Month: July 2014

Results from a Phase 3 study demonstrate
MACUGEN® (pegaptanib sodium) significantly improved vision in
patients with diabetic macular edema (DME), a complication of
diabetes that is a leading cause of blindness in people of
working age.(1) In the study, 37 percent of patients treated
with MACUGEN gained two lines, or 10 letters, of vision on the
ETDRS eye chart at 54 weeks, compared to 20 percent of patients
who received a sham (placebo-like) procedure which consists of
anesthesia and a simulated injection in the eye (p=0.0047). The
data were presented today at the World Ophthalmology Congress in
Berlin by Frank G. Holz, an investigator in the trial and
director of the University Eye Hospital at the University of Bonn
in Germany.

“These encouraging Phase 3 results demonstrate that MACUGEN has
the potential to improve vision in people with DME, a serious
complication of chronic diabetes,” said Marla B. Sultan, M.D.,
M.B.A., global clinical lead for MACUGEN at Pfizer. “Currently
there are no approved pharmaceutical treatments for DME, and when
untreated, about one out of four people with this condition
will develop moderate vision loss within three years,” said Dr.
Sultan. “Pfizer is pleased to be exploring MACUGEN as a
potential treatment option to address this unmet medical need.”
The phase 3 trial met its primary endpoint of the proportion of
patients gaining greater than ten letters vs sham at one year.
On average, patients treated with MACUGEN gained 5.2 letters of
vision at year one compared to 1.2 letters for patients receiving
sham (p

The Glaucoma Research Foundation (GRF) announced that Dennis Singleton is the 2009 recipient of its Visionary Award. Mr. Singleton, a long-time member of the GRF board, is being honored for his dedication to the cause of glaucoma research and education.

His vision for the future helped guide the development of the Foundation’s strategic plan and he led a successful capital campaign conducted by GRF to fund the plan.

Mr. Singleton has served on the Board of Directors for the Glaucoma Research Foundation since 1998, and served as Board Chairman from July 2003 through June 2006. Under his leadership, the Foundation realized its greatest growth in contributed income and the 3-year Catalyst For a Cure Campaign he led exceeded its revenue goal of $7.5 million raising a total of $8.6 million to support glaucoma research.

Singleton was presented the award by last year’s Visionary and founder of the Glaucoma Research Foundation, John Hetherington, MD, Clinical Professor of Ophthalmology at the University of California San Francisco.

The Visionary Award also recognizes Mr. Singleton’s philanthropic generosity as one of the Glaucoma Research Foundation’s most generous contributors. As Chair of the Strategic Planning Committee, he led the creation of the plan in 2007, and he continues to guide the Foundation’s course to achieve its strategic objectives.

“Dennis took office as Board Chair shortly after I joined GRF in 2003,” said Thomas M. Brunner, GRF President and CEO, “and his leadership provided a wonderful opportunity to learn from him and work together towards a greater vision for the Glaucoma Research Foundation.”

Mr. Singleton was Vice Chairman of Spieker Properties, Inc., a real estate investment trust, from 1998 until 2003, and served as Executive VP and CIO of that company from 1993 to 1997. He was a founding partner in 1987 and began his career in real estate with the Trammell Crow Company in 1972. Mr. Singleton has overseen the development and acquisition of more than 28,000,000 square feet of commercial properties representing an investment of over $3 billion. Mr. Singleton received a Bachelor of Science from Lehigh University and a Masters in Business Administration from Harvard Graduate School of Business Administration.

Source
Glaucoma Research Foundation

Testing the eyes of preterm children when they reach 2.5 years of age may predict vision problems at age 10, according to a report in the November issue of Archives of Ophthalmology, one of the JAMA/Archives journals.

“Ophthalmological studies of preterm (prematurely born) children have resulted in recommendations that they need follow-up examinations, to find those in need of extra help,” the authors provide as background information in the article. “However, such follow-up programs are expensive and must be based on accurate knowledge of the prevalences of ophthalmological disorders in preterm and full-term children.” Previous studies have found that refractive errors, or errors in the degree of light that reaches the back of the eye, are more common in preterm children (born before 35 weeks gestation) than full-term children.

Eva K. Larsson, M.D., Ph.D., and colleagues at Uppsala University Hospital, Sweden, performed retinoscopies–tests for refractive errors that involve examining the back of the eye–in 198 preterm children at 6 months, 2.5 years and 10 years of age. The investigators assessed the development of astigmatism, an unequal curve in one of the eye’s refractive surfaces, and anisometropia, a difference in refractive power between the two eyes that can lead to partial vision loss.

