Contact Lenses A Good Choice For Children 12 And Younger

Children 8 to 12 years old are just as adept as teenagers at handling and wearing contact lenses.

“Optometrists traditionally don’t prescribe contact lenses to children until they are at least 12 years old,” said Jeffrey Walline, an assistant professor of optometry at Ohio State University. “But we found that younger children are just as responsible with their lenses.”

He and his colleagues studied 169 children and teenagers who participated in the Contact Lens in Pediatrics (CLIP) study, which compares contact lens wear in children 8 to 12 with teens 13 to 17. About half the participants were in each group.

The researchers presented their findings from the month-long study on December 8 in Denver at the annual meeting of the American Academy of Optometry. The current findings confirm those of a much smaller study conducted by Walline and others, which suggested that children 8 to 12 could easily handle daily disposable contact lenses.

None of the children or teens in the current study had worn contact lenses prior to the study. The researchers gave each participant a three-month supply of disposable soft contact lenses, instructing the children and teens to take the lenses out each night and to throw each pair away after two weeks.

Each participant answered questions on the Pediatric Refractive Error Profile (PREP), a survey containing quality-of-life questions related to wearing contact lenses and glasses. The children and teens filled out the profile before they began to wear contact lenses, and again one month after wearing the lenses. PREP scores range from 100 (excellent quality of life) to 0 (poor quality of life.)

Questions included how much a child or teen liked wearing contact lenses or glasses, how clear her vision was while wearing the lenses or glasses, what her eyes physically felt like when wearing lenses or glasses, friends’ reactions to the change and how easy the contact lenses were to handle.

PREP scores suggested that the children and teens were more satisfied with wearing contact lenses than with wearing glasses: scores rose from 65 (pre-contact lens wear) to 74.5 for children, and from 63 (pre-contact lens wear) to 73 for teens.

“The biggest boosts were in terms of satisfaction with their correction and also with participation in activities,” Walline said. “Children and teens reported that it was much easier to engage in sports, dancing and other activities while wearing contact lenses.”

The researchers noted that there was little change in participants’ feelings toward their own appearance, nor did peer perceptions seem to change dramatically once a child or teen began wearing contact lenses.

“Vanity doesn’t seem to be a factor in children’s or teens’ satisfaction with switching to contact lenses,” Walline said.

Children wore their lenses almost as long as teens – parents reported that their children wore the contact lenses about 10.5 hours a day, while teens wore their lenses about 11.5 hours each day.

The soft disposable contact lenses used in this study, along with the necessary cleaning solutions, can cost roughly $260 a year, said Walline. Since children’s and teens’ vision can change very fast, such lenses are typically sold in a six-month supply. Adults can buy a one-year supply.

Walline and his colleagues are currently analyzing data gathered from the study participants after three months of wearing the contact lenses. Although that data isn’t included in this presentation, Walline said the findings are very similar to what he and his colleagues found at the one-month point.

“Children are very capable of taking care of contact lenses on their own,” he said.

In related work, Walline and his colleagues found that optometrists initially spend about 14 minutes longer fitting a child with contact lenses and teaching him how to insert and remove those lenses (total exam time was 110 minutes for children and 96 minutes for teens.)

“After the training is complete, children and teens both showed excellent understanding of contact lens care,” Walline said.

He conducted the study with Ohio State colleagues Lisa Jones, David Berntsen, Stacy Long and Monica Chitkara and with colleagues from the University of Houston and the New England College of Optometry.

Holly Wagner

Contact: Jeffrey Walline

Ohio State University

Cancer Drug Is No Different In Effectiveness As Gold Standard Treatment For Macular Degeneration

Investigators from Boston University School of Medicine (BUSM) and the VA Boston Healthcare System have shown, at 6 months in a small group of patients, that there is no difference in efficacy between Bevacizumab (Avastin) and Ranibizumab (Lucentis) for the treatment of age-related macular degeneration (AMD). The study, which appears currently on-line in the American Journal of Ophthalmology, is the first to report early outcomes of a prospective, double-masked, randomized, controlled trial comparing Bevacizumab to Ranibizumab for the treatment of exudative (wet) age-related macular degeneration.

