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Fortunately, the great majority of patients do not regress after LASIK surgery. The curvature of the cornea should remain reasonably stable shortly after the first few months.

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

Using computerized topography to map the cornea shows us that most LASIK patients achieve a stable refraction within the first three months after surgery. However, some pati

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

Examples of combination products may in

nts with high myopia, may require up to six months or longer to stabilize.

Patients who do experience a drop in the effectiveness of the procedure usually were severely myopic

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

before surgery. Doctors are still puzzled as to why these patients occasionally regress. The best that can be surmised is that the problem is most likely related to the depth

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

of the laser ablation, and the healing process. The more laser treatment necessary, the more remodeling necessary by the stroma or middle layer of the cornea. This remodeling

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

Combination pro

takes place during the first couple of years after surgery. Also, the epithelium may regrow a little thicker over the lasered area, especially in highly myopic patients. In o

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

der to overcome large amounts of nearsightedness, the laser must make a deeper ablation. The deeper the laser treatment, the more the body will attempt to fill in the surgical

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

depression, or "divot," with new epithelium. In highly myopic patients, this natural healing response may contribute to slight-to-moderate post-surgical regression.

LASIK sur

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

ery will neither slow down, or speed up the normal progression of nearsightedness. As a result of this, some myopic patients naturally continue to get a little more nearsighted

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

throughout their life. Even though the corneal curvature is stable, should the eyeball become slightly longer, or if the crystalline lens begins to develop a cataract, the per

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

on will become more myopic . No matter how much the natural progression of near-sightedness progresses over time, patients still should have better vision without glasses afte

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

Following aspects would a

r LASIK surgery.

For example, consider a thirty-year-old man with -7 diopters of myopia. With or without surgery, he may naturally develop another diopter of refractive error

dd to the challenges in developing combination products:

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

over a five-year period. Without the surgery, his correction would now be -8 diopters (severe myopia). However, let's say he had LASIK surgery at thirty years old, and his co

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

rection was reduced to -1 diopter (mild myopia). The five years pass and his eyeball naturally elongates so that his refractive error increases to -2 diopters. This is much

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

etter than the -8 severe myopia that would occur without LASIK surgery.

Scientists have noticed, and it does make obvious sense, that people doing large volumes of close work

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

end to be more myopic. People who work outdoors, such as construction workers, who must focus in the distance are less likely to be severely myopic. As you may know, when you

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

Professional from academic institutions, pharmaceutical industries, health care indust

have to focus on a near object, your eyes will converge. Having been pulled inward during years of reading, there is a good chance your eyeball could become slightly longer.

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

he slightest increase of only 1 millimeter in the length of the eyeball can increase myopia by up to 3 diopters. Think of it like this; when you squeeze a tennis ball and quic

.

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

ly let it go, it will pop right back to its original shape. Should you squeeze the tennis ball sixteen hours a day for ten years, it is not unreasonable to expect that the ten

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

Companies that provide selfless information through particip

is ball's shape could elongate slightly.

Investigate the benefits of LASIK surgery carefully to fully understand the chances of regression.

Copyright 2006 Carl DiNello

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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E-Articles - What Are Your Chances Of Regression After LASIK Surgery?

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