in the case of the eye, can even lead to blindness. Immune privilege, which intervenes in the battle, is also what prevents the eye from rejecting corneal transplants, making them the most common and successful of transplanted tissues.

In her laboratory, Stein-Streilein and her team made tiny laser burns in one of the retinas of 15 mice. They then injected either the burned or the unburned eyes of each mouse with the antigen, Ovalbumin. Antigens are substances that the body perceives as foreign and against which it mounts a defense.

They found that immune privilege was disrupted in both eyes after six hours and continued to be disrupted even after 56 days.

When they injected the same antigen into the eyes of a group of control mice without burns, they observed no inflammation.

Since created in the 1960s, lasers have found their way onto the battlefield, into the operating rooms and into modern research laboratories. While ophthalmologists have been aware of the local damage done by laser burns to retinas, they have not been tuned into the possibility of long-term loss of immune privilege in one or both eyes.

Understanding mechanisms that destroy or disrupt immune privilege will ultimately lead to novel therapies to restore that special privilege not only in the eye but in the brain and the reproductive system as well, she adds.

The next steps for the team will be to study the novel mechanisms that allow for communication between the injured and non-injured eye.

Other scientists involved in the study include: First author, Hong Qiao, MD, PhD, and second author Kenyatta Lucas, PhD, both scientists at Schepens.

Schepens Eye Research Institute is an affiliate of Harvard Medical School and the largest independent eye research institute in the nation.

Schepens Eye Research Institute
schepens

Foresight Biotherapeutics, Inc. announced data from a pre-clinical study designed to assess the safety and efficacy of the topical administration of FST-100 in a highly regarded Ad5 NZW rabbit model of adenoviral conjunctivitis. FST-100 demonstrated a clinically and statistically significant reduction in signs of adenoviral conjunctivitis versus all other groups including the current experimental “gold standard”, topical cidofovir. The study was conducted at the Louisiana State University (LSU) Health Science Center, LSU Eye Center in New Orleans, Louisiana by Professor James M. Hill and colleagues, in the Departments of Pharmacology, Microbiology, Ophthalmology and Neuroscience.

The randomized controlled study was conducted in 40 eyes of 20 rabbits experimentally inoculated with human adenovirus type 5. The study was designed to investigate the safety and efficacy of topically administered FST-100 compared to both active controls and to placebo. Animals were randomized 1:1:1:1 (5 rabbits per group) to FST-100, topical 0.5% cidofovir, Tobradex® (tobramycin/dexamethasone) ophthalmic suspension and placebo. Treatment began one day after viral inoculation and continued for 8 days. Eyes were scored daily for clinical parameters including conjunctival inflammation, fragility of ocular blood vessels, purulent discharge, eyelid inflammation, and excessive tearing. Daily viral titer data using a plaque reduction assay are currently undergoing analysis.

The study concluded that FST-100 was superior to all other arms of the study. Dramatic clinical improvement was seen in some treated rabbits as early as 48 hours after the first dose of FST-100. Complete clinical resolution was observed in all FST-100 treated eyes. No other group reached complete clinical resolution. Specifically, treatment with cidofovir, Tobradex® or placebo resulted in injected and inflamed corneas, eyelid and conjunctival inflammation and injection with sub-conjunctival heme.

Professor Hill commented, “This set of data using FST-100 in this very challenging animal model of adenoviral conjunctivitis is highly encouraging. Specifically, no other drug that I have tested has provided such dramatic clinical efficacy, indicating that further studies in human adenoviral conjunctivitis are certainly warranted.”

Source
Foresight Biotherapeutics, Inc.

ISTA Pharmaceuticals, Inc. (Nasdaq: ISTA) announced the U.S. Food and Drug Administration (FDA) has approved Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% as a twice-daily prescription eye drop treatment for ocular itching associated with allergic conjunctivitis in patients two years of age and older.

“Bepreve offers a new, safe and effective way to treat the itching caused by ocular allergies. We expect to have Bepreve available to ophthalmologists and patients in the United States in the fourth quarter of 2009,” stated Vicente Anido, Jr., Ph.D., President and Chief Executive Officer of ISTA. “Because of the timing of this approval and the strength of our underlying business, we will accelerate all of the launch activities immediately, including the scale-up of the sales force. This will allow us not only to finish this year very strongly but also enter next year with an expanded sales force in place. Bepreve and Xibrom will share the top spot on our promotional activities, but we will continue to devote time and energy to Istalol, too.”

