Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), today announced the publication of data from the Company's global clinical trial involving seven sites across five countries. The study, published in the May 2015 edition of the peer-reviewed journal Vision Research, presents the visual results of 29 late-stage RP and cone-rod dystrophy patients implanted with the Alpha IMS subretinal implant.
The study titled, "Subretinal Visual Implant Alpha IMS-Clinical Trial Interim Report," was led by Dr. Katarina Stingl, Centre for Ophthalmology, University of Tuebingen, Schleichstr in coordination with Professor Eberhart Zrenner, M.D., founding director of the Institute of Ophthalmic Research, University of Tuebingen, Germany. Highlights from the study's findings include:
More than 86 percent of patients implanted with the 3x3 mm2 device with 1,500 electrodes experienced improved ability to detect light, including the identification of specific light sources.
Nearly half of the 29 previously blind study patients reported restoration of useful visual experiences in daily life, including the recognition of shapes and household objects, improved ability to identify facial features and some of them even the ability to read letters.
These results led researchers to conclude that the Alpha IMS subretinal implant was successful in restoring partial vision in the majority of blind patients.
"The publication of this data is the culmination of the hard work and dedication of some of the world's leading retinal specialists collaborating to provide life-changing technology to those in need," said Dr. Katarina Stingl, Centre for Ophthalmology, University of Tuebingen, Germany. "The impact of RP is profound for patients, and with no treatment options available until recently, diagnosing patients with the disease has been extremely difficult. For years, the ophthalmology community has strived to develop a treatment or technology that offers a solution to help RP patients regain some useful vision. It is incredibly gratifying to have reached this point."
"Retina Implant's mission is to provide all late-stage RP patients with a safe, effective device to restore some of the vision they have lost," said Walter-G Wrobel, CEO of Retina Implant AG. "Through the establishment of new clinical partners across Europe, securing reimbursement in those countries as well as launching a clinical trial in the U.S., we are executing on our mission to increase access to our technology worldwide."
Results from module one of the trial were gathered at a single center study in Tuebingen, Germany and were the subject of a study in Proceedings of the Royal Society B: Biological Sciences in January 2013. The data from the remaining 20 study participants was collected during a multi-center international trial which took place across Europe and several sites in Asia. Multicenter trial sites include the Centre for Ophthalmology, University of Tuebingen, Germany; Department of Ophthalmology, National University Health System, Singapore; Oxford Eye Hospital and Nuffield Laboratory of Ophthalmology, University of Oxford, Oxford, UK; Klinikum Stuttgart - Katharinenhospital Eye Clinic, Stuttgart, Germany; King's College Hospital and King's College London, Denmark Hill, London; Klinikum Stuttgart – Olgahospital, Stuttgart, Germany; Department of Ophthalmology, Semmelweis University, Budapest, Hungary; STZ Eyetrial, Center for Ophthalmology, University of Tuebingen, Tuebingen, Germany; Klinikum Dresden Friedrichstadt, University Teaching Hospital, Eye Clinic, Dresden, Germany; Li Ka Shing Faculty of Medicine, University of Hong Kong, Hong Kong and Werner Reichardt Centre for Integrative Neuroscience (CIN), Tuebingen, Germany.
About Retina Implant AG
Retina Implant AG is the leading developer of subretinal implants for partially sighted and blind patients. After extensive research with German university hospitals and institutes which began with a large grant from the German Federal Ministry of Research and Education in 1996, Retina Implant AG was founded by Dr. Eberhart Zrenner, professor of Ophthalmology, University of Tuebingen, Germany and his colleagues in 2003 with private investors with the goal of developing a fully-functioning electronic retinal implant to restore useful vision to the blind. Retina Implant began implanting human patients in 2005 and started a second, larger clinical trial in 2010. In July 2013, Retina Implant's wireless subretinal implant technology, Alpha IMS, received CE mark. To learn more about Retina Implant, follow us on Twitter @RetinaImplant.
About Vision Research
Vision Research is devoted to the functional aspects of human, vertebrate and invertebrate vision and publishes experimental and observational studies, reviews, and theoretical papers firmly based upon the current facts of visual science. Vision Research has always welcomed the broadest interpretation of visual science.
Vision Research believes that access to quality research is vital to the scientific community and beyond. The journal supports sustainable access and works hard to provide a range of open access options alongside access initiatives to ensure everyone can read, use and trust the latest research.
Wednesday, May 20, 2015
Experts ponder drug compounding law’s impact on ophthalmology
In 2013, in the wake of infectious outbreaks traced to steroids and repackaged intravitreal Avastin produced at compounding pharmacies, Congress passed the Drug Quality and Security Act, which included the Compounding Quality Act. The law gives the FDA new authorities to regulate the activities of compounding pharmacies, drug repackagers and a new class of “outsourcing manufacturers.”
In subsequent guidance documents, the FDA clarified various requirements regarding the activities of traditional compounders, such as the need to receive a patient-specific prescription for each compounded drug. In a set of draft guidance documents issued in February, the FDA made recommendations on outsourcing facilities, mixing and repackaging, and interstate shipping. Some experts see some of the recommendations as a plus, while others have a less optimistic view.
