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Are you tired of your poor vision? Have you spent years wearing contact lenses or correctional eye wear, only for your vision to con

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

tinue to decline as time passes? Do you dream of a day where you can live uninhibited by glasses or contact lenses but worry because

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

Examples of combination products may in

you suffer from astigmatism, myopia, hyperopia, or perhaps other irregularities, and are afraid this can keep you from going ahead w

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

th any correctional procedures?

Wavefront LASIK (laser-assisted in situ keratomileusis) could be the answer to your concerns. This

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

rocedure, basically considered a custom form of the widely-used LASIK surgery, goes deeper than traditional LASIK by using special e

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

Combination pro

uipment to take 3-dimensional measurements that better guide the laser used in surgery as it reshapes your cornea and fixes most, if

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

not all corneal irregularities your eyes may have.

Because wavefront laser surgery was originally geared towards people with modera

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

e-to-severe vision defects, it is necessary to be screened and qualified for the procedure before being allowed to undergo the corre

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

tion. There are guidelines set up by the FDA that need to be taken into consideration, as well as factors such as your corneal thick

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

ess and degree of irregularities. And while traditional LASIK surgery itself can help correct common defects, wavefront LASIK and Wa

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

eprint mapping software has opened the doors so that even those with less-common and more serious eye irregularities can take part i

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

Following aspects would a

a life less-dependent upon vision correction through the use of contact lenses or prescription glasses.

The number of patients cho

dd to the challenges in developing combination products:

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

sing custom LASIK procedures over more traditional LASIK surgery is growing, given the fact that wavefront LASIK gives the opportuni

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

y for better results and less chance of post-surgery complications such as impaired night vision and seeing halos and glare coming o

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

f of light sources. The chances of achieving 20/20 vision (or perhaps even better than 20/20 vision) is also much greater due to the

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

care taken to custom-map the procedure to your eye's ability to process what it sees in the world around you. And