ISTA conducted multiple clinical studies, evaluating the safety, efficacy, onset and duration of effect of Bepreve. Two Phase 3 double-masked, placebo-controlled, conjunctival allergen challenge (CAC) studies demonstrated Bepreve significantly reduced ocular itching. In addition, the studies achieved statistical significance and demonstrated Bepreve’s rapid onset of action in providing relief to persons with ocular itching associated with allergic conjunctivitis.

“Patients who experience ocular itching due to allergies want comfortable, quick and long-lasting relief for their eyes. Bepreve is the first truly new treatment for allergic conjunctivitis approved in several years. Allergic conjunctivitis, not to be confused with viral or bacterial conjunctivitis or pink eye, is an eye allergy that often results in ocular itching, and I am excited patients will have this new treatment option,” commented Gregg J. Berdy, M.D., Assistant Professor of Clinical Ophthalmology, Washington University School of Medicine.

Dr. Anido concluded, “As we are accelerating our launch timing to the fourth quarter and are expanding our sales force, we now expect to be able to recognize Bepreve revenue this year. In addition, Xibrom and Istalol are performing particularly well year to date, giving us confidence to increase our full-year 2009 net product revenue guidance for our four marketed products to $101 million to $104 million. Our total net revenue for full-year 2009, including net product revenue and $2.9 million from the one-time recognition of deferred revenue resulting from our previously disclosed modification of our partnership with Otsuka, is now expected to be $104 million to $107 million. We also are reiterating our guidance that ISTA will be operating income neutral in 2009, as our increased net revenue will offset the costs associated with launching Bepreve and expanding our sales force.”

About the U.S. Ocular Allergy Market

Approximately 60 to 90 million Americans suffer from ocular allergy. Allergic conjunctivitis, the most common allergy affecting the eyes, is caused by exposure to certain allergens such as pollen from trees, grass and plants, animal dander, feathers, dust mites and molds. Ocular itching is the most common symptom of ocular allergy, reported by more than 75% of allergy patients. Current treatments for allergic conjunctivitis include antihistamines, mast cell stabilizers and anti-inflammatories. Based on data from IMS Health, in 2008 approximately 6.6 million prescriptions were filled for ocular allergy treatments, resulting in sales of approximately $560 million.

About Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%

Bepreve is a non-sedating, highly selective antagonist of the histamine (H1) receptor. It has a stabilizing effect on mast cells, and it suppresses the migration of eosinophils into inflamed tissues. The compound’s primary mechanisms of action are believed to make it an effective treatment against ocular itching associated with allergic conjunctivitis.

Bepotastine was approved in Japan for use as a systemic drug in the treatment of allergic rhinitis and urticaria/pruritus in July 2000 and January 2002, respectively, and is marketed by Mitsubishi Tanabe Pharma Corporation (formerly Tanabe Seiyaku Co., Ltd.) under the brand name TALION(R). TALION was co-developed by Tanabe Seiyaku and Ube Industries, Ltd., who discovered bepotastine. In 2001, Tanabe Seiyaku granted Senju Pharmaceutical Co., Ltd., exclusive worldwide rights, with the exception of certain Asian countries, to develop, manufacture and market bepotastine for ophthalmic use. In 2006, ISTA licensed the exclusive North American rights from Senju to an eye drop formulation of bepotastine for the treatment of allergic conjunctivitis. In 2007, ISTA licensed exclusive North American rights to nasal dosage forms of bepotastine from Tanabe Seiyaku and obtained a future right to negotiate for a North American license to oral dosage forms of bepotastine for allergy treatment.

INDICATIONS AND USAGE

Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5% is a histamine H1 receptor antagonist indicated for the treatment of itching associated with signs and symptoms of allergic conjunctivitis.

DOSAGE AND ADMINISTRATION

Instill one drop of Bepreve(TM) into the affected eye(s) twice a day (BID).

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONSbr>
To minimize the risk of contamination, do not touch dropper tip to any surface. Keep bottle tightly closed when not in use.

Bepreve(TM) should not be used to treat contact lens-related irritation.

Remove contact lenses prior to instillation of Bepreve(TM).

ADVERSE REACTIONS

The most common reported adverse reaction occurring in approximately 25% of subjects was a mild taste following instillation. Other adverse reactions occurring in 2-5% of subjects were eye irritation, headache, and nasopharyngitis.