The prevalence and degree of astigmatism declined between 6 months and 2.5 years and then remained stable through 10 years; 108 children had astigmatism at six months, 54 at 2.5 years and 41 at 10 years. The amount of anisometropia in the entire group showed no change between 6 months and 2.5 years of age but increased between 2.5 and 10 years. The prevalence, however, remained stable: 15 children had anisometropia at 6 months, 17 at age 2.5 and 16 at age 10. “The presence of astigmatism and anisometropia at 2.5 years of age were the strongest risk factors for having astigmatism and anisometropia at 10 years of age,” the authors write.

“In this population-based study, we found that a refractive error at 2.5 years of age predicts that refractive error will also be present at 10 years of age,” they conclude. “Recommendations for follow-up examinations must include all aspects of visual function, i.e., visual acuity, contrast sensitivity and visual fields, as well as the refraction, strabismus and perceptual problems. All preterm children should be included in such follow-up examinations for refractive error, irrespective of the retinopathy of prematurity stage,” or the degree to which blood vessels in the retina have developed abnormally because of preterm birth.

(Arch Ophthalmol. 2006;124:1608-1614.)

This study was supported by Stiftelsen Synframjandets Foundation for Research and the Crown Princess Margaretha Foundation for Visually Impaired. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Eva K. Larsson

JAMA and Archives Journals

Over the past ten years the European Blind Union has been working to improve travel by air for blind and partially sighted, deaf blind and blind people with additional disabilities. As a result of our work, we are pleased to inform you that from 26 July 2008, the new Air Regulations come into operation at all airports throughout Europe.

To ensure these regulations work, we need your help in monitoring them at your local airport, to find out if they have in place, their staff with disability awareness training.

This must include the special requirements of training staff in the needs of blind and partially sighted people, which should include guiding a blind person, making sure that a wheelchair is not offered as an automatic help but only offered if the blind person has difficulty in walking.

Following are the parts of the regulations that you need to be aware of, and which we would like you to monitor for us. If you require a full set of the regulations they will be available from the Federation’s office, address as above.

This summary is based on Regulation (EC) No 1107/2006 of the European Parliament and of the Council of 5 July 2006 concerning the rights of disabled persons and persons with reduced mobility when travelling by air.

Disabled persons and persons with reduced mobility have the same right as all other citizens to free movement, freedom of choice and non-discrimination. This applies to air travel as to other areas of life.

Disabled persons and persons with reduced mobility should therefore be accepted for carriage and not refused transport on the grounds of their disability or lack of mobility, except for reasons which are justified on the grounds of safety and prescribed by law. Before accepting reservations from disabled persons or persons with reduced mobility, air carriers, their agents and tour operators should make all reasonable efforts to verify whether there is a reason which is justified on the grounds of safety and which would prevent such persons being accommodated on the flights concerned.

In order to give disabled persons and persons with reduced mobility opportunities for air travel comparable to those of other citizens, assistance to meet their particular needs should be provided at the airport as well as on board aircraft, by employing the necessary staff and equipment. In the interests of social inclusion, the persons concerned should receive this assistance without additional charge.

Assistance given at airports situated in the territory of a Member State to which the Treaty applies should, among other things, enable disabled persons and persons with reduced mobility to proceed from a designated point of arrival at an airport to an aircraft and from the aircraft to a designated point of departure from the airport, including embarking and disembarking. These points should be designated at least at the main entrances to terminal buildings, in areas with check-in counters, in train, light rail, metro and bus stations, at taxi ranks and other drop-off points, and in airport car parks. The assistance should be organised so as to avoid interruption and delay, while ensuring high and equivalent standards throughout the Community and making best use of resources, whatever airport or air carrier is involved.

To achieve these aims, ensuring high quality assistance at airports should be the responsibility of a central body. As managing bodies of airports play a central role in providing services throughout their airports, they should be given this overall responsibility.

Managing bodies of airports may provide the assistance to disabled persons and persons with reduced mobility themselves. Alternatively, in view of the positive role played in the past by certain operators and air carriers, managing bodies may contract with third parties for the supply of this assistance.

In deciding on the design of new airports and terminals, and as part of major refurbishments, managing bodies of airports should, where possible, take into account the needs of disabled persons and persons with reduced mobility. Similarly, air carriers should, where possible, take such needs into account when deciding on the design of new and newly refurbished aircraft.

All essential information provided to air passengers should be provided in alternative formats accessible to disabled persons and persons with reduced mobility, and should be in at least the same languages as the information made available to other passengers.