Overall, the drug compounding law involves a “mixed bag” of upsides and downsides, according to Daniel A. Kracov, JD, OSN Regulatory/Legislative Board Member.
“At a high level, what I think ophthalmologists are going to see is somewhat less availability of certain products that they may have received from compounding facilities previously,” Kracov said. “The purpose of the act, in many respects, is to try to diminish the unlawful practice of compounding of large quantities of, particularly, injectable products in compounding pharmacies and to try to drive those activities into outsourcing facilities, which are subject to good manufacturing practices.”
Judy E. Kim, MD, OSN Retina/Vitreous Board Member, said that while she understands the need for improved oversight of compounding pharmacies for the safety of patients, these laws do not address the unique needs of ophthalmologists, particularly retina specialists, who use Avastin (bevacizumab, Genentech) to treat various ocular conditions, including age-related macular degeneration, diabetic retinopathy, vein occlusions, retinopathy of prematurity and neovascular glaucoma.
“[Some of] these blanket policies are going to negatively impact the physicians and the patients,” Kim said. “In particular, the proposed beyond-use date of 5 days for repackaged biologics, which includes Avastin, is too restrictive and makes it practically impossible to use Avastin for most ophthalmologists. It mandates that we have only 5 days to use the drug from the time it was repackaged at an outsourcing facility, but it does not account for the time to order and ship the drug to our practices and does not account for the days needed for sterility testing of these drugs. Also, this 5-day period seems quite arbitrary, since the literature shows that Avastin remains stable and sterile beyond 5 days. Limiting the access to Avastin means we will be left to use more expensive drugs only, which will not only increase the health care costs, but also result in some patients declining needed treatments because they cannot afford more expensive drugs. FDA should hear different groups’ voices and make logical decisions and consider exceptions as we give them the appropriate biological and safety data. When access to these drugs impacts so many patients, this is a big issue.”
Pharmaceutical consultant Barbara S. Fant, PharmD, voiced support for oversight of compounding pharmacies in light of recent growth and change within the industry.
“I think the extent of compounding pharmacies has definitely increased over the past few years,” Fant said. “There needs to be some sort of oversight, more than there was in the past, because I think the laws and regulations that were passed back then [did not foresee] the extent to which compounding pharmacy facilities would expand into their current role. The regulatory changes need to strike a healthy balance between making compounded drugs available and assuring the safety and quality of the compounded products that are provided.”
In subsequent guidance documents, the FDA clarified various requirements regarding the activities of traditional compounders, such as the need to receive a patient-specific prescription for each compounded drug. In a set of draft guidance documents issued in February, the FDA made recommendations on outsourcing facilities, mixing and repackaging, and interstate shipping. Some experts see some of the recommendations as a plus, while others have a less optimistic view.
Overall, the drug compounding law involves a “mixed bag” of upsides and downsides, according to Daniel A. Kracov, JD, OSN Regulatory/Legislative Board Member.
“At a high level, what I think ophthalmologists are going to see is somewhat less availability of certain products that they may have received from compounding facilities previously,” Kracov said. “The purpose of the act, in many respects, is to try to diminish the unlawful practice of compounding of large quantities of, particularly, injectable products in compounding pharmacies and to try to drive those activities into outsourcing facilities, which are subject to good manufacturing practices.”
Judy E. Kim, MD, OSN Retina/Vitreous Board Member, said that while she understands the need for improved oversight of compounding pharmacies for the safety of patients, these laws do not address the unique needs of ophthalmologists, particularly retina specialists, who use Avastin (bevacizumab, Genentech) to treat various ocular conditions, including age-related macular degeneration, diabetic retinopathy, vein occlusions, retinopathy of prematurity and neovascular glaucoma.
“[Some of] these blanket policies are going to negatively impact the physicians and the patients,” Kim said. “In particular, the proposed beyond-use date of 5 days for repackaged biologics, which includes Avastin, is too restrictive and makes it practically impossible to use Avastin for most ophthalmologists. It mandates that we have only 5 days to use the drug from the time it was repackaged at an outsourcing facility, but it does not account for the time to order and ship the drug to our practices and does not account for the days needed for sterility testing of these drugs. Also, this 5-day period seems quite arbitrary, since the literature shows that Avastin remains stable and sterile beyond 5 days. Limiting the access to Avastin means we will be left to use more expensive drugs only, which will not only increase the health care costs, but also result in some patients declining needed treatments because they cannot afford more expensive drugs. FDA should hear different groups’ voices and make logical decisions and consider exceptions as we give them the appropriate biological and safety data. When access to these drugs impacts so many patients, this is a big issue.”
Pharmaceutical consultant Barbara S. Fant, PharmD, voiced support for oversight of compounding pharmacies in light of recent growth and change within the industry.
“I think the extent of compounding pharmacies has definitely increased over the past few years,” Fant said. “There needs to be some sort of oversight, more than there was in the past, because I think the laws and regulations that were passed back then [did not foresee] the extent to which compounding pharmacy facilities would expand into their current role. The regulatory changes need to strike a healthy balance between making compounded drugs available and assuring the safety and quality of the compounded products that are provided.”