About ISTA Pharmaceuticals

ISTA Pharmaceuticals is the fourth largest branded ophthalmic pharmaceutical business in the U.S. ISTA’s four marketed products plus its product candidates include therapies for inflammation, ocular pain, glaucoma, allergy, and dry eye. The Company is developing a strong product pipeline to fuel future growth and market share, thereby continuing its growth to become the leading niche ophthalmic pharmaceutical company in the U.S.

Bepreve(TM) (bepotastine besilate ophthalmic solution) 1.5%, Xibrom(TM) (bromfenac ophthalmic solution) 0.09%, and Istalol(R) (timolol maleate ophthalmic solution) 0.5% are trademarks of ISTA Pharmaceuticals.

Any statements contained in this press release that refer to future events or other non-historical matters are forward-looking statements. Without limiting the foregoing, but by way of example, statements contained in this press release related to ISTA’s financial guidance for 2009, the expansion of ISTA’s sales force, and ISTA’s anticipated devotion of resources toward the marketing of Bepreve, Xibrom and Istalol are forward-looking statements. Except as required by law, ISTA disclaims any intent or obligation to update any forward-looking statements. These forward-looking statements are based on ISTA’s expectations as of the date of this press release and are subject to risks and uncertainties that could cause actual results to differ materially. Important factors that could cause actual results to differ from current expectations include, among others, uncertainties and risks regarding market acceptance of and demand for ISTA’s approved products; delays and uncertainties related to the FDA or other regulatory agency approval or actions; and such other risks and uncertainties as detailed from time to time in ISTA’s public filings with the U.S. Securities and Exchange Commission, including but not limited to ISTA’s Annual Report on Form 10-K for the year ended December 31, 2008, and its most recent Quarterly Report on Form 10-Q for the quarter ended June 30, 2009.

Source: ISTA Pharmaceuticals, Inc

View drug information on Bepreve; Bromfenac.

Alcon, Inc. (NYSE:ACL) announced today that the European Medicines Agency (EMEA) has approved Alcon’s fixed combination eye drop, AZARGA® (brinzolamide 10mg/ml+timolol 5mg/ml) ophthalmic suspension, for treatment of elevated intraocular pressure (IOP) associated with open-angle glaucoma or ocular hypertension in adult patients for whom monotherapy provides insufficient IOP reduction.

Two clinical studies showed AZARGA® ophthalmic suspension to be more comfortable and better tolerated by patients than COSOPT*. In a patient preference study comparing AZARGA® and COSOPT*, 79 percent of the glaucoma patients who expressed a preference preferred AZARGA®. Many physicians believe that more comfortable medication may enhance adherence to dosing regimens for patients with glaucoma, which is critical to protecting them against potential vision loss.

Clinical trials supporting the approval also showed the active ingredients in AZARGA® suspension to be more effective when delivered in combination than either of them individually. AZARGA® demonstrated superior IOP-lowering efficacy at every time point measured in the study versus the individual components alone, while demonstrating a similar safety profile. In addition, a head to head study showed that AZARGA® provides IOP lowering efficacy that is similar to COSOPT*.

“This new product is a direct result of our commitment to offering more treatment options to patients affected by glaucoma,” said Sabri Markabi, M.D., Alcon’s senior vice president of research and development and chief medical officer. “It is important to have an effective treatment that is both comfortable and convenient for patients with a chronic disease such as glaucoma.”

AZARGA® ophthalmic suspension will be available in Europe beginning in early 2009.

About AZARGA® Ophthalmic Suspension

AZARGA® ophthalmic suspension is indicated for the decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. AZARGA® is a formulation that includes both brinzolamide and timolol. This therapy is contraindicated in patients with hypersensitivity to the active ingredients in this product. For complete product information, see product insert.

About Glaucoma

Glaucoma, a group of diseases that can damage the eye’s optic nerve, is the second leading cause of blindness worldwide. The onset of glaucoma occurs with no symptoms, but if it remains untreated, gradual loss of peripheral vision may ensue. When diagnosed early, glaucoma can be treated with medication, laser trabeculoplasty, conventional surgery or a combination of therapeutic options. Remaining vision may be preserved through treatment, but there is currently no cure for glaucoma and lost vision cannot be restored. Compliance or adherence to these treatments is essential to retain vision, but for many reasons adherence is a problem for patients with glaucoma. Some of these reasons include a lack of symptoms, drug discomfort, multiple drugs prescriptions and complicated dosing regimens.

