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Advice Pool - Which is More Important, the Laser or the Surgeon?
What is a laser?
It’s a man-made light beam. There are many types and they’re named according to how they’re made, e.g.
· Gas lasers, such as the CO2 laser which is used in skin resurfacing
· Gas lasers, such as the CO2 laser which is used in skin resurfacing
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
· Solid state lasers, such as the nd:YAG laser made with a ruby cylinder, which are the most powerful lasers, and
· Semiconductor lasers, which have less power and are used in laser printers
; 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
CD players, etc.
Laser light is different from other kinds of light, such as headlights, flashlights, street lights, etc.
· It’s coherent – the light waves are parallel with each other and
· It’s coherent – the light waves are parallel with each other and
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
can travel far without spreading out like a flashlight
· It’s directional – because it’s coherent, it can be highly focused
· It’s monochromatic – it contains only one color, as opposed to
· It’s directional – because it’s coherent, it can be highly focused
· It’s monochromatic – it contains only one color, as opposed to
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hite light which contains all colors. They can be within our visual range of color, infra-red, or ultra-violet
Lasers were first made in the 1950s, but not until the 1990s were they used for
Lasers were first made in the 1950s, but not until the 1990s were they used for
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ision correction.
Excimer lasers
Excimer lasers are the type used by eye doctors. They’re a type of gas laser and their name is a contraction of “excited” and “dimer” (a “dimer” is a pseudo-
Excimer lasers
Excimer lasers are the type used by eye doctors. They’re a type of gas laser and their name is a contraction of “excited” and “dimer” (a “dimer” is a pseudo-
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
molecule which gives off ultraviolet light when it’s in an excited state).
Excimers are non-thermal lasers. That means there’s no danger of any burn to the eye tissue. They’re used for PRK an
Excimers are non-thermal lasers. That means there’s no danger of any burn to the eye tissue. They’re used for PRK an
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
LASIK procedures.
Photorefractive Keratectomy (PRK) Treatment
PRK was developed in the early 1980s but was not done in the U.S. until the FDA approved it in 1995. It uses an excimer laser t
Photorefractive Keratectomy (PRK) Treatment
PRK was developed in the early 1980s but was not done in the U.S. until the FDA approved it in 1995. It uses an excimer laser t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
o correct lower-order aberrations –
near- and far-sightedness and astigmatism.
This procedure is short. You’re positioned beneath the laser and a retainer is placed over your eye to keep i
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
open. Your eye doctor uses anesthetic eye drops so you’ll feel no pain. He’ll remove a tiny amount of tissue from the surface of the eye, the cornea, and the laser will correct the exposed ti
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
sue, smoothing it to correct your vision.
Wavefront-guided LASIK
The remarkable advance of Wavefront-guided LASIK
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
is that it can correct not only the lower-order aberrations, but also the higher-order aberrations like halos, glare and night vision trouble.
The laser itself is part of an integrated works
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
ation which includes a highly adjustable patient chair along with the microscope, computer, and controls of all kinds for your eye doctor to operate with. Both the mapping and the correction a
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
re done by this system.
Wavefront mapping
As you lie back in the workstation chair, the excimer laser first does the mapping work. The light wave is sent through your iris to the retina at t
As you lie back in the workstation chair, the excimer laser first does the mapping work. The light wave is sent through your iris to the retina at t
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
e back of the eye, from which it bounces back to a sensor. It carries information with it, based on what happened to it as it traveled through the eye’s cornea (outer surface).
From this info
From this info
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
mation, the system makes a 3-D map of your eyeball, which will show your eye doctor what needs to be corrected. The system translates this information into mathematical formulae which your eye
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
doctor will program into the computer that controls the laser beam.
Vision correction
As you continue to lie back in the patient chair, your doctor proceeds with the laser correction. To di
As you continue to lie back in the patient chair, your doctor proceeds with the laser correction. To di
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ect the laser to the tissue immediately below the cornea’s surface, he cuts a thin flap of tissue and bends it back. The laser then removes tiny pieces of tissue that were affecting your visio
.
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
n, modifying the shape of your cornea. The tiny flap is replaced and heals by itself.
Laser and doctor work together
The precision of the laser and the education and skill of the doctor make
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
a formidable team that plays on your side. Whether you have PRK treatment or Wavefront-guided LASIK, choose an experienced eye doctor and you can then be sure that he’ll use the laser expertly
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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