Where wheelchairs or other mobility equipment or assistive devices are lost or damaged during handling at the airport or during transport on board aircraft, the passenger to whom the equipment belongs should be compensated, in accordance with rules of International, Community and National Law.

Complaints concerning assistance given at an airport should be addressed to the body or bodies designated for the enforcement of this Regulation.

Member States should lay down penalties applicable to infringements of this Regulation and ensure that those penalties are applied. The penalties, which could include ordering the payment of compensation to the person concerned, should be effective, proportionate and dissuasive.

An air carrier or its agent or a tour operator shall not refuse, on the grounds of disability or of reduced mobility, to accept a reservation for a flight departing from or arriving at an airport to which this Regulation applies.

An air carrier or its agent shall make publicly available, in accessible formats and in at least the same languages as the information made available to other passengers, the safety rules that it applies to the carriage of disabled persons and persons with reduced mobility, as well as any restrictions on their carriage or on that of mobility equipment due to the size of aircraft.

A tour operator shall make such safety rules and restrictions available for flights included in package travel, package holidays and package tours which it organises, sells or offers for sale.

The managing body of an airport shall, taking account of local conditions, designate points of arrival and departure within the airport boundary or at a point under the direct control of the managing body, both inside and outside terminal buildings, at which disabled persons or persons with reduced mobility can, with ease, announce their arrival at the airport and request assistance.

The points of arrival and departure shall be clearly signed and shall offer basic information about the airport, in accessible formats.

Air carriers, their agents and tour operators shall take all measures necessary for the receipt, at all their points of sale in the territory of the Member States to which the Treaty applies, including sale by telephone and via the Internet, of notifications of the need for assistance made by disabled persons or persons with reduced mobility.

When an air carrier or its agent or a tour operator receives a notification of the need for assistance at least 48 hours before the published departure time for the flight, it shall transmit the information concerned at least 36 hours before the published departure time for the flight: (a) to the managing bodies of the airports of departure, arrival and transit, and (b) to the operating air carrier, if a reservation was not made with that carrier, unless the identity of the operating air carrier is not known at the time of notification, in which case the information shall be transmitted as soon as practicable.

As soon as possible after the departure of the flight, an operating air carrier shall inform the managing body of the airport of destination, if situated in the territory of a Member State to which the Treaty applies, of the number of disabled persons and persons with reduced mobility on that flight requiring assistance and of the nature of that assistance.

When a disabled person or person with reduced mobility arrives at an airport for travel by air, the managing body of the airport shall be responsible for ensuring the provision of the assistance in such a way that the person is able to take the flight for which he or she holds a reservation, provided that the notification of the person’s particular needs for such assistance has been made to the air carrier or its agent or the tour operator concerned at least 48 hours before the published time of departure of the flight. This notification shall also cover a return flight, if the outward flight and the return flight have been contracted with the same air carrier.

Where use of a recognised assistance dog is required, this shall be accommodated provided that notification of the same is made to the air carrier or its agent or the tour operator in accordance with applicable national rules covering the carriage of assistance dogs on board aircraft, where such rules exist.

If no notification is made, the managing body shall make all reasonable efforts to provide the assistance in such a way that the person concerned is able to take the flight for which he or she holds a reservation.

The assistance provided shall, as far as possible, be appropriate to the particular needs of the individual passenger.

Air carriers and airport managing bodies shall ensure that all their personnel, including those employed by any sub-contractor, providing direct assistance to disabled persons and persons with reduced mobility have knowledge of how to meet the needs of persons having various disabilities or mobility impairments. They should also provide disability-equality and disability-awareness training to all their personnel working at the airport who deal directly with the travelling public, including that upon recruitment, all new employees attend disability-related training and that personnel receive refresher training courses when appropriate.

National Federation of the Blind of the UK
nfbuk

Dr. Dimitri Azar, B.A. Field Endowed Chair of Ophthalmologic Research at the University of Illinois at Chicago College of Medicine, is the 2009 recipient of the Lans Distinguished Award from the International Society of Refractive Surgery of the American Academy of Ophthalmology.

The award is given to leaders in the field of refractive, cornea, cataract and lens-based surgery. It is named for Leedert J. Lans, a renowned ophthalmology researcher who defined the basics of refractive surgery — surgery that corrects problems of visual acuity.

Azar has made significant contributions to the treatment of corneal diseases and refractive surgery through sophisticated analysis and application of advanced optics. His research has resulted in better understanding of corneal wound healing, the applications and complications of laser keratectomy (corneal surgery), and the molecular organization of the normal and injured cornea.