Monday, May 18, 2015
American Academy of Ophthalmology Committed to Supporting Eye Care in Nepal After Earthquake
In response to the devastating earthquake that struck Nepal on April 25, the American Academy of Ophthalmology has established the Nepal Eye Care Relief Fund. This fund will support rebuilding efforts to deliver much-needed eye care to the people of Nepal.
Prior to the earthquake, which has taken thousands of lives and affected millions more, there was a critical need for eye care in Nepal. Approximately 93,400 people in this mountainous Himalayan country are blind and more than 280,000 have low vision, largely due to preventable or treatable causes. With more than 30 million people but fewer than 200 ophthalmologists, many struggle to get the eye care they need. In the aftermath of the earthquake, patients may find it even more difficult to get treatment that could help save their vision.
To assist with recovery efforts, the Academy will continue working with its long-standing partners at the Nepal Ophthalmic Society and Nepal Netra Jyoti Sangh, an in-country non-governmental organization for eye care, to provide support. The Academy has worked with both groups for many years to provide vital clinical education resources to Nepalese ophthalmologists to improve patient care. In addition, the Academy has created a task force that is currently identifying additional respected non-governmental organizations that are working effectively during this crisis in Nepal, especially those involved in re-establishing eye care services.
"As a result of the disaster, many ophthalmologists in Nepal are now unable to provide quality eye care to those who need it most," said David W. Parke II, M.D., CEO of the Academy. "By working closely with our colleagues in Nepal, we will support the re-establishment of critical eye care services and education through this challenging time. We know that helping our Nepalese colleagues rebuild their eye care practices will have a ripple effect across the rest of this devastated population."
In 2010, Academy members responded with an abundance of generosity in the aftermath of the Haiti earthquake. All of the funds collected through the Nepal Eye Care Relief Fund will be used to rebuild capacity to deliver eye care in Nepal. Those interested in donating can learn more at https://secure.aao.org/apps/Default.aspx?tabid=484. Donations are tax deductible.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology, headquartered in San Francisco, is the world's largest association of eye physicians and surgeons, serving more than 32,000 members worldwide. The Academy's mission is to advance the lifelong learning and professional interests of ophthalmologists to ensure that the public can obtain the best possible eye care. For more information, visit www.aao.org.
The Academy is also a leading provider of eye care information to the public. The Academy's EyeSmart® program educates the public about the importance of eye health and empowers them to preserve healthy vision. EyeSmart provides the most trusted and medically accurate information about eye diseases, conditions and injuries. OjosSanos™ is the Spanish-language version of the program. Visit www.geteyesmart.org or www.ojossanos.org to learn more.
Prior to the earthquake, which has taken thousands of lives and affected millions more, there was a critical need for eye care in Nepal. Approximately 93,400 people in this mountainous Himalayan country are blind and more than 280,000 have low vision, largely due to preventable or treatable causes. With more than 30 million people but fewer than 200 ophthalmologists, many struggle to get the eye care they need. In the aftermath of the earthquake, patients may find it even more difficult to get treatment that could help save their vision.
To assist with recovery efforts, the Academy will continue working with its long-standing partners at the Nepal Ophthalmic Society and Nepal Netra Jyoti Sangh, an in-country non-governmental organization for eye care, to provide support. The Academy has worked with both groups for many years to provide vital clinical education resources to Nepalese ophthalmologists to improve patient care. In addition, the Academy has created a task force that is currently identifying additional respected non-governmental organizations that are working effectively during this crisis in Nepal, especially those involved in re-establishing eye care services.
"As a result of the disaster, many ophthalmologists in Nepal are now unable to provide quality eye care to those who need it most," said David W. Parke II, M.D., CEO of the Academy. "By working closely with our colleagues in Nepal, we will support the re-establishment of critical eye care services and education through this challenging time. We know that helping our Nepalese colleagues rebuild their eye care practices will have a ripple effect across the rest of this devastated population."
In 2010, Academy members responded with an abundance of generosity in the aftermath of the Haiti earthquake. All of the funds collected through the Nepal Eye Care Relief Fund will be used to rebuild capacity to deliver eye care in Nepal. Those interested in donating can learn more at https://secure.aao.org/apps/Default.aspx?tabid=484. Donations are tax deductible.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology, headquartered in San Francisco, is the world's largest association of eye physicians and surgeons, serving more than 32,000 members worldwide. The Academy's mission is to advance the lifelong learning and professional interests of ophthalmologists to ensure that the public can obtain the best possible eye care. For more information, visit www.aao.org.
The Academy is also a leading provider of eye care information to the public. The Academy's EyeSmart® program educates the public about the importance of eye health and empowers them to preserve healthy vision. EyeSmart provides the most trusted and medically accurate information about eye diseases, conditions and injuries. OjosSanos™ is the Spanish-language version of the program. Visit www.geteyesmart.org or www.ojossanos.org to learn more.
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