About Alcon

Alcon, Inc. is the world’s leading eye care company, with sales of approximately $5.6 billion in 2007. Alcon, which has been dedicated to the ophthalmic industry for 60 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contact lens care solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon’s majority shareholder is Nestle, S.A., the world’s largest food company. For more information on Alcon Inc., visit the company’s Web site at alcon.

* COSOPT is a registered trademark of Merck & Co., Inc.

Caution Concerning Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by our forward-looking statements. These statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. You should read this press release with the understanding that our actual future results may be materially different from what we expect. Except to the extent required under the federal securities laws and the rules an regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

Alcon, Inc.

View drug information on Cosopt.

The paper is being published online in the Proceedings of the National Academy of Sciences.

“While a number of new drugs that inhibit new blood vessel growth are now available in the clinics, no one so far has been cured with available anti-angiogenic agents,” said Professor Martin Friedlander, a Scripps Research scientist and retina specialist at Scripps Clinic who led the study. “Our study shows that combining anti-angiogenic agents that target multiple angiogenic pathways can significantly increase the effectiveness of such a therapeutic approach. Such combination angiostatic therapy provides a whole new range of treatment options for patients with neovascular diseases, where complete inhibition of new blood vessel growth is the desired result.”

While new blood vessel growth from preexisting capillaries (“angiogenesis”) is fundamental to survival, the abnormal formation of new blood vessels (“neovascularization”) contributes to the pathogenesis of tumor growth and metastasis as well as the vast majority of diseases that lead to catastrophic loss of vision. A number of angiostatic molecules have been used to impair blood vessel formation as clinical adjuncts to conventional radio- and chemotherapy. Others have proven to be modestly effective in treating neovascular eye diseases.

The new study combined the actions of three classes of angiostatic compounds, each targeting different angiogenic pathways, and showed striking results in the treatment of an animal model of glioblastoma, a highly malignant brain cancer, and ischemic retinopathy, excessive blood vessel growth in the eye that is a major cause of blindness worldwide.

“Our combination therapy reduced tumor mass and increased survival in the glioblastoma model,” Friedlander said. “In models of neovascular eye diseases, the therapy resulted in complete inhibition of pathological neovascularization in more than 60 percent of the eyes; over 90 percent had greater than 75 percent inhibition of new vessel growth with no adverse affects on normal tissue vasculature. In contrast, individual therapies with comparable doses of individual drugs were minimally effective, if at all.”

Importantly, Friedlander notes that the use of single therapies can result in the activation of alternative compensatory pro-angiogenic pathways designed to stimulate new vessel growth, while the combination approach significantly reduced such compensatory upregulation.

“The fact that multiple angiogenic pathways are activated in response to single therapies, but not to combination treatment, supports the hypothesis that compensatory mechanisms might prevent single angiostatics from inhibiting neovascularization,” he said. “These results suggest that combination therapy prevents this natural compensation, enhancing the overall anti-angiogenesis effect.”

In combination, the angiostatic therapies were effective at much lower concentrations than when used as individual monotherapies. Even when diluted up to 100-fold, the triple combination inhibited angiogenesis at levels comparable to optimal doses of any single therapy. A ten-fold dilution of the triple combination demonstrated extensive neovascular inhibition with complete inhibition observed in 44 percent of the treated retinas. At these same concentrations, the angiostatic activity of each monotherapy was negligible, indicating that combining multiple angiostatic drugs was synergistic rather than additive.

The effectiveness of combination therapies at relatively low doses may be a distinct advantage in therapy, the study noted. In the elderly or diabetic patients, high levels of circulating angiostatics could precipitate stroke or heart attack due to the fact that such patients make collateral blood vessels in hearts and brains that are starved for oxygen from vascular diseases such as arteriosclerosis, hypertension, and diabetes. For these and other patients, the use of lower doses of angiostatic therapies could minimize potential adverse side effects.

“The point of the study was to show proof-of-concept that targeting multiple angiogenic pathways will be more effective than inhibiting single ones due to potential compensatory upregulation,” Friedlander said. “As more and more anti-angiogenic agents reach the market, there will be even more combinations to choose from. In our laboratory, we’re now looking at new combinations of approved angiostatic drugs to see if we can achieve similar promising results that can have immediate translation into the clinic.”

