Sirion gets FDA Fast Track designation for sight-preserving drug
Tampa Bay Business Journal
Sirion Therapeutics Inc. announced positive results from a clinical trial evaluating a treatment for certain persons with macular degeneration.
The Phase II trial evaluated fenretinide as a treatment for geographic atrophy associated with age-related macular degeneration.
Sirion describes fenretinide as an oral vitamin A binding protein antagonist. Geographic atrophy is the most advanced form of dry age-related macular degeneration.
An analysis of the Phase II data showed slower growth of lesions in patients treated with oral fenretinide than in patients who received a placebo, a release from Sirion said.
Sirion will continue the Phase II study and will meet with scientific advisers and the Food and Drug Administration to design a Phase III study, the release said.
The effort by Sirion to develop fenretinide as a treatment got an additional boost when the FDA granted it Fast Track designation, the release said. Fast Track programs of the FDA are designated to facilitate the development of drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address an unmet medical need for such a condition.
Sirion is a privately held biopharmaceutical company based in Tampa focused on discovery, development and commercialization of products to protect and preserve eyesight.
Sunday, April 26, 2009
Sunday, April 19, 2009
New Drug May Help Treat, Reverse Advanced Macular Degeneration
Apr 13, 2009
Reporter: CBS News
Email Address: news@kbtx.com
As the baby boomers age and live longer, a severe sight problem called Macular Degeneration is becoming more common.
But, there are new treatments to help the condition that can lead to blindness.
Sylvia Moore was diagnosed with macular degeneration three years ago.
"If I look straight ahead at somebody's face, I don't see them at all, you'd see a blank spot, a black spot," says Moore of the disease.
Macular Degeneration is most common in seniors.
It happens when blood vessels in the back of the eye start leaking and is the leading cause of blindness in people over 65.
The good news is doctors now have more weapons than ever to fight the condition, and in some cases even reverse it.
When it's caught early, vitamin therapy can slow down the progression of macular degeneration, and in some cases laser surgery can halt vision loss.
But the latest treatment is a drug that's injected directly into the eye.
The medication targets the abnormal blood vessels leading to its shutdown and hopefully to the improvement in vision.
Moore has been getting the injections for three months and is already seeing a difference.
"Its scary when you see a needle coming at you but it doesn't hurt.... I'd rather have that than blindness," Moore says.
A new study predicts some 9 million americans will be diagnosed with macular degeneration next year.
That number is expected to double in the next 40 years.
Apr 13, 2009
Reporter: CBS News
Email Address: news@kbtx.com
As the baby boomers age and live longer, a severe sight problem called Macular Degeneration is becoming more common.
But, there are new treatments to help the condition that can lead to blindness.
Sylvia Moore was diagnosed with macular degeneration three years ago.
"If I look straight ahead at somebody's face, I don't see them at all, you'd see a blank spot, a black spot," says Moore of the disease.
Macular Degeneration is most common in seniors.
It happens when blood vessels in the back of the eye start leaking and is the leading cause of blindness in people over 65.
The good news is doctors now have more weapons than ever to fight the condition, and in some cases even reverse it.
When it's caught early, vitamin therapy can slow down the progression of macular degeneration, and in some cases laser surgery can halt vision loss.
But the latest treatment is a drug that's injected directly into the eye.
The medication targets the abnormal blood vessels leading to its shutdown and hopefully to the improvement in vision.
Moore has been getting the injections for three months and is already seeing a difference.
"Its scary when you see a needle coming at you but it doesn't hurt.... I'd rather have that than blindness," Moore says.
A new study predicts some 9 million americans will be diagnosed with macular degeneration next year.
That number is expected to double in the next 40 years.
Saturday, April 11, 2009
Eye 'compensates for blind spot'
Eye 'compensates for blind spot'
Eye Peripheral vision is retained
Partially sighted and registered blind people can be taught to read and see faces again using the undamaged parts of their eyes, say experts.