Azar became professor and head of ophthalmology and visual science at UIC in 2006, coming from the faculty of Harvard Medical School. He was named a University Scholar earlier this year. He has published more than 177 peer-reviewed articles, more than 185 other articles and book chapters, and well over 100 abstracts. He is the editor or co-editor of 14 books on cornea and refractive surgery.

Azar has taught and mentored more than 80 research and clinical fellows in cornea, external diseases and refractive surgery and countless residents. In addition, he has pioneered novel approaches to ophthalmology continuing education — developing the Illinois Eye Review, an annual course introduced in 2008.

U.S. News and World Report ranked The Illinois Eye and Ear Infirmary of the University of Illinois Medical Center one of America’s Best Hospitals for Ophthalmology.

The International Society of Refractive Surgery of the American Academy of Ophthalmology is the leading organization for refractive surgeons, with members in more than 80 countries. The award will be presented at the society’s gala at the American Academy of Ophthalmology’s joint meeting Oct. 23 in San Francisco.

Source
University of Illinois at Chicago

Alimera Sciences, Inc., a privately
held biopharmaceutical company that specializes in the research,
development and commercialization of prescription ophthalmic
pharmaceuticals, reported the interim month three safety and efficacy
results from the first human pharmacokinetic (PK) study of Medidur(TM) FA,
which Alimera Sciences intends to market under the tradename Iluvien(TM),
if approved by the U.S. Food and Drug Administration.

This 36-month, open-label Phase 2 study, running concurrently with the
pivotal Phase 3 FAME(TM) Study (Fluocinolone Acetonide in Diabetic Macular
Edema), is designed primarily to assess systemic exposure of the
corticosteroid, fluocinolone acetonide (FA), after administration of
Iluvien in diabetic macular edema (DME) patients. Secondarily, the study is
designed to provide information on the safety and efficacy of Iluvien in a
DME population. A total of 37 subjects were enrolled in this trial, 20
patients on the low dose (an approximate 0.23 microgram per day dose) of
Iluvien, and 17 patients on the high dose (an approximate 0.45 microgram
per day dose) with the same inclusion/exclusion criteria as the ongoing
Phase 3 FAME Study.

Iluvien is an intravitreal insert being developed for the treatment of
DME. DME is a disease of the retina, which affects individuals with
diabetes and can lead to severe vision loss and blindness. Each Iluvien
insert is designed to provide a sustained therapeutic effect, up to 24
months for the low dose and up to 36 months for the high dose. Iluvien is
inserted into the patient’s eye with a 25-gauge needle, which allows for a
self-sealing wound. This insertion is very similar to an intravitreal
injection, a procedure commonly employed by retinal specialists.

This three-month interim readout from the PK Study indicated 20 percent
of the low dose patients and 18 percent of the high dose patients showed an
improvement in best-corrected visual acuity (BCVA) of 15 letters or greater
from baseline. In addition, both the low dose and the high dose of Iluvien
resulted in a significant reduction in retinal thickness as compared to the
baseline.

From a safety perspective, no adverse events related to intraocular, or
inner eye, pressure were seen in the low dose patients, while 12 percent of
the high dose patients experienced intraocular pressure increases of
greater than 30 mmHg. Additionally, the only adverse event related to
cataract formation was reported in a patient in the high dose group.

The early readout from this PK Study provides further insight into the
dose-response of FA in the treatment of DME. By comparison, Bausch & Lomb’s
Retisert(R) (fluocinolone acetonide intravitreal implant), with an initial
release dose of 0.6 microgram per day, was also studied in a DME
population. It demonstrated a significant improvement in visual acuity at
one year, comparable to the Iluvien results reported here; however, a lower
dose was not tested. Therefore, it has not been determined if Retisert’s
dosage level represents the lowest efficacious dose for DME.

“We believe this early readout from our PK Study supports our premise
that lower doses of FA delivered by Iluvien will provide visual acuity
improvements while reducing the risk of ocular side effects commonly
associated with the use of corticosteroids,” said Ken Green, Ph.D., chief
scientific officer for Alimera.

Data from this open-label study will be evaluated on an ongoing basis
with interim looks at months 3, 6, 12, 18, 24, 30 and 36. Except for the
month 12 and final month 36 looks, when the database will be fully locked,
interim evaluations will be based on unaudited data. The last patient was
enrolled in this study at the end of February 2007.

About Alimera Sciences, Inc.

Alimera Sciences is a biopharmaceutical company that specializes in the
research, development and commercialization of prescription ophthalmic
pharmaceuticals. Presently the company is focused on diseases affecting the
back of the eye, or retina. Its most advanced product candidate is
Iluvien(TM), which is being developed for the treatment of diabetic macular
edema, or DME. DME is a disease of the retina, which affects individuals
with diabetes and can lead to severe vision loss and blindness. Under one
protocol, enrollment was completed in October 2007 in two Phase 3 pivotal
trials for the use of Iluvien in the treatment of DME conducted across the
U.S., Canada, Europe and India, with a combined total enrollment of 956
patients.

