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Millions of people have successfully undergone corrective laser eye surgery and found it the answer to improving their vision without the use of

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

glasses or contacts. Massive advertising promotions led by the larger lasik surgical practices lead most to believe that the procedure is absolut

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

Examples of combination products may in

ly safe, quick, and effective. And for the vast majority of people it is.

Unfortunately it is easy to be seduced by the prospect of such a fairl

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

y easy solution to an ongoing vision problem. What many fail to fully realize is that lasik is in fact a surgical procedure, and as with any surg

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

cal procedure there are inherent risks and complications. While the percentage of complications from laser eye surgery tends to be relatively low

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

Combination pro

the wise consumer considering lasik still must take into account the possibility that things may not go as planned (or advertised).

Among the p

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

ossible complications from a lasik eye procedure are:

- Over or Under Correction. This is perhaps the most common complication from lasik surger

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

. It is generally a result of how the eye heals, and not a prescription error. The resulting condition can be corrected through glasses or contac

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

s (likely a great disappointment to the patient) or through a subsequent laser procedure known as an “enhancement procedure”.

- Night Glare and

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

Halos. This condition results in decreased vision at night and has several causes. While normal during the healing phase, continued problems can

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

e addressed through a variety of techniques.

- Epithelial ingrowth. This occurs when the outer cornea layer grows under the flap. While usually

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

Following aspects would a

nsignificant, a small number of patients will require further treatment. - Flap folds. Occur when the flap becomes wrinkled. A small number of pa

dd to the challenges in developing combination products:

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

tients will experience vision problems as a result of this and require repositioning of the flap.

- Inflammation (DLK). Inflammation can develop

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

where the flap makes contact with the eye and may result in photophobia (light sensitivity) and some loss of visual acuity. Causes are unknown, h

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

wever the condition must be treated to prevent damage to the eye.

- Ectasia. This occurs when the surface of the eye is weakened by an overly th

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

ick flap and can lead to eye bulging.

These are but a few of the more common complications. They are not intended to scare anyone away from lasi

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

Professional from academic institutions, pharmaceutical industries, health care indust

surgery. Your initial consultation with your surgeon will include a comprehensive eye examination which will help identify pre-existing eye cond

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

tions which may put you at greater risk of complications. Your surgeon may recommend alternatives to lasik based on your examination. However, ev

.

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

en though you may be determined to be a perfect candidate for lasik, the possibility of complications always exists.

As a consumer, most surpris

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

Companies that provide selfless information through particip

s may be avoided by simply learning as much about the procedure as possible beforehand, and then carefully choosing a competent qualified surgeon

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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