When only the central vision is lost, as with the leading cause of blindness, age-related macular degeneration, peripheral vision remains intact.
And patients can be taught to exploit this, the Macular Disease Society says.
It has developed a training scheme and is calling for professionals to adopt the system across the UK.
The macula is a small area of the retina at the back of the eye made up of specialist cells which process central vision as well as the fine detail of what we see.
Our scheme has transformed lives - helping people to relearn basic skills they thought to have lost for good
Tom Bremridge
Macular Disease Society
People with macular degeneration rarely go totally blind but even those with a relatively mild version of the disease cannot drive and have difficulty reading, recognising faces and watching television.
But studies show people can be taught to use their peripheral vision to fill in the gaps, using "eccentric viewing" and "steady eye techniques".
When someone with central vision loss looks directly at an object it may disappear, go faint, blur or distort. But when they look above, below or to one side of it, they see it more clearly.
Blind spots
Eccentric viewing helps people find exactly where to focus their gaze to make their vision better.
Once this position is identified, they can be taught how to read again using the steady eye technique.
Instead of moving the eyes from left to right to read a sentence, the person should keep their eyes completely still and move the text to the left so that each word in turn moves into the area of best vision.
All UK patients with central vision loss should have the opportunity to try eccentric viewing
Mr Winfried Amoaku
Royal College of Ophthalmologists
Macular Disease Society chief executive Tom Bremridge said: "Eccentric viewing works by making the most of vision that remains.
"Our scheme has transformed lives - helping people to relearn basic skills they thought to have lost for good.
"We have 86 volunteer trainers, all with central vision loss themselves, who have trained more than 310 people in their own communities, and our waiting list of nearly 1,200 people grows every day.
"We are keen that other service providers - social services, private practitioners and primary care trusts - now take up the baton."
Mr Winfried Amoaku, of the Royal College of Ophthalmologists, said eccentric viewing could help some patients with central vision loss "cope with everyday tasks such as identifying coins while out shopping, watching television and reading".
"The trouble is, we don't know who will benefit until they have tried the training.
"All UK patients with central vision loss should have the opportunity to try eccentric viewing techniques to see if they can benefit," he said.
Marek Karas, of the Royal National Institute of Blind People, also supported the research advances.
"Although there is still ongoing discussion among experts over the best form of training for this type of therapy, we welcome with interest these latest developments."
Between 25 and 30 million people worldwide have macular degeneration. But as the population ages, this figure will rise.
It is estimated that the number of people affected will triple by 2025.
Eye Peripheral vision is retained
Partially sighted and registered blind people can be taught to read and see faces again using the undamaged parts of their eyes, say experts.
When only the central vision is lost, as with the leading cause of blindness, age-related macular degeneration, peripheral vision remains intact.
And patients can be taught to exploit this, the Macular Disease Society says.
It has developed a training scheme and is calling for professionals to adopt the system across the UK.
The macula is a small area of the retina at the back of the eye made up of specialist cells which process central vision as well as the fine detail of what we see.
Our scheme has transformed lives - helping people to relearn basic skills they thought to have lost for good
Tom Bremridge
Macular Disease Society
People with macular degeneration rarely go totally blind but even those with a relatively mild version of the disease cannot drive and have difficulty reading, recognising faces and watching television.
But studies show people can be taught to use their peripheral vision to fill in the gaps, using "eccentric viewing" and "steady eye techniques".
When someone with central vision loss looks directly at an object it may disappear, go faint, blur or distort. But when they look above, below or to one side of it, they see it more clearly.
Blind spots
Eccentric viewing helps people find exactly where to focus their gaze to make their vision better.
Once this position is identified, they can be taught how to read again using the steady eye technique.
Instead of moving the eyes from left to right to read a sentence, the person should keep their eyes completely still and move the text to the left so that each word in turn moves into the area of best vision.