Alimera also has entered into an exclusive worldwide agreement with
Emory University to explore oxidative stress management — specifically the
reduction of reactive oxygen species (ROS) — as a treatment strategy for
ophthalmic diseases. Under this agreement, Alimera has the exclusive option
to license compounds, which are NADPH (nicotinamide adenine dinucleotide
phosphate reduced form) oxidase inhibitors, as potential treatments for
conditions such as the dry form of age-related macular degeneration (AMD),
particularly the late stage of this condition known as geographic atrophy.
Alimera retains the right to use the Medidur(TM) delivery system for two of
these compounds, and is also exploring other delivery technologies to apply
to these compounds.

Alimera Sciences, Inc.
alimerasciences

This month’s Ophthalmology, the journal of the American Academy of Ophthalmology, includes results from a large Kaiser Permanente study of age-related macular degeneration (AMD) treatments, the first global report on retinal vein occlusion, and new recommendations to help elders with vision loss avoid falls.

Kaiser Study Compares Effectiveness of Two AMD Drugs

A Kaiser Permanente Southern California study compared two very similar medications – ranibizumab and bevacizumab – used to treat “wet” AMD and found the two equally effective at halting vision loss. Because many Americans will soon be 65 or older and AMD incidence rises sharply with age, the disease is becoming an urgent concern for the healthcare system. Donald S. Fong, MD, MPH, and his Kaiser colleagues followed 324 newly-diagnosed AMD patients treated with bevacizumab and 128 treated with ranibizumab between 2005 and 2008. Visual acuity improved and stabilized in both patient groups: the proportion of patients who had 20/40 vision or better increased from 13.6 percent at baseline to 22.9 percent at 12 month follow-up in bevacizumab-treated patients and from 11.7 percent to 25.0 percent in ranibizumab-treated patients.

Ranibizumab (Lucentis) was specifically developed to treat the wet (neovascular) form of AMD and received U.S. Food and Drug Administration (FDA) approval in 2006; bevacizumab (Avastin) was originally approved by the FDA as a cancer treatment and was used “off label” by ophthalmologists before Lucentis became available. Since Avastin appears to be beneficial and costs significantly less per dose than Lucentis, ophthalmologists continue to use it. Several comparative studies of the two drugs are underway, in relation to efficacy, safety, treatment protocols and cost-effectiveness. Results of the Comparisons of Age-Related Macular Degeneration Treatments Trials (CATT), a randomized clinical trial involving 44 centers across the U.S. and funded by the National Eye Institute, are likely to be particularly important.

“Some physicians are concerned about the effectiveness of Avastin, but our data did not seem to show any difference,” Dr. Fong said. “Our results illustrate real-world use of AMD treatments: at the time of our study, there was no universal agreement within our 11 centers on optimal protocols, so treatment intervals and the drug selected for use depended on doctor-patient preference,” he added.

First Report on Worldwide Prevalence of Retinal Vein Occlusion

Ophthalmologists recognize retinal vein occlusion (RVO), commonly called “eye stroke,” as a serious disease and significant cause of blindness. Surprisingly, the magnitude of the problem had been unclear prior to this first report on worldwide RVO prevalence by the International Eye Disease Consortium (IEDC). Based on data from 15 major population studies in the United States, Europe, Asia and Australia, the IEDC estimates that globally, 16.4 million adults are affected by RVO. For comparison, more than 131 million adults with diabetes worldwide either have diabetic retinopathy or are at risk of developing this potentially blinding disease, according to a 2005 World Health Organization report.

In central and branch retinal vein occlusion (CRVO and BRVO), vision impairment and eye damage occur when the vein becomes blocked, usually by a blood clot. This leads to reduced blood flow, hemorrhage and/or swelling in the retina, the light-sensitive tissue at the back of the eye that receives images and relays them to the optic nerve. An estimated 13.9 million people worldwide are affected by BRVO, and 2.5 million by CRVO, the IEDC report found. Prevalence is similar in men and women and increases with age, probably because of age-related increases in arteriosclerosis, hypertension and glaucoma or elevated intraocular pressure. Although BRVO prevalence appears to be highest in Asians and Hispanics and lowest in whites, the authors say this may reflect varying methodologies or definitions among reviewed studies rather than true ethnic differences.