AMD is the leading cause of blindness over the age of 50 in developed Western countries. It can present in 2 forms, exudative (wet) or nonexudative (dry). While dry AMD can lead to severe vision loss, wet AMD is often more visually devastating with a higher risk of blindness. The gold standard of treatment is ranibizumab (Lucentis, Genentech Inc.), which was FDA approved for AMD in 2006. Bevacizumab (Avastin, Genentech Inc.) was FDA approved for colo-rectal cancer in 2004, and has since been used worldwide as an off-label, local intravitreal treatment for wet AMD. Both have shown to be efficacious in the treatment of AMD, however, it is unknown which one is more effective.

This study was supported with resources and the use of facilities at the Veterans Affairs Boston Healthcare System, Jamaica Plain, MA. The VA funded the cost of medications for this study. Patients were enrolled by a 2:1 randomization to either the bevacizumab (2) or ranibizumab (1) arm of the study. Once inclusion criteria were met, patients were given intravitreal injection of bevacizumab or ranibizumab every month for the first three months (as they began the trial, month one, and month two). Following the third injection, patients returned for monthly examination and testing and received further injections on an as needed basis for one year.

“Our study aimed to offer early, six-month results of a randomized, double-masked, single center clinical trial comparing the off-label use of bevacizumab with the current gold standard ranibizumab. With a total of 20 subjects and a 2:1 randomization, early results of this trial suggest that at 6 months, visual outcomes of bevacizumab appear to be no different from ranibizumab,” said lead author and Principal Investigator Manju Subramanian, MD, an assistant professor in Ophthalmology at BUSM.

Genentech Pharmaceuticals (the manufacturer of both drugs) has refused to sponsor a head to head trial comparing the 2 treatments. The open market cost of a single injection of Ranibizumab (Lucentis) is approximately $2000.00. Comparatively, the cost of a single injection of Bevacizumab (Avastin) for AMD is $40.00. Patients potentially undergo up to 13 injections per year, leading to a large cost differentiation for treatment of this common eye disease. The National Eye Institute is sponsoring the Comparison of AMD Treatment Trials Study (CATT Study), a multi-centered, randomized, double-masked, clinical trial designed to assess the efficacy of bevacizumab compared to ranibizumab therapy and will be conducted in 44 clinical centers throughout the United States. Early results are expected in 2011.

Source:
Gina DiGravio

Boston University Medical Center

View drug information on Avastin; Lucentis.

A Mobile, Four-Wheeled Platform, CYCLOPS May Help Refine And Enhance The Design Of Visual Prostheses

Scientists at the California Institute of Technology (Caltech) have created a remote-controlled robot that is able to simulate the “visual” experience of a blind person who has been implanted with a visual prosthesis, such as an artificial retina. An artificial retina consists of a silicon chip studded with a varying number of electrodes that directly stimulate retinal nerve cells. It is hoped that this approach may one day give blind persons the freedom of independent mobility.

The robot – or, rather, the mobile robotic platform, or rover – is called CYCLOPS. It is the first such device to emulate what the blind can see with an implant, says Wolfgang Fink, a visiting associate in physics at Caltech and the Edward and Maria Keonjian Distinguished Professor in Microelectronics at the University of Arizona. Its development and potential uses are described in a paper recently published online in the journal Computer Methods and Programs in Biomedicine.

An artificial retina, also known as a retinal prosthesis, may use either an internal or external miniature camera to capture images. The captured images then are processed and passed along to the implanted silicon chip’s electrode array. (Ongoing work at Caltech’s Visual and Autonomous Exploration Systems Research Laboratory by Fink and Caltech visiting scientist Mark Tarbell has focused on the creation and refinement of these image-processing algorithms.) The chip directly stimulates the eye’s functional retinal ganglion cells, which carry the image information to the vision centers in the brain.

CYCLOPS fills a void in the process of testing visual prostheses, explains Fink. “How do you approximate what the blind can see with the implant so you can figure out how to make it better?” he asks.

One way is to test potential enhancements on a blind person who has been given an artificial retina. And, indeed, the retinal implant research team does this often, and extensively. But few people worldwide have been implanted with retinal prostheses, and there is only so much testing they can be asked to endure.