All UK patients with central vision loss should have the opportunity to try eccentric viewing
Mr Winfried Amoaku
Royal College of Ophthalmologists
Macular Disease Society chief executive Tom Bremridge said: "Eccentric viewing works by making the most of vision that remains.
"Our scheme has transformed lives - helping people to relearn basic skills they thought to have lost for good.
"We have 86 volunteer trainers, all with central vision loss themselves, who have trained more than 310 people in their own communities, and our waiting list of nearly 1,200 people grows every day.
"We are keen that other service providers - social services, private practitioners and primary care trusts - now take up the baton."
Mr Winfried Amoaku, of the Royal College of Ophthalmologists, said eccentric viewing could help some patients with central vision loss "cope with everyday tasks such as identifying coins while out shopping, watching television and reading".
"The trouble is, we don't know who will benefit until they have tried the training.
"All UK patients with central vision loss should have the opportunity to try eccentric viewing techniques to see if they can benefit," he said.
Marek Karas, of the Royal National Institute of Blind People, also supported the research advances.
"Although there is still ongoing discussion among experts over the best form of training for this type of therapy, we welcome with interest these latest developments."
Between 25 and 30 million people worldwide have macular degeneration. But as the population ages, this figure will rise.
It is estimated that the number of people affected will triple by 2025.
Sunday, April 5, 2009
FDA Approval Recommended for Implantable Macular Degeneration Device
FDA Approval Recommended for Implantable Macular Degeneration Device
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: March 30, 2009
GAITHERSBURG, Md., March 30 -- An FDA advisory panel agreed that the agency should approve a miniature implantable telescope to improve central vision in elderly people with end-stage age-related macular degeneration.
The Ophthalmic Devices Panel voted unanimously Friday to recommend approval for the Implantable Miniature Telescope, made by Vision Care Ophthalmic Technologies, for use in patients who are 65 or older.
The thumbs-up came despite the device's association with loss of corneal cells over time.
Many elderly people would likely choose the telescope -- which could help maintain their ability to carry out daily tasks such as recognizing faces and reading books -- even if it meant developing corneal edema four or five years down the road, the panel decided.
Four years after the implant, about 15% of patients will have a significant depletion in endothelial cells, which can lead to corneal edema, according to an estimate by the panel's biostatistician, Karen Bandeen-Roche, Ph.D., of Johns Hopkins University in Baltimore.
The telescope works by directing light from the lens onto still-functioning portions of the macula to maintain central sight. It increases vision up to about three meters, helping patients perform close-up tasks, though doing nothing for their ability to drive.
The device would be implanted in one eye, after patients wear an external version for a few days to get a feel for it. Because it only improves central vision, implant recipients would rely on the opposite eye for peripheral sight.
The outcome of the Friday meeting was a major victory for the Vision Care, especially because the FDA turned down its original application in 2006 because of safety concerns.
New, longer-term data convinced the panel that the telescope can deliver improved vision for certain patients and that the associated cell loss is an acceptable risk.
Vision Care applied for a much narrower indication this time around. So narrow, in fact, that only about one-quarter of the participants included in the company's original trial would meet the new criteria, according to Henry Hudson, M.D., an vitreoretinal specialist in Tucson, Ariz., and lead investigator of the main clinical study submitted to the FDA.
The device was originally intended for patients 55 and older, but the sponsors bumped the age requirement up to 65. The new application also excludes patients with corneal guttata, and those who have an anterior chamber depth of less than 3 mm. Patients must also have retinal cell counts that are normal for their age group before receiving the implant.
The application calls for the device to be implanted by cornea specialists who are trained by Vision Care.
The panel's approval was based largely on a trial involving 206 patients with incurable central vision disorders and who were over 55 and had a need for cataract surgery.
The primary endpoint for efficacy was improvement of two lines or greater in either near or distance vision, which was achieved in 86% of patients at follow-up.
In a four-year follow-up that the company completed at the request of the FDA, 68% of the patients achieved a two-line or greater gain in either long distance or near vision four years after the surgery.
