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Wavefront technology is not only used in wavefront lasik eye surgery itself, but also in the initial diagnosis. This diagnosis produces a 3-D map that can be used to guide the laser extremely accurately when the actual surgery is

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

carried out.

Studies that compare wavefront-guided lasik to conventional lasik have shown that a higher percentage of those undergoing wavefront guided lasik eye surgery achieve 20/20 vision without the aid of glasses or contact

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

Examples of combination products may in

enses compared to those treated without the assistance of wavefront technology.

And perhaps just as important, with wavefront technology there is less chance of suffering from problems such as a loss of visual quality, a loss of c

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

ontrast sensitivity and problems connected with night vision.

All eyes have some sort of imperfection, called an aberration. It is the degree of aberration that matters.

Lower-order aberrations are the ones you hear about most o

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

ten - myopia (nearsightedness), hyperopia (farsightedness) and astigmatism.

There are also higher-order aberrations, which account for about 15% of eye problems, and have exotic names such as coma, spherical aberration and trefoil

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

Combination pro

These aberrations cause problems that can include difficulty seeing at night, halos, issues with glare and blurred vision, and account for about 15% of eye problems.

Simply put, lower order aberration determine how much you see

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

, while higher order aberrations determine how well you see.

Unfortunately, ordinary lasik surgery increases the chance of higher order aberrations. With wavefront lasik eye surgery, however, while higher order aberrations still

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

increase they do so to a lesser degree than with conventional lasik.

What is Wavefront Technology?

Wavefront technology is a system that collects information about the eye from hundreds of separate points over the central 6 milli

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

metre area of the cornea. This creates a unique “map” that is specific to the eye being measured.

This information can then be linked to the laser to enable a completely customised and very accurate surgical procedure.

A furth

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

r advantage is that wavefront can help identify patients who are not good candidates for Lasik surgery. Lasik surgery is certainly not for everyone; it can in fact worsen existing visual problems, so the initial diagnosis is cruci

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

l.

What is a wavefront?

Wavefront technology has been used by astronomers for many years, but the first wavefront mapping of the eye was done in 1994. Towards the end of 2002 the Food & Drug Administration approved the Custom Co

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

Following aspects would a

rnea Wavefront Lasik.

In essence, a bundle of light rays enters the eye. When the light enters the cornea, the very front of those light rays is perfectly flat - like a sheet of paper. In a perfect eye, the light will be reflec

dd to the challenges in developing combination products:

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

ed back and exit still flat.

But of course, the light passes through an imperfect crystalline lens and so is distorted when it emerges. It is this distortion that creates the "map" that tells the specialist what problems exist

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

within the eye, how they can best be corrected, and provides the information is used to create the prescription that will be used to reshape the cornea.

How is Wavefront Technology Used?

When an eye specialist uses a conventional

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

instrument called a phoropter, he changes the lenses and then asks the patient which lens produces the best image. This process is subject to subjective feedback (what the patient thinks he is seeing as opposed to what he is really

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

seeing) and can only detect two eye abnormalities, these being cylindrical and spherical.

The cylindrical one causes astigmatism, while a spherical abnormality results in myopia (nearsightedness) or hyperopia (farsightedness).

Wa

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

Professional from academic institutions, pharmaceutical industries, health care indust

vefront technology, on the other hand, is much more accurate, measures many more points, and can detect an infinite number of aberrations.

There are limitation to the use of wavefront lasik eye surgery. If you are too myopic or

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

oo hyperopic, or have too much astigmatism, you will probably not be a candidate.

Thin corneas will be a problem, while having abnormally-large pupils may increase the risk of ending up with poor vision at night.

There is also th

.

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

e issue of cost. Most, if not all, doctors charge more for wavefront lasik eye surgery than for conventional. As a rough guide, expect to pay about $3000 and up per eye.

In summary - wavefront technology offers precise and indi

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

Companies that provide selfless information through particip

idualized prescriptions for Lasik eye surgery patients. If you meet the requirements, it also offers an increased probability that the resultant wavefront lasik eye surgery will provide a successful outcome with fewer side effects

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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