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Recent encouraging news about the long term results of lasik surgery will no doubt please the 1.4 million Americans who elected to have Lasik vision correction surge

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

ry last year.

The Food & Drug Administration (FDA) is still cautious; it believes that laser companies have not yet presented enough evidence to enable final conclu

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

Examples of combination products may in

ions about the effectiveness or the safety of enhancement surgery.

However, the recent news is encouraging. The American Academy of Opthalmology was told at its a

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

nual meeting in November 2006 a follow-up study of people who had undergone lasik and PRK (photorefractive keratotomy)10 years earlier was very positive.

The resear

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

hers found that while there had been some regression, on average patients had maintained 20/25 vision.

A 2005 Irish study of patients who had had lasik surgery in 1

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

Combination pro

998 and 1999 was also positive. There had been some regression, but surgeons had been able to correct eye defects with a great deal of accuracy, and there was a hi

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

h level of patient satisfaction.

The popularity of the lasik option for people who depend on eyeglasses or contacts therefore appears to be wellfounded, and the res

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

lts can often be dramatic.

Some 95 % of all patients report improved vision almost immediately. Quite often eyesight improves to 20/40 or better.

The first modern

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

asik surgery was performed in America in 1991, so many surgeons now have nearly 20 years experience, and equipment and techniques are continuously improving.

Still,

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

the FDA is cautious. Its website notes that "Long-term data is not available. Lasik is a relatively new technology. The first laser was approved for Lasik eye surg

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

ry in 1998. Therefore, the long-term safety and effectiveness of Lasik surgery is not known."

Lasik surgeons agree, and caution that lasik is surgery, and therefore

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

Following aspects would a

some risk.

The FDA list of potential problems is sobering:

Some patients lose lines of vision (on the eye chart) that cannot be corrected with glasses, contact len

dd to the challenges in developing combination products:

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

es or further surgery;

Some patients have troubling side effects that can include glare, halos or double-vision. Situations of low contrast, such as driving in fo

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

g or at night, can become a real problem for those who lose some visual acuity ("sharpness"), even if they have 20/20 vision;

Patients may be over- or under-treated

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

which may require further surgery, called enhancements, to correct;

Patients may develop severe "dry eye" problems;

Results are generally not as good in patients

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

ith very large refractive errors - although this is an issue that most surgeons will highlight at the very first examination, and will probably recommend against las

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

Professional from academic institutions, pharmaceutical industries, health care indust

k in such circumstances.

The FDA is worried that the benefits of improved vision may not be permanent. While the recent studies support the view that there may be

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

a gradual regression, but it does appear to be just that - gradual.

There is always the possibility that even with the surgery, a patient may still need to wear gla

.

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

ses; this will be particularly true of older patients.

On balance, therefore, the new findings suggest that as long as you have investigated the issues properly, yo

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

Companies that provide selfless information through particip

have chosen your surgeon carefully, you understand the potential side effects, and you are a good candidate, you can count on achieving good lasik long term results

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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