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Advice Pool - First LASIK – Now Super LASIK
What LASIK does
LASIK surgery uses a cool ultraviolet laser (called an excimer laser) to correct the shape of the cornea. This is the front surface of our eye, through which light rays pass on their way to the retina. They pass thro
LASIK surgery uses a cool ultraviolet laser (called an excimer laser) to correct the shape of the cornea. This is the front surface of our eye, through which light rays pass on their way to the retina. They pass thro
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ugh the lens behind the cornea, and form a tiny image on the retina, which is transmitted to the brain by the optic nerve.
Imperfect corneal shape
When the cornea is not perfectly shaped, the light rays bend at the wrong angle. The
Imperfect corneal shape
When the cornea is not perfectly shaped, the light rays bend at the wrong angle. The
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
n they don’t focus on the retina, but in front of it or behind it. This creates near- and far-sightedness respectively.
And when the cornea has little irregularities in its shape, the light rays come to the retina out of focus in ce
And when the cornea has little irregularities in its shape, the light rays come to the retina out of focus in ce
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
rtain areas, so that our vision has blurriness in different parts.
LASIK uses the excimer laser to vaporize tiny pieces of corneal tissue, so as to correct the corneal shape and surface. Then the light rays focus sharply on the reti
LASIK uses the excimer laser to vaporize tiny pieces of corneal tissue, so as to correct the corneal shape and surface. Then the light rays focus sharply on the reti
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
na and we see clearly.
Corneal flap
Before directing the laser beam on to the cornea to reshape it, the eye surgeon cuts a tiny flap on the corneal surface and bends it back to expose underlying tissue. The laser works on that tiss
Corneal flap
Before directing the laser beam on to the cornea to reshape it, the eye surgeon cuts a tiny flap on the corneal surface and bends it back to expose underlying tissue. The laser works on that tiss
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e and the flap is replaced, where it heals itself in a few days.
Not everyone is a good candidate for LASIK
If your corneas are too thin or too flat, LASIK is not a good answer.
Corneas too thin
In LASIK, the little flap is cut w
Not everyone is a good candidate for LASIK
If your corneas are too thin or too flat, LASIK is not a good answer.
Corneas too thin
In LASIK, the little flap is cut w
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
ith a device called a microkeratome. If your corneas are too thin, the eye surgeon may not be able to cut a good flap.
· In cutting it as thin as he can, he may inadvertently form it with a hole in it, so that some of what should be
· In cutting it as thin as he can, he may inadvertently form it with a hole in it, so that some of what should be
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
folded-back flap is still part of the cornea and will block the laser
· Alternatively, he may by mistake detach it altogether rather than folding it back. Then it may not heal as well.
· Or he may cut it too small in diameter for
· Alternatively, he may by mistake detach it altogether rather than folding it back. Then it may not heal as well.
· Or he may cut it too small in diameter for
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
the laser to have enough area to work on.
Corneas too flat
The purpose of LASIK surgery is to remove tiny pieces of corneal tissue to improve vision. But if the
Corneas too flat
The purpose of LASIK surgery is to remove tiny pieces of corneal tissue to improve vision. But if the
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
cornea is too flat, removing more tissue will make it even flatter, and this won’t improve vision. So people with extra flat corneas are not good candidates for LASIK surgery.
LASEK (E-LASIK)
LASEK (Laser Epithelial Keratomileusis)
LASEK (E-LASIK)
LASEK (Laser Epithelial Keratomileusis)
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
uses a different tool to create the tiny flap. It’s called a trephine and has an even finer blade.
· The eye surgeon uses the trephine to partly create the flap
· Then he covers the eye with a mild alcohol solution for a half-minut
· The eye surgeon uses the trephine to partly create the flap
· Then he covers the eye with a mild alcohol solution for a half-minut
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
e or so to loosen the flap’s edges
· Finally, he uses a tiny hoe-like tool to lift the flap’s edges and fold it back out of the way The LASEK procedure is then like traditional LASIK, using the excimer laser to remodel corneal tiss
· Finally, he uses a tiny hoe-like tool to lift the flap’s edges and fold it back out of the way The LASEK procedure is then like traditional LASIK, using the excimer laser to remodel corneal tiss
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ue, and the flap is carefully replaced.
Afterwards
The flap usually heals in a day or two and you may feel some eye irritation during this time. Many patients wear a “bandage” contact lens which holds the flap in place while it hea
Afterwards
The flap usually heals in a day or two and you may feel some eye irritation during this time. Many patients wear a “bandage” contact lens which holds the flap in place while it hea
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ls, but also allows oxygen to flow to the eye tissue.
After a week or so you’ll have your new vision. This is a longer time than after LASIK, when the results are immediately noticeable.
If you’re not a candidate for LASIK, you may
After a week or so you’ll have your new vision. This is a longer time than after LASIK, when the results are immediately noticeable.
If you’re not a candidate for LASIK, you may
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
do very well indeed with LASEK instead. Your eye surgeon will be able to explain why one procedure would be better for you than the other.
Epi-LASIK
In Epi-LASIK, the small flap is cut and excimer laser used to vaporize excess cor
Epi-LASIK
In Epi-LASIK, the small flap is cut and excimer laser used to vaporize excess cor
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
eal tissue, as in LASIK and LASEK.
But in Epi-LASIK, a plastic, oscillating blade is used to create the flap, rather than the microkeratome or the finer-bladed trephine.
And instead of using an alcohol solution to loosen the flap’s
But in Epi-LASIK, a plastic, oscillating blade is used to create the flap, rather than the microkeratome or the finer-bladed trephine.
And instead of using an alcohol solution to loosen the flap’s
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
edges before lifting it back, a very fine plastic blade is used, called an epithelial separator. Why?
Because in some cases, the alcohol solution can cause epithelial cells to die. An epithelium is a surface membrane, so in this co
Because in some cases, the alcohol solution can cause epithelial cells to die. An epithelium is a surface membrane, so in this co
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ntext, it refers to the surface cells on the cornea. The eye must grow more epithelial cells around the flap’s edges to reintegrate it with the rest of the corneal surface.
Epi-LASIK results
As with LASEK, vision improvement occurs
Epi-LASIK results
As with LASEK, vision improvement occurs
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
more slowly than it does after LASIK. For some, it’s evident after 3 or 4 days, and for others it’s not for 3 or 4 months.
But before Epi-LASIK, people with thin corneas were not able to have laser vision correction. Now they often
But before Epi-LASIK, people with thin corneas were not able to have laser vision correction. Now they often
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
can.
A quality eye surgeon is key in achieving excellent results from any laser eye surgery. Choose your surgeon carefully, asking lots of questions and considering not just the relative fees, but what you’ll receive for those fees
A quality eye surgeon is key in achieving excellent results from any laser eye surgery. Choose your surgeon carefully, asking lots of questions and considering not just the relative fees, but what you’ll receive for those fees
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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