Other authors of the study, Combination Angiostatic Therapy Completely Inhibits Ocular and Tumor Angiogenesis, were Michael I. Dorrell, Edith Aguilar, Lea Scheppke, and Faith H. Barnett of The Scripps Research Institute. See: Proceedings of the National Academy of Sciences of the United States of America

The study was supported by the National Eye Institute, the Scripps Fonseca/Mericos Fund, the V. Kann Rasmussen and MacTel Foundations, and the Skaggs Scholars in Clinical Science.

About The Scripps Research Institute

The Scripps Research Institute is one of the world’s largest independent, non-profit biomedical research organizations, at the forefront of basic biomedical science that seeks to comprehend the most fundamental processes of life. Scripps Research is internationally recognized for its discoveries in immunology, molecular and cellular biology, chemistry, neurosciences, autoimmune, cardiovascular, and infectious diseases, and synthetic vaccine development. Established in its current configuration in 1961, it employs approximately 3,000 scientists, postdoctoral fellows, scientific and other technicians, doctoral degree graduate students, and administrative and technical support personnel. Scripps Research is headquartered in La Jolla, California. It also includes Scripps Florida, whose researchers focus on basic biomedical science, drug discovery, and technology development. Currently operating from temporary facilities in Jupiter, Scripps Florida will move to its permanent campus in 2009.

Contact: Marisela Chevez

Scripps Research Institute

With support from the National Federation of the Blind (NFB), Melissa Resnick of Merrick, New York, will become the first
blind nursing student at Nassau Community College (NCC). Admission to NCC’s Nursing Department is highly competitive and the
Department is widely respected for its academic excellence. The college confirmed her acceptance after initially expressing
concerns over her ability to perform the required classroom and clinical work. Ms. Resnick will start her classes on Friday,
January 21, 2005.

“Ms. Resnick is an exceptionally well-qualified woman who will be an asset to the nursing program at Nassau Community
College,” said Marc Maurer, President of the National Federation of the Blind. “We applaud the college for taking this
important step towards full acceptance of blind people into the medical professions. Blind doctors and nurses are bringing
new insights into patient care and Melissa will surely inspire other blind youth to follow their dreams into nursing.”

Ms. Resnick has been attending NCC since June 2003. She applied to the nursing program in October 2004. As part of the
process of allaying NCC’s concerns about her ability to successfully complete the nursing program, Ms. Resnick, a long-time
member of the NFB, the foremost consumer organization of blind people in the United States, turned to the organization for
assistance.

The NFB compiled numerous examples of how other blind individuals have used alternative (non-sighted) techniques to complete
their medical and other healthcare studies. After considering the information, NCC agreed to admit Ms. Resnick to NCC’s
nursing program.

Blind since birth, Ms. Resnick has always dreamed of becoming a nurse. “NCC, through its Center for Students with
Disabilities, which assists 1,000 disabled students each semester, has a solid record of working to expand educational
opportunities for disabled students,” said Dr. Sean A. Fanelli, President of NCC. “We look forward to working with Ms.
Resnick to help her realize her dream.” NCC is one of the largest community colleges in the country, with more than 21,000
students enrolled.

Ms. Resnick received a Bachelor’s degree in biology from the State University of New York (SUNY) at Albany. Although
SUNY initially attempted to discourage her from pursuing a degree in hard sciences, incorrectly believing that a blind person
could not succeed in such a program, Ms. Resnick not only demonstrated that she could meet the demands of the course work,
but she graduated with honors. She then went on to obtain a Masters of Science in biopsychology from Rensselaer Polytechnic
Institute in 1993. And in 2004, Ms. Resnick obtained a Healthcare Provider CPR/AED Certification from the American Heart
Association.

“It has been my lifelong dream to become a nurse and I have worked very hard to get here,” said Melissa Resnick. “I
purposely took difficult courses in school and volunteered at a hospital just to be overqualified for nursing school. I am
confident that I will succeed and I thank Nassau Community College for giving me this opportunity.”

With more than 50,000 members, the National Federation of the Blind is the largest and most influential membership
organization of blind people in the United States. The NFB improves blind people’s lives through advocacy, education,
research, technology and programs encouraging independence and self-confidence. It is the leading force in the blindness
field today and the voice of the nation’s blind. The NFB headquarters has been located in Baltimore, Md., since 1978. In
January 2004, the NFB opened the NFB Jernigan Institute, a $20 million, 188,000-square-foot research and training facility
adjacent to its headquarters in South Federal Hill.