Another way is to give sighted people devices that downgrade their vision to what might be expected using artificial vision prostheses. And this, too, is often done. But it’s a less-than-ideal solution since the brain of a sighted person is adept at taking poor-quality images and processing them in various ways, adding detail as needed. This processing is what allows most people to see in dim light, for example, or through smoke or fog.

“A sighted person’s objectivity is impaired,” Fink says. “They may not be able to get to the level of what a blind person truly experiences.”

Enter one more possible solution: CYCLOPS. “We can use CYCLOPS in lieu of a blind person,” Fink explains. “We can equip it with a camera just like what a blind person would have with a retinal prosthesis, and that puts us in the unique position of being able to dictate what the robot receives as visual input.”

Now, if scientists want to see how much better the resolution is when a retinal prosthesis has an array of 50 pixels as opposed to 16 pixels, they can try both out on CYCLOPS. They might do this by asking the robot to follow a black line down a white-tiled hallway, or seeing if it can find – and enter – a darkened doorway.

“We’re not quite at that stage yet,” Fink cautions, referring to such independent maneuvering.

CYCLOPS’s camera is gimballed, which means it can emulate left-to-right and up-and-down head movements. The input from the camera runs through the onboard computing platform, which does real-time image processing. For now, however, the platform itself is moved around remotely, via a joystick. “The platform can be operated from anywhere in the world, through its wireless Internet connection,” says Tarbell.

“We have the image-processing algorithms running locally on the robot’s platform – but we have to get it to the point where it has complete control of its own responses,” Fink says.

Once that’s done, he adds, “we can run many, many tests without bothering the blind prosthesis carriers.”

Among the things they hope to learn from such testing is how to enhance a workplace or living environment to make it more accessible to a blind person with a particular vision implant. If CYCLOPS can use computer-enhanced images from a 50-pixel array to make its way safely through a room with a chair in one corner, a sofa along the wall, and a coffee table in the middle, then there is a good chance that a blind person with a 50-pixel retinal prosthesis would be able to do the same.

The results of tests on the CYCLOPS robot should also help researchers determine whether a particular version of a prosthesis, say, or its onboard image-processing software, are even worth testing in blind persons. “We’ll be coming in with a much more educated initial starting point, after which we’ll be able to see how blind people work with these implants,” Fink notes.

And the implants need to work well. After all, Fink points out, “Blind people using a cane or a canine unit can move around impressively well. For an implant to be useful, it has to have the implicit promise that it will surpass these tools. The ultimate promise – the hope – is that we instill in them such useful vision that they can attain independent mobility, can recognize people, and can go about their daily lives.”

The work done in the paper by Fink and Tarbell, “CYCLOPS: A mobile robotic platform for testing and validating image processing and autonomous navigation algorithms in support of artificial vision prostheses,” was supported by a grant from the National Science Foundation. Fink and Tarbell have filed a provisional patent on the technology on behalf of Caltech.

Source:
Lori Oliwenstein

California Institute of Technology

New Data On Lucentis (ranibizumab) – Continued Treatment Achieves Sustained Benefits In Visual Acuity And Quality Of Life In Patients With AMD

New data with Lucentis (ranibizumab) show that continued treatment achieves sustained benefits in visual acuity and quality of life in patients with wet age-related macular degeneration (AMD) out to two years, according to latest results from a study reported during the recent European Society of Ophthalmology annual meeting (9-12 June 2007; Vienna, Austria).

The ANCHOR (Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration) study randomised patients with predominantly classic neovascular age-related macular degeneration in a 1:1:1 ratio to monthly intravitreal injections of ranibizumab (0.3 mg or 0.5 mg) plus sham verteporfin therapy or monthly sham injections plus active verteporfin therapy (photodynamic therapy, PDT; the current standard of care).

Results showed that 89.9% of patient randomised to Lucentis lost fewer than 15 letters on a visual acuity chart at 24 months compared to 65.7% of those treated with PDT (p

Lions Support 4.3 Million Cataract Surgeries In China

Lions Clubs International has supported 4.3 million cataract surgeries
in China since 1997 when it partnered with the Chinese government to
improve eye health.

Lions also worked with Chinese health officials on its SightFirst China
Action project to establish surgical eye units in 104 rural counties
that previously had none. Current initiatives include creating secondary
eye care units at hospitals in 200 less developed counties, cities and
provinces and establishing eye health training courses for paramedics
who work among the poor in western and northern provinces.