“We need to understand how hypertension and other cardiovascular risk factors impact BRVO and CRVO, and how glaucoma impacts CRVO, in various ethnic groups and populations so that appropriate preventive and treatment strategies can be designed,” said Tien Y. Wong, MD., PhD, lead investigator for the IEDC.

Central and Side Vision Factor into Older Americans’ Risk of Falling

Each year, falls occur in 35 to 40 percent of people age 65 and older who are generally healthy and living independently. About half of all falls result in injury, and up to 18 percent of these injuries require medical care. It is well known that people with reduced central vision – the ability to see clearly in front of them – are more likely to fall. A new report from the Los Angeles Latino Eye Study (LALES) is the first to show the independent effects of impairment of central (CVI) and of peripheral vision (PVI).

CVI and PVI were measured for more than 3,200 LALES participants at the time each person joined the study, between 2000 and 2003. In participant reports gathered between 2004 and 2008, 19 percent reported falls and 10 percent falls with injury within the previous 12 months. The proportion of falls and falls with injury increased with the severity of CVI and PVI, suggesting cause-and-effect relationships. People with CVI were at 2.8 times’ higher risk for falls with injury than those with no visual impairment, and PVI increased the risk 1.4 times. Seventy percent of those with CVI also had PVI.

“The data strongly suggest that treating central vision alone may be insufficient to help prevent falls and falls with injury, and that older patients should also be screened and treated for PVI,” said lead researcher Rohit Varma, MD, MPH. “Also, we recommend advising patients aged 60 and older on their increased fall risk and the need to take extra precautions. Finally, since persons in our study with normal vision also experienced falls and related injuries, research is needed on other causes of this problem.”

Source:
Mary Wade
American Academy of Ophthalmology

View drug information on Avastin; Lucentis.

Many computing luminaries, such as Steve Jobs or Bill Gates, have an early experience in common–an engaging experience in middle school or high school that sparked an excitement for learning everything they could about computers. Today, many young people are surrounded by computing at home and in school, and some of them will likely find a similar passion that will lead them to push tomorrow’s frontiers in computer science.

For visually impaired students, however, the pathways to studying computer science are more complicated. While technologies can make it easier for them to use computers, the visual nature of modern computing makes it difficult for them to participate in programming courses and other types of computing instruction. These students also commonly lack the resources and preparation other students get in computing before they get to college, and there is a dearth of visually impaired role models in computing to inspire them as they pursue their degrees.

Enter Project Accessible Computing Education (ACE), an NSF-funded initiative at the Rochester Institute of Technology (RIT). The project is designed to help prepare visually impaired middle school and high school students participate in computer science programs at the collegiate level. Project ACE’s ultimate goal is to increase the number of visually impaired students pursuing degrees in computer science and give them the foundations they need to be fully successful in their studies and beyond.

According to Stephanie Ludi, a professor of software engineering at RIT and the principal investigator for the project, in the long run, encouraging these students will benefit everyone who uses a computer. “Because of the unique perspective they have,” Ludi said in an interview this month, “they can create software that is really more usable for everybody.”

The project is focused on three areas: better preparation for visually impaired students before college, support for these students as they face challenges in computing that other students do not, and educating teachers in how to best help these students learn and achieve.

Last year, the project conducted an interactive workshop for visually impaired students and their parents called ImagineIT. The four-day workshop, held at RIT’s B. Thomas Golisano College of Computing and Information Sciences, brought together more than a dozen visually impaired students and their parents from around the country and gave them an opportunity to tackle “real world” computing applications and learn about career opportunities in computing. The students worked collaboratively on a number of challenges, including building and programming Lego Mindstorm robots to interact with the environment by navigating through a maze to find a sound source.

According to Thomas Reichlmayr, also a professor of professors of software engineering at RIT and co-principal investigator on the project, the workshop was helpful for everyone. “It was a good opportunity for the students,” Reichlmayr said, “but also for their parents to network with other parents, to share experiences with their school districts and their own experiences as well.”

In addition to helping these young programmers gain a better appreciation for computer science, Project ACE also used the experience as a foundation for future workshops centered on preparing teachers to work with these students. Educators and students alike can go to the project’s Web site, se.rit.edu/~imagine-it/, and find lesson plans, tutorials and other resources.

Ludi says that Project ACE will repeat the ImagineIT workshop next year at RIT and also in Southern California.

In the next few years, the students from the first ImagineIT workshop will enter college. According to Ludi, some of them have already expressed interest in majoring in computer science.

