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Let’s face it, going “under the knife” is not something any of us look forward to. Wouldn’t it be great if you could get that Lasik eye surgery w

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

ithout going under the knife?

California Lasik eye surgery, which can cost thousands of dollars and usually aren't covered by insurance, grew in

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

Examples of combination products may in

popularity during the 1990s but slowed amid the 2001 recession. The numbers are slowly rising again, but some patients are squeamish about having

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

blades inserted into their eyes, experts say.

Santa Ana-based Advanced Medical Optics Inc. thinks it can move more people to have the procedure

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

by cutting the blade out of the process.

On Monday, the company announced plans to buy Irvine-based IntraLase Corp. for $808 million. IntraLase

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

Combination pro

makes a machine that allows doctors to do Lasik without a blade. I don’t know about you but the though of someone putting a knife to my eyes is

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

ot the most appealing thing I can think of.

Lasik, or laser-assisted in-situ keratomileusis surgery, is a two-step procedure in which a flap is

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

cut in the cornea, traditionally with a blade. Then, a laser is used to reshape the eye so it can properly refract light.

IntraLase's technology

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

introduced in 2001, allows what is called an "all-laser Lasik," a more expensive procedure that now accounts for about a quarter of Lasik proced

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

ures, according to Market Scope, a St. Louis-based market research company.

How much better the results are with an all-laser procedure is still

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

being debated, said Mark Dlugoss, editor of the trade publication Ophthalmology Times.

As most in the field agree, lasers make a more accurate c

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

Following aspects would a

ut, which leads to fewer chances of complication, Dlugoss explained. But in the decade or so that Lasik surgeries have been around, doctors and b

dd to the challenges in developing combination products:

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

ades have improved as well.

However marginal or significant the advantages of laser, the technology is still convincing to patients who are skit

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

tish about having sharp metal objects drawn to their eyes, even if in the hands of doctors, Dlugoss said.

"It is definitely a selling point," he

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

said.

For Dr. Roger Steinert's patients, it already is the standard.

"Within a few years, you won't see [blades] anymore," said Steinert, one o

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

f the nation's pioneers in Lasik surgeries and a professor of ophthalmology at UC Irvine and director of its UCI Refractive Surgery Center, which

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

Professional from academic institutions, pharmaceutical industries, health care indust

has offices in Orange and Irvine.

Lasik surgeries cost on average $1,950 per eye, according to Market Scope. An all-laser procedure adds $400 fo

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

r each eye.

"Most patients realize that when your eyes are at stake, this is not the time to look for the blue-light special," said Steinert, wh

.

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

added that when he started using IntraLase three years ago, many of his patients who were once skittish about Lasik decided they were now ready.

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

Companies that provide selfless information through particip

The bottom line is that the world Lasik eye surgery is changing and California eye surgery is on the cutting edge, if you pardon the expression

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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