The World Health Organization estimates that twenty percent of those
blind in the world live in China.

“The commitment by the Chinese government and the China Disabled
Persons’ Federation to SightFirst China Action is a key to this
successful partnership. Working together, we have increased the number
of persons in China receiving surgeries annually from 200,000 in 1996 to
over 600,000. This is one of our largest and most successful SightFirst
programs,” said Dr. Clement F. Kusiak, chairperson of Lions Clubs
International Foundation (LCIF), the grant-making arm of Lions Clubs
International.

LCIF’s SightFirst program is a worldwide blindness prevention
initiative that has prevented vision loss for hundreds of millions.
SightFirst, LCIF’s largest program, combats blindness by building
hospitals and clinics, training doctors, nurses and other healthcare
workers, distributing medicine and raising awareness of eye disease.
SightFirst fights the major causes of blindness: cataract, river
blindness, trachoma, and, especially in developed nations like the
United States, diabetic eye disease and glaucoma. SightFirst also
supports the Lions/WHO Global Project for the Elimination of Avoidable
Blindness in Children, the first worldwide initiative addressing
childhood blindness.

A team of WHO experts and representatives from LCIF, the Ministry of
Health and the China Disabled Persons’ Federation undertook an
evaluation of SightFirst China Action in March. The evaluators split
into teams, completing work in the three provinces of Guizhou, Henan,
and Liaoning. The findings of the evaluation indicated that the
project’s targets are being surpassed.

Phase I of SightFirst China Action supported 2.1 million cataract
surgeries. The goal for Phase II is another 2.5 million surgeries.

“SightFirst China Action Phase II has completed 88% of the 2.5
million cataract surgeries planned for 2002 – 2007 in a three-year
period,” said Dr. Wing-Kun Tam, Executive Chair of SFCA. “With
this level of enthusiasm and support, we know the goal will be
surpassed. Even more important, training of almost 20,000 eye care
personnel helps to guarantee the long-term impact of SFCA in blindness
prevention in China.”

Based in Oak Brook, Illinois, Lions Clubs International is the
world’s largest service club organization with over 1.35 million
members in approximately 46,000 clubs in 197 countries and geographical
areas around the world. Since 1917, Lions clubs have aided the blind and
visually impaired and made a strong commitment to community service and
serving youth throughout the world. For more information about Lions
Clubs International, visit the Web site at lionsclubs.

Lions Clubs International Foundation(LCIF)
300 W. 22nd St.
Oak Brook, IL 60523-8842
USA
lcif

Digital Technology Improves Eye Exams For American Indian Tribe

New digital photography technology has made screening for diabetes-related vision diseases more convenient and cost effective for members of the Fort Mojave American Indian tribe in Arizona, the Arizona Republic reports. Tribe spokesperson Kelly Hills said American Indians have the highest diabetes rate in the nation at more than twice that of the general population. Those with diabetic retinopathy usually do not have visible symptoms of the disease until their condition has progressed beyond repair.

According to the Republic, some tribal members have traveled to other cities to be screened for eye diseases, but two weeks ago, the Fort Mojave American Indian Health Center began offering the new imaging technology by the Joslin Vision Network. The technology takes quick digital snapshots of a patient’s eye and transmits the images to Phoenix to be analyzed for signs of bleeding, according to the Republic. The test is particularly effective for patients who do not like to have their pupils dilated, Janelle Froelich, an optometrist at the health center, said.

The technology is a part of number of improvements at the center in the past 10 years, according to the Republic. Vickie Seccombe, the health center’s director, said, “Ten years ago, there was very little direct care to the patients in this community,” adding, “I think the Fort Mojave Indian Tribe determined that it was time their community members and their tribal members had health care in their community” (Popovici, Arizona Republic, 10/12).

Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.

© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

New lasik research reveals unexpected finding: Key to better-than-20/20 vision is in the flap

Surgeon’s choice of laser or blade for corneal flap plays role in visual outcome of procedure –

New scientific data being presented at this year’s ASCRS meeting reveals the key to a better-than-20/20 outcome in LASIK
surgery may depend on whether your doctor uses a blade or a laser to create the corneal flap in the first step of the
procedure.