NSF-PR 08-209

Source:
Dana W. Cruikshank
National Science Foundation

Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today it has reached agreement with the U.S. Food and Drug Administration (FDA) through a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical trial for Prolacria™ (diquafosol tetrasodium ophthalmic solution) 2% for the treatment of dry eye disease and has recently initiated enrollment in the trial.

Based on the SPA agreement, Inspire has initiated a Phase 3, randomized, placebo-controlled, environmental clinical trial to evaluate the efficacy and safety of Prolacria in approximately 450 subjects with dry eye who have a fluorescein staining score of three in the central region of the cornea at baseline, using the National Eye Institute (NEI) scale of zero to three. Subjects will be randomized to Prolacria or placebo administered as eye drops four times daily for six weeks at approximately 60 U.S. and Canadian sites.

The agreed upon primary efficacy endpoint is the proportion of subjects receiving Prolacria that achieve clearing of fluorescein staining of the central region of the cornea in the study eye (a score of zero on the NEI scale) at the six-week trial endpoint, compared to those receiving placebo. The FDA indicated, as part of the SPA review process, that even if this trial is successful, the FDA’s review of Prolacria will also take into account the robustness of the trial results, that a surrogate endpoint was used, the results from previous Prolacria trials and the overall risk/benefit.

Christy L. Shaffer, Ph.D., President and CEO of Inspire, commented, “We are pleased to have reached agreement with the FDA on the parameters for an additional Prolacria clinical trial. Our decision to continue development of Prolacria is based on a number of factors, including: the dry eye market is large and growing, with only one commercially available prescription product; our analysis of related Prolacria historical data in the central region of the cornea; and the length and estimated costs of this trial are reasonable relative to the financial opportunity.”

“We selected clinical trial sites and investigators experienced in conducting dry eye trials and evaluating dry eye patients using fluorescein staining procedures. We have worked closely with the sites to standardize the staining evaluation process,” Dr. Shaffer concluded.

Background materials related to the Prolacria program, including a summary presentation, scientific publications and patient enrollment information for the trial (Protocol 03-113), are available on Inspire’s website, inspirepharm.

About Dry Eye

Dry eye is a disease of the tears and ocular surface that leads to instability of the tear film, symptoms of discomfort and visual disturbance. The disease is usually characterized by either a decrease in tear production, which results in tear deficiency, or an imbalance in the composition of the tear film components, which leads to an unstable tear film and increased tear evaporation. If left untreated, dry eye disease can result in damage to the ocular surface and visual impairment.

About Prolacria™ (diquafosol tetrasodium ophthalmic solution) 2%

Prolacria is intended to stimulate release of the three natural tear components involved in tear secretion – mucin, lipids and fluid. Inspire filed a New Drug Application (NDA) for Prolacria for the treatment of dry eye with the FDA in 2003 and received an approvable letter in December 2003. Inspire submitted an amended NDA in June 2005 and the FDA issued an additional approvable letter in December 2005. In June 2001, Inspire and Allergan, Inc. entered into a joint license, development and marketing agreement to develop and commercialize Prolacria for dry eye disease worldwide, except Japan and nine other Asian countries. Inspire is responsible for conducting, in collaboration with Allergan, the Phase 3 clinical trials needed for potential FDA approval of Prolacria.

In December 1998, Inspire and Santen Pharmaceutical Co., Ltd. entered into a development, license and supply agreement for the development of diquafosol tetrasodium for the treatment of ocular surface diseases, such as dry eye, in Asia. Santen is responsible for developing and marketing diquafosol tetrasodium products in Japan and nine other Asian countries. Santen filed an application for manufacturing and marketing approval for its formulation of diquafosol tetrasodium, which Santen refers to as DE-089, with the Japanese Ministry of Health, Labor, and Welfare (the Japanese equivalent of the FDA) on May 30, 2008.

About Inspire

Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire is currently developing products for dry eye, cystic fibrosis and glaucoma. Inspire employs a U.S. sales force for the promotion of AzaSite® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis and Elestat® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis. Elestat and Prolacria are registered trademarks owned by Allergan, Inc. AzaSite is a registered trademark owned by InSite Vision Incorporated. For more information, visit inspirepharm.