Contacts:

Linda J. McCarty
National Federation of the Blind
(410) 659-9314, ext. 2220
(410) 340-0475 cell

Patricia Maurer
National Federation of the Blind
(410) 659-9314, ext. 2272

Reginald Tuggle
Nassau Community College
(516) 572-7250
National Federation of the Blind

Preclinical testing has begun on the novel glaucoma treatment recently licensed by
Advanced Refractive Technologies (OTC Bulletin Board: ARFR). This first
step in clinical trials will assess the safety and efficacy of the compound
before the initiation of human trials. The in vitro portion of this testing
will require approximately six months to complete at which time the in vivo
testing will begin. After six months of this in vivo testing, the Phase One
human trials should be underway.

This compound, derived from monoclonal antibodies, works specifically
on one structure of the eye, known as Schlemm’s Canal, in order to improve
the outflow of fluid in the eye. Glaucoma is caused by an increase of
pressure within the eye and can be controlled by either reducing the inflow
of aqueous humor into the eye or increasing the outflow.

Randy Bailey, President and CEO of ART, states, “The most intriguing
aspect of this compound is that it may change the paradigm of glaucoma
treatment which has traditionally been a daily treatment with drops. This
new drug may have the possibility of as few as two treatments per year for
the patient. If this proves to be true, the problem of patient compliance
will be a thing of the past.”

Glaucoma is a serious and common eye disease. A recent study published
by authors from the Wilmer Ophthalmological Institute at Johns Hopkins
University stated that there will be 60.5 million people worldwide with the
two most common kinds of glaucoma in 2010 and that number will rise to 79.6
million by 2020.

“The goal of this technology is to specifically target the diseased
tissue in glaucoma with therapeutics to more effectively lower intraocular
pressure,” said W. Daniel Stamer, PhD. Dr. Stamer is a recognized expert in
glaucoma research, having many awards and publications in the area of
intraocular pressure regulation. “Our technology is designed to flush out
debris that inappropriately accumulates in the drain part of glaucomatous
eyes and restore intraocular pressure back to normal levels.”

“Dr. Stamer’s approach offers a new way to control intraocular pressure
in the management of glaucoma and we look forward to his progress. His
unique technology will be a welcome addition and should see broad
acceptance,” said Richard H. Keates, MD, Chairman of the Board of ART.

About Advanced Refractive Technologies, Inc.

Advanced Refractive Technologies, Inc. is an ophthalmology development
company focused on the development and marketing of innovative ophthalmic
applications that will result in faster, safer and more effective
procedures in two of the largest surgical markets in the world: corrective
refractive surgery and cataract surgery, as well as innovative drugs for
glaucoma and age-related macular degeneration. Advanced Refractive
Technologies is currently in the process of developing their Accupulse, a
next generation cataract emulsifier, which utilizes the company’s
proprietary waterjet technology. The Accupulse cataract emulsifier,
currently under development, is a device that uses pulsed waterjet
technology to remove cataracts — the most frequently performed surgical
procedure in the world. For more information on Advanced Refractive
Technologies, please visit its website at
advancedrefractive.

Advanced Refractive Technologies, Inc.
advancedrefractive

The London Eye Hospital, the UK’s leading centre for premium lens implants, has today completed the world’s first bi-focal Light Adjustable Lens (LAL) eye surgery, apart from clinical trials. Typically used during cataract or clear lens extraction surgery, LALs are the only lenses that can be adjusted after they’re implanted in the eye.

The new bifocal LALs consist of unique materials called ‘macromers’ which were developed in the USA by a team of Nobel Prize winning scientists. Using this advanced technology, a surgeon can adjust the power of the lens with amazing precision, and can therefore correct both long and short sight – permanently – on each bifocal lens.

The procedure was performed by Mr Bobby Qureshi, BSc MBBS FRCS (Ophth.), Consultant Ophthalmic Surgeon and Medical Director at The London Eye Hospital (LEH). LEH surgeons have already implanted over 10,000 lenses of various designs in the UK, and have helped thousands of people to banish their glasses and contact lenses for good. In fact, it was Mr Qureshi who performed the first LAL implants in the UK, and he is the only Consultant Ophthalmic Surgeon able to perform this new bifocal LAL surgery in the UK.

“Because these new bifocal LALs make use of the latest nanotechnology at a molecular level, they truly represents a whole new level in lens implant technology,” says Bobby Qureshi, Consultant Ophthalmic Surgeon and Medical Director at The London Eye Hospital. “Before, a single Light Adjustable Lens could be adjusted to improve either short or long distance, but this new bifocal LAL can actually provide both – in a single lens – offering high-definition near and far vision.”

