Advice Pool - Health and Fitness

What is a laser?

It’s a type of light beam which is man-made for a certain purpose. There are many types of lasers, named according to how they’re created, e.g. solid state lasers, gas

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

lasers, and semiconductor lasers.

They all have some features in common which differentiate them from other types of light, such as sunshine, flashlights, neon lights etc.

· They’re di

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

ectional – very focused, rather than diffuse like a flashlight.

· They’re monochromatic – they contain only one color, as opposed to white light which contains all colors. They can be w

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

thin our visual range of color, infra-red, or ultra-violet.

· They’re coherent – the light particles, or photons, all move in step with each other and create wavefronts that begin in un

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

son.

CustomVue uses the Visx Star S4 excimer laser. Excimer lasers are named from “excited” and “dimer” and use a mix of reactive and inert gases to create the laser light (a “dimer” is

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

a pseudo-molecule which gives off ultraviolet light when it’s in an excited state).

How is the laser used for vision correction?

The Visx S4 laser is used at two stages of vision corre

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

tion:

· Diagnosis

· Corneal reshaping

Before your vision can be corrected, detailed information must be garnered from a scan of each of your eyes. This is done using Wavefront technol

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

ogy called the WaveScan WaveFront System, which:

· Was FDA-approved in 2002

· Measures imperfections in your eye with extreme precision

· Produces a detailed map of your eye

· Genera

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

es digital information which will be used to guide the laser in correcting your eyesight What does Wavefront mean?

Light is thought of as traveling in waves (although sometimes it’s th

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

ught of as traveling in particles, but that’s another discussion).

· The Wavefront system sends a wave of light through your iris to the back of your eye, the retina

· The wave then bo

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

nces off the retina and returns to the system, bringing digital information about the contours of your eye

· Using this information, the system makes a 3-D map which can be seen on its

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

omputer screen

· The system also generates mathematical formulae which your eye doctor uses to guide the laser in correcting your vision

What’s meant by higher order aberrations?

Ther

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

are different kinds of imperfections that can be found in our eyes, causing imperfect vision. These imperfections are referred to as aberrations, and are divided into two groups:

· Low

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

r order aberrations – nearsightedness, farsightedness and astigmatism

· Higher order aberrations -- haloes, glare and double vision (which particularly show up in night vision)

Eye doc

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

tors have been able to correct for lower order aberrations for many years. The higher order aberrations can now also be corrected, using a laser system.

What makes CustomVue a better pr

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

cedure?

Precision. When you have this procedure done, the visual correction is unique to you. Because the WaveScan technology can obtain such exact measurements of your eye’s contours,

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

t can guide the laser with precision in correcting them.

This means that you can potentially achieve the full potential of your vision and be even better than 20/20. The Visx company di

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

a study as part of applying for FDA approval, and found that a year after having CustomVue procedures:

· All study participants passed driving tests without glasses or contacts

· 98%

.

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

f them could see 20/20 or better without glasses or contacts

· 70% of them could even see 20/16 or better without glasses or contacts

A CustomVue procedure is comfortable and easy. The

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

system is an integrated workstation which includes a highly adjustable patient chair along with the microscope, computer, and controls of all kinds for your eye doctor to operate it with

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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Every action has its consequences. And every procedure we have performed on out bodies will, in some way, leave an effect. Some of the effects are intentional, and some are unintended side effects. Some side effects are temporary; our bodies can recover from them. And some are permanent. But side effects, good or bad, almost always accompany the desired effects of our chosen procedures.

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