Forward-Looking Statements

The forward-looking statements in this news release relating to management’s expectations and beliefs are based on preliminary information and management assumptions. Specifically, no assurances can be made with respect to: Inspire’s ability to enroll approximately 450 subjects in the new Phase 3 Prolacria trial or the timing associated with enrollment; the safety or efficacy of Prolacria in the trial or otherwise, including without limitation the ability to achieve the primary endpoint in the trial; the timing of randomization of patients into the trial; the number of clinical sites involved in the trial; the costs of the trial; the weight that the FDA will give to the robustness of the trial results, the fact that a surrogate endpoint is being used, the results from previous Prolacria trials, the overall risk/benefit of the candidate or any other factors in the FDA’s evaluation of Prolacria; growth, if any, of the dry eye market; the impact of dry eye disease, if left untreated, on the ocular surface and visual impairment of patients. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, intellectual property rights, adverse litigation developments, competitive products, results and timing of clinical trials, success of marketing efforts, the need for additional research and testing, delays in manufacturing, funding, and the timing and content of decisions made by regulatory authorities, including the U.S. Food and Drug Administration. Further information regarding factors that could affect Inspire’s results is included in Inspire’s filings with the SEC. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.

Inspire

View drug information on AzaSite.

Carl Zeiss Meditec is once again presenting its expanded offer of solutions for cataract, refractive and retina applications. Under the theme – Creating what’s to come – the company is demonstrating how it would like to shape the future of ophthalmology with its products and solutions.

The following will be on display at the 2010 ESCRS:

– ZEISS MICS Plattform – With the launch of the BLUEMIXSTM 180 injector for preloaded MICS IOLs, and the largest range of MICS IOLs on the market, OVDs and phaco technology, Carl Zeiss Meditec provides doctors with a total integrated product platform for micro-incision surgery.

– The future of the ZEISS toric solution – building on the existing ZEISS solution for the implantation of toric IOLs, the company is exhibiting the next generation with which toric intraocular lenses (IOLs) can be implanted and aligned as easily as standard IOLs.

– FORUM ready – All ophthalmic diagnostic instruments from Carl Zeiss shown at the ESCRS can be combined into one system with FORUM. The necessary DICOM interface is available as part of the “FORUM ready” offering. It allows doctors to optimize their workflows and data management and enables better data networking in the practice and the OR.

– VISULAS Trion VITE – The world’s only three-color laser that can apply multi-spot cascades and thus enable considerably gentler treatment of patients with retinal diseases.

“‘Creating what’s to come’ stands for our ambition to move forward with innovations, create something new and shape the future of ophthalmology and therefore medical progress. I am proud that we are able to once again exhibit many new innovations and our extensive product portfolio at the ESCRS,” states Dr. Ludwin Monz, President and CEO of Carl Zeiss Meditec AG.

Carl Zeiss Meditec supplies its customers with a unique ZEISS MICS platform that meets all the needs of micro-incision surgery.

The components of the ZEISS MICS platform at a glance:

– ZEISS MICS IOL portfolio – Carl Zeiss Meditec offers the largest range of MICS IOLs on the market – the right IOL for any eye.

– VISALIS: phaco technology from Carl Zeiss – with the VISALIS phaco technology as a component of the ZEISS MICS platform, Carl Zeiss provides optimized phaco handpieces and MICS-suitable fluidics to enable the smallest possible incision and good vacuum control.

– ZEISS OVDs – more than 25 years of experience in the development and manufacture of unique OVDs coupled with outstanding quality standards. Carl Zeiss offers a wide range of innovative OVDs ?�?�- the right product for any operation.

– BLUEMIXSTM 180 – introduced for the first time at the ESCRS, BLUEMIXS 180 is the first injector on the market for the largest range of preloaded MICS IOLs from Carl Zeiss. Doctors benefit from the improved safety and user-friendliness of the injector specially developed for MICS operations. With an incision of just 1.8 mm, they are able to obtain the best results. BLUEMIXS 180 guarantees the correct placement of the IOL and covers the entire diopter range of ZEISS MICS IOLs.

Building on the existing ZEISS solution for the implantation of toric IOLs, the company is exhibiting the future of the ZEISS toric solution: the optimization and simplification of the workflow for the implantation of toric IOLs will be demonstrated through the enhanced interaction of existing ZEISS products. For example, at the push of a button it will be possible to calculate toric IOLs without having to reenter the measured values and overlay the target axis in the microscope.

Carl Zeiss has also prepared a special ESCRS offer for its FORUM ready customers: ophthalmic diagnosis instruments will be delivered with a DICOM interface. This will enable them to combine instruments into one system that optimizes workflows and data management in the practice and the OR.

The new VISULAS Trion VITE laser optimally supplements the product line for retina treatment. The world’s only multi-wavelength laser that can apply multi-spot cascades, it enables improved results, shorter treatment times and increased treatment comfort.

Visitors to the ESCRS can learn more about the entire offering of products and solutions from Carl Zeiss Meditec at Booth 215 in Hall Maillot. Congress participants can also register for the ZEISS events during the ESCRS.

Source:

Carl Zeiss Meditec AG