The digital adjustments made possible with a bifocal LAL are carried out by a computer-controlled, low-intensity beam of light, and thus do not carry the risks and complications normally associated with surgery. Also, unlike all other surgical techniques available for correcting reading vision, the LAL can be adjusted more than once without surgery to give the optimal result for each individual eye.

The lens adjustments made possible with a bifocal LAL are so accurate that they have the potential to correct even minor imperfections, thereby giving patients the so-called ‘high definition’ vision that has been widely reported in both the UK and US media. Also, because the lens can now provide bifocal vision in both eyes, it can finally give patients total freedom from their glasses, even if they currently use two different pairs.

Even more remarkable is that a bifocal LAL will last forever, and will never need to be removed or replaced. Likewise, any adjustments to the lens are also permanent and – after they have been optimised for a patient’s particular vision – will never need to be readjusted. Mr Qureshi has already performed more LAL operations than any other surgeon in the world and he is looking forward to offering this technological advancement to his patients who come from worldwide to have treatment at the London Eye Hospital.

For more information please visit londoneyehospital or call 0800 612 2021.

Source:
London Eye Hospital

Children with cerebral palsy and other neurological problems often have extremely poor eyesight. Their ability to read, pick up objects and “see” the world is so impaired and complicated to treat that many go untreated, even though they may be legally blind.

Janice Brunstrom, M.D., assistant professor of neurology and pediatrics at Washington University School of Medicine in St. Loius and a neurologist at St. Louis Children’s Hospital, saw firsthand how her patients’ poor vision interfered with every aspect of their daily lives. Having cerebral palsy herself and wanting to help reverse the isolation that many of these children endure because of their poor vision, she approached pediatric ophthalmologist Lawrence Tychsen, M.D., to help devise some solutions.

He did. Tychsen, professor of ophthalmology and visual sciences, of pediatrics and of neurobiology and ophthalmologist in chief at St. Louis Children’s Hospital, developed specialized testing and now does vision correction, or refractive surgery, on children with cerebral palsy, Down syndrome and neurobehavioral disorders such as autism. To date, St. Louis Children’s Hospital is one of the only U.S. medical centers performing refractive surgery on these children and has the highest volume, operating on about 60 special-needs children a year.

“We work with the most profoundly impaired children who are the most difficult to examine,” says Tychsen, also professor of anatomy and neurobiology and of pediatrics. “So we tend to have the most grateful parents, too.”

When Brunstrom talked with Tychsen about repairing the vision in these children, he readily agreed and made room for them in his busy clinical schedule.

“These are kids who were legally blind and whom everyone had given up on,” Brunstrom says. “One by one, he has restored their sight by going through every detail and figuring out what is wrong and what he can fix. He is willing to tackle situations that used to be considered impossible or not worth the time.”

The children who are the best candidates for vision correction surgery are those who cannot or will not wear glasses and have blunted social interactions or fearfulness because of their visual impairment. Tychsen says that these children suffer a kind of “visual autism.” About 80 percent of children with severe neurological disorders have some kind of vision impairment. About 10 percent have a severe impairment.

Tychsen and his staff perform laser-assisted subepithelial keratectomy, or LASEK, in which the cornea is reshaped with a laser. This technique doesn’t require a surgical flap to be cut in the eye and is safer for children, who will inevitably rub their eyes after surgery. In addition, the LASEK technique is able to correct much higher degrees of myopia, or nearsightedness, than the LASIK technique (laser-assisted in situ keratomileusis) commonly used on adults. The surgeons can also correct extreme farsightedness.

For children with focusing defects so large that they are beyond the range of laser correction, Tychsen uses other surgical techniques. One of these is implantation of a phakic intraocular lens, leaving the natural lens in place. The other is a lens extraction technique, in which the natural eye lens is removed and replaced with another type of implant. These techniques can improve vision in a child with profound nearsightedness, such as 20/1,500, to nearly 20/20, Tychsen says.

Most of these children also have other factors affecting their vision, such as crossed eyes, wiggling eyes or a structural anomaly. In those cases, refractive surgery alone can’t correct their vision to 20/20, but when combined with eye muscle surgery or other procedures, it can considerably improve vision.

Because many of the children Tychsen treats are unable to communicate clearly or are uncooperative, he and his team use several noninvasive, electronic techniques to measure eyesight and determine the success of surgery. A computer-recording method measures the improvements that can be achieved in the visual brain while the child is awake. Other instruments take precise measurements before surgery while a child is under anesthesia.