The panel heard from three octogenarians who said that if it weren't for their implantable telescopes, they would not be able to read books, make crafts, recognize their grandchildren, or carry out daily chores.
The committee suggested that the original trial cohort -- of which 130 are alive and still have the implant -- be followed for additional five years to monitor for complications such as rates of corneal transplant, retinal detachments and corneal edema.
The committee, chaired by Jayne Weiss, M.D., an ophthalmologist from the Kresge Eye Institute in Detroit, also said patients should be informed of the risk of cell loss and the possible benefits of improved central vision associated with the device.
The lead researcher agreed.
"The key consideration is proper patient expectation to get the maximum effect of this technology," Dr. Hudson said.
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: March 30, 2009
GAITHERSBURG, Md., March 30 -- An FDA advisory panel agreed that the agency should approve a miniature implantable telescope to improve central vision in elderly people with end-stage age-related macular degeneration.
The Ophthalmic Devices Panel voted unanimously Friday to recommend approval for the Implantable Miniature Telescope, made by Vision Care Ophthalmic Technologies, for use in patients who are 65 or older.
The thumbs-up came despite the device's association with loss of corneal cells over time.
Many elderly people would likely choose the telescope -- which could help maintain their ability to carry out daily tasks such as recognizing faces and reading books -- even if it meant developing corneal edema four or five years down the road, the panel decided.
Four years after the implant, about 15% of patients will have a significant depletion in endothelial cells, which can lead to corneal edema, according to an estimate by the panel's biostatistician, Karen Bandeen-Roche, Ph.D., of Johns Hopkins University in Baltimore.
The telescope works by directing light from the lens onto still-functioning portions of the macula to maintain central sight. It increases vision up to about three meters, helping patients perform close-up tasks, though doing nothing for their ability to drive.
The device would be implanted in one eye, after patients wear an external version for a few days to get a feel for it. Because it only improves central vision, implant recipients would rely on the opposite eye for peripheral sight.
The outcome of the Friday meeting was a major victory for the Vision Care, especially because the FDA turned down its original application in 2006 because of safety concerns.
New, longer-term data convinced the panel that the telescope can deliver improved vision for certain patients and that the associated cell loss is an acceptable risk.
Vision Care applied for a much narrower indication this time around. So narrow, in fact, that only about one-quarter of the participants included in the company's original trial would meet the new criteria, according to Henry Hudson, M.D., an vitreoretinal specialist in Tucson, Ariz., and lead investigator of the main clinical study submitted to the FDA.
The device was originally intended for patients 55 and older, but the sponsors bumped the age requirement up to 65. The new application also excludes patients with corneal guttata, and those who have an anterior chamber depth of less than 3 mm. Patients must also have retinal cell counts that are normal for their age group before receiving the implant.
The application calls for the device to be implanted by cornea specialists who are trained by Vision Care.
The panel's approval was based largely on a trial involving 206 patients with incurable central vision disorders and who were over 55 and had a need for cataract surgery.
The primary endpoint for efficacy was improvement of two lines or greater in either near or distance vision, which was achieved in 86% of patients at follow-up.
In a four-year follow-up that the company completed at the request of the FDA, 68% of the patients achieved a two-line or greater gain in either long distance or near vision four years after the surgery.
The panel heard from three octogenarians who said that if it weren't for their implantable telescopes, they would not be able to read books, make crafts, recognize their grandchildren, or carry out daily chores.
The committee suggested that the original trial cohort -- of which 130 are alive and still have the implant -- be followed for additional five years to monitor for complications such as rates of corneal transplant, retinal detachments and corneal edema.
The committee, chaired by Jayne Weiss, M.D., an ophthalmologist from the Kresge Eye Institute in Detroit, also said patients should be informed of the risk of cell loss and the possible benefits of improved central vision associated with the device.
The lead researcher agreed.
"The key consideration is proper patient expectation to get the maximum effect of this technology," Dr. Hudson said.
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