“It turns out that the flap that we make in LASIK is not an innocent bystander,” says Roger F. Steinert, M.D., 2005 ASCRS
president, professor of ophthalmology, professor of biomedical engineering, director of cornea, refractive and cataract
surgery, and vice chair of clinical ophthalmology at University of California, Irvine.

“We now have data validating something we suspected for the past year but hadn’t firmly proven, which is that the rate of
achieving high levels of vision is better with the IntraLase laser than with the conventional metal microkeratome. On
theoretical grounds we knew flap creation with IntraLase would be safer, and its performance bore that out. But we didn’t
anticipate seeing a difference in actual vision. Multiple studies now show higher rates of 20/20, higher rates of better than
20/20, and that Custom treatments show better results as well.”

RESEARCH SUMMATION

LASIK has always been a two-step process. In the first step, the surgeon makes a thin flap and folds it back for the second
step, where an excimer laser is used to ablate corneal tissue for vision correction.

— Until now, advancements like Custom LASIK and Wavefront have focused on improving the second step (precision of tissue
ablation). But new research shows the importance of the first step on visual outcomes. The discovery was made when surgeons
began using a new laser, instead of the hand-held microkeratome blade, to create the corneal flap.

— Doctors found that in addition to fewer complications, more patients achieved vision better than 20/20 — up to 20/15 and
even 20/12.5 — when the IntraLase laser was used in the first step.

— When the microkeratome was used to make the corneal flap, surgeons found a greater incidence of high and low spots and
irregular hydration on the corneal surface, factors that can compromise the tissue ablation, and with it the visual outcome.

— Multiple clinical studies show the IntraLase laser provides for better vision by creating an optimal corneal surface under
the flap, allowing for more precise vision correction.

Contact: Kimberly Goolsby
kimberlygoolsbygroup
949-464-0187
Goolsby Group
goolsbygroup

Cosmetic Contacts Can Be A ‘Scary’ Choice For Halloween

Halloween means big business for a variety of stores-adults and children alike search for the perfect costume and accessories to transform themselves into a character or superhero for a day. However, the American Optometric Association (AOA) is warning consumers about the risks of wearing decorative contact lenses without a prescription from an eye doctor. These non-corrective lenses, which are designed only to change the appearance of the eyes, are easily accessible to consumers and are especially popular around Halloween.

Federal law requires the Food and Drug Administration (FDA) to regulate decorative lenses as medical devices, similar to corrective lenses. However, decorative lenses continue to be illegally marketed and distributed directly to consumers through a variety of sources, including flea markets, the Internet, beauty salons and convenience stores. Consumers can also find them at retail outlets where they are sold as fashion accessories.

According to the AOA, only a medical eye and vision evaluation from an eye doctor can determine whether or not patients are viable candidates to wear contact lenses, if they are capable of wearing lenses without problems, and that the lenses fit properly.

“Decorative contacts are a concern all year long, but Halloween is a time when people use them most to enhance costumes,” said Dr. Barry Eiden, chair of the AOA’s Contact Lens and Cornea Section. “Consumers who purchase lenses without a prescription or without consultation from an eye doctor put themselves at risk of serious bacterial infection, or even significant damage to the eye’s ability to function, with the potential for irreversible sight loss.”

Risks associated with the improper use of decorative contact lenses include conjunctivitis, swelling, allergic reaction and corneal abrasion due to poor lens fit. Additional medical problems may result in a reduction of visual acuity (sight), contrast sensitivity and other general eye and vision impairments.

“Even though they carry no prescription, and may be worn for short periods of time, decorative contact lenses carry the same risks as corrective contact lenses,” said Dr. Eiden. “Because of this, it’s important for consumers utilizing these lenses to familiarize themselves with the information available from an eye doctor, so as to reduce the risk of infection.”

Recommendations for Decorative Contact Lens Wearers from the American Optometric Association

1. See an optometrist for your regularly scheduled contact lens and eye examination and for a proper fitting and prescription.

2. Always wash your hands before handling contact lenses.

3. Carefully and regularly clean contact lenses, as directed by your optometrist. Rub the contact lenses with fingers and rinse thoroughly before soaking lenses overnight in sufficient multi-purpose solution to completely cover the lens.

4. Store lenses in the proper lens storage case and replace the case every three months or sooner. Clean the case after each use, and keep it open and dry between cleanings.

5. Use only products recommended by your optometrist to clean and disinfect your lenses. Saline solution and rewetting drops are not designed to disinfect lenses.

6. Only fresh solution should be used to clean and store contact lenses. Never re-use old solution. Contact lens solution must be changed according to the manufacturer’s recommendations, even if the lenses are not used daily.

7. Always follow the recommended contact lens replacement schedule prescribed by your optometrist.

8. Remove contact lenses before swimming or entering a hot tub.

For more information about the risks of decorative contact lenses, or to find additional resources pertaining to contact lens hygiene and compliance, please visit aoa.

Source
American Optometric Association (AOA)

Researchers Make First Bioartificial Organ In Spain

A University of Granada research group composed of professors Antonio Campos and Miguel Alaminos (histologists), Maria del Mar Perez, Ana Ionescu and Juan de la Cruz Cardona (opticians) and the ophthalmologist Miguel Gonzalez Andrades, University Hospital San Cecilio, Granada, have made the first bioartificial organ in Spain

Researchers extracted pig corneal cells and replaced them with human stem cells. This method, known as decellularization and recellulation, allows scientists to maintain the basic structure of the cornea and replace its cellular components.

The results obtained in this study were described in an article published in the most prestigious online research journal on ophthalmology: IOVS (Investigative Ophthalmology and Visual Science).

An artificial cornea

These University of Granada researchers belong to the same research group that made an artificial cornea with biomaterials designed at the Tissue Engineering Laboratory of the University of Granada, that is currently on the preparatory stage to start a clinical trial.

At present, the authors of this study are promoting the establishment of an Institute for Tissue Engineering in Granada, which is currently on the feasibility and design phase.

This release is available in French and Spanish.

Source:
Antonio Campos Mu?┬▒oz
University of Granada

Microplasmin Meets Primary Endpoint In Second Phase III Trial In VMA, Confirms Positive Findings Of First Trial

ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the discovery and development of innovative treatments for eye disease, vascular disease and cancer announces that its second Phase III trial evaluating microplasmin for the non-surgical treatment of vitreomacular adhesion (VMA) has met its primary endpoint. Importantly, the trial also confirmed the positive results seen in the first Phase III trial with microplasmin. The results of the second Phase III trial (TG-MV-007) were presented for the first time at the American Society of Retina Specialists (ASRS) Annual Meeting by Dr. J. Michael Jumper (West Coast Retina and Medical Group and California Pacific Medical Center, California, USA). The trial recruited 326 patients at 48 centers in Europe and the U.S.

The detailed positive results from the first Phase III trial in the microplasmin MIVI-TRUST program (TG-MV-006) were presented at the World Ophthalmology Congress in Berlin in June 2010. The pooled results of both trials will be presented at the upcoming EURETINA (European Society of Retina Specialists) Congress in Paris, France, on September 4 by Prof. Peter Stalmans (University Hospitals Leuven, Belgium).

In his presentation at ASRS, Dr. Jumper highlighted that the TG-MV-007 study had met its primary endpoint, with 25.3% of the 245 microplasmin treated patients achieving resolution of their VMA at 28 days, compared to 6.2% of the 81 patients who received a placebo injection, a highly statistically significant result (p=0.001). In patients without epiretinal membrane, microplasmin was shown to be even more effective with 34.5% of patients seeing resolution of their VMA at 28 days, compared to 6.4% of placebo treated patients. Epiretinal membrane is a layer of scar tissue which builds up on the macula, making it more difficult to achieve resolution of VMA without surgical intervention. Epiretinal membrane can be easily identified using Optical Coherence Tomography (OCT).

The TG-MV-007 trial also showed that microplasmin was highly effective in treating patients who had been diagnosed with full thickness macular hole (FTMH). In this group, 36.7% of the 49 patients saw closure of their FTMH at 28 days following a single 125g micro injection of microplasmin, without the need for a vitrectomy. This compares with 6.7% of the 15 patients in the placebo group (p= 0.028). These positive results are in line with what was achieved in this patient group in the TG-MV-006 study.

The TG-MV-007 study also evaluated the visual acuity (VA) of patients. This analysis showed that at the end of the study 22.0% of the microplasmin treated patients had achieved at least a 10 letter (2 lines) improvement in VA without the need for vitrectomy. This compares to only 11.1% of the patients who received a placebo injection (p

The TG-MV-007 study confirmed that microplasmin was generally safe and well tolerated. Importantly, consistent with the findings of the TG-MV-006, there was no evidence of an increased risk of retinal tear or detachment.

Dr. Patrik De Haes, CEO of ThromboGenics, commented, “I am very pleased that the results from the TG-MV-007 study announced yesterday have confirmed the positive findings of the first Phase III trial and clearly show microplasmin’s potential to make a significant impact on the treatment of vitreoretinal disorders. Over the next several months, key investigators who participated in the studies will be presenting the exciting data from the overall MIVI-TRUST program to the global retina community at a number of major international ophthalmology congresses. Given the success of the overall Phase III clinical program, I am extremely confident that microplasmin has the potential to provide both patients and retina specialists with a highly attractive treatment option for a broad range of retinal disorders.”

Dr. J. Michael Jumper, commenting on his presentation at the ASRS, said, “These results confirm microplasmin’s potential to treat patients with macular disease caused by vitreous traction, including full thickness macular hole (a condition which currently requires major eye surgery to prevent irreversible vision loss), with a single intravitreal injection, a very appealing option when compared to surgery.”

16th Annual Gertrude D. Pyron Award for Outstanding Achievement in Retina Research

Dr. Julia Haller (Ophthalmologist-in-Chief, Wills Eye Institute, and Professor and Chair of Department of Ophthalmology of Thomas Jefferson University, Philadelphia), was presented with the 16th Annual Gertrude D. Pyron Award for Outstanding Achievement in Retina Research at ASRS. At the meeting, she chose to discuss microplasmin as a treatment option for retinal diseases in the Pyron Lecture entitled, “Ties That Bind: The Vitreo-Retinal Relationship.” The lecture, which took place on August 29, centered on the positive results of the microplasmin Phase III program, with particular focus on the wealth of new information about the vitreoretinal interface that the MIVI-TRUST program has generated and its implications for the vitreoretinal surgeon.

About Focal Vitreomacular Adhesion (VMA)

Focal vitreomacular adhesion is a condition in which the vitreous gel, in the center of the eye, has an abnormally strong adhesion to the macula, the center of the retina at the back of the eye. Vitreomacular adhesion plays a key role in numerous back of the eye conditions, such as macular hole and some forms of macular edema. Vitreomacular adhesion is also associated with a worse prognosis in certain major eye conditions, including Diabetic Retinopathy and Age-related Macular Degeneration (AMD).

About Macular Hole

Focal vitreomacular adhesion can lead to macular hole, where the traction from the vitreomacular adhesion actually pulls off a piece of the macula (the part of the retina responsible for central vision). If not treated with major eye surgery called a vitrectomy, which involves using suction to remove the vitreous from the eye, macular hole can lead to irreversible, central blindness. While vitrectomy is generally effective in closing macular holes, it is an invasive procedure and a proportion of patients experience side-effects. These include alteration of vision, bleeding, retinal detachment and development of glaucoma and cataracts. Therefore, a nonsurgical treatment option for such patients could be an important breakthrough in the way macular hole patients are treated.

The MIVI-TRUST Program

The microplasmin Phase III program, referred to as MIVI-TRUST (Microplasmin for IntraVitreous Injection-Traction Release without Surgical Treatment), consists of two multi-center, randomized, placebo controlled, double-masked trials. These trials are designed to evaluate a single dose of 125g micro microplasmin versus placebo in the intravitreal treatment of patients with symptomatic focal vitreomacular adhesion (VMA). The primary endpoint of both trials is the non-surgical resolution of focal vitreomacular adhesion one month after a single injection of microplasmin. This endpoint is assessed using optical coherence tomography (OCT). The MIVI-TRUST program is the largest interventional clinical program ever performed to specifically evaluate the vitreoretinal interface in patients with retinal disorders. In total, over 650 patients were enrolled in these trials, which were held across 90 centers in 7 countries.

Important information about forward-looking statements

Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the Company’s Annual Report.

Source: ThromboGenics NV