Although the surgeries can make significant improvements in the child’s vision and overall quality of life, most laser-treated children will see mild regression in their vision over time and about 10 percent require repeat surgery, Tychsen says. But for most parents, the decision to have their child go through the surgery is relatively simple.

“For special-needs children, there is often no alternative,” Tychsen says. “They cannot or will not wear glasses and are unsuitable for contacts. When contemplating what it could mean to the overall development of the child, most parents opt for surgery.”

Julie Lawrence is one of Tychsen’s patients whose life has changed significantly since she had vision correction surgery about three years ago, says her mother, Greta Lawrence. Julie has Angelman Syndrome, a chromosomal disorder, and was extremely nearsighted with astigmatism.

Because of her autistic tendencies and poor vision, Julie would withdraw into herself. Tychsen often reminded the Lawrences that Julie needed vision correction to become interested in things and engaged in the world. However, Greta Lawrence says some of Julie’s other doctors discouraged them from having the surgery.

“Because she can’t read or do academics, some doctors said it wasn’t worth it,” Greta Lawrence says tearfully. “But Dr. Tychsen always treated her like she was important and thought it would be worthwhile.”

The Lawrences eventually decided to have Tychsen perform the vision correction surgery and noticed changes in Julie right away.

“When we drove home from hospital, she started noticing all the cars around her,” Greta Lawrence says. “She didn’t realize that when you are on the road there are other cars around. Although she doesn’t talk, she was laughing and looking at everything.”

Greta Lawrence says since the surgery, which corrected Julie’s vision to “almost perfect,” Julie can now recognize her family from across the room, she can walk and go up and down stairs better and is less restless when in public. “She’s more content to sit and watch what people are doing. If she couldn’t see, she wouldn’t be doing that.”

Washington University School of Medicine’s full-time and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is one of the leading medical research, teaching and patient care institutions in the nation, currently ranked fourth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.

Contact: Beth Miller

Washington University School of Medicine

Biliopancreatic diversion surgery for morbid obesity is known to cause multiple vitamin deficiencies that may worsen during pregnancy. In the June issue of the Journal of AAPOS, the Official Publication of the American Association for Pediatric Ophthalmology and Strabismus, a group of Australian clinicians report a child who was born blind as a result of Vitamin A deficiency caused by his mother’s obesity surgery.

Clinical investigators from Australia documented the case of a woman who had undergone biliopancreatic diversion surgery for obesity 7 years before the birth of her child. At 9 weeks gestation, the mother was diagnosed with severe deficiencies of Vitamins A, D and K, as well as iron-deficiency anemia, which had been undetected prior to this point. Despite treatment, her serum vitamin A level remained critically low throughout the pregnancy. Her infant son had significant malformations of both eyes, and his vision remains poor despite treatment. For the fetus, the first 8 weeks of gestation are the most critical time for organs to develop, including the formation of the visual system,

Lead investigator Glen Gole, MD, FRANZCO, Department of Ophthalmology, Royal Children’s Hospital and Discipline of Paediatrics and Child Health, University of Queensland, Brisbane, states, “The mother’s description of night blindness, recurrent low vitamin A levels during the pregnancy, and demonstrated vitamin A deficiency in the neonate support vitamin A deficiency as the cause. This case illustrates that vitamin A is very important for normal eye development in the fetus, particularly for pregnant women who have undergone gastric bypass surgery in order to improve their fertility.”

Commenting on the article, J AAPOS Editor-in-Chief David G. Hunter, MD, PhD, stated, “Weight-reduction surgery is becoming more common, especially with the potential for health benefits that result from reducing obesity. Unfortunately some forms of this surgery cause vitamin deficiency, and in this case the problem led to a birth defect that caused blindness in one child. We are not aware of any other cases of this particular problem, but it is important for any woman who has had this form of gastric bypass surgery to be checked for vitamin deficiency–and have it corrected-before considering having a baby.”

The article is “Ocular malformation in a newborn secondary to maternal hypovitaminosis A” by Hannah Gilchrist, MBBS, Deepa A. Taranath, MS, FRANZCO, and Glen A. Gole, MD, FRANZCO. It appears in the Journal of AAPOS, Volume 14, Issue 3, (June 2010) published by Elsevier. doi:10.1016/j.jaapos.2010.01.015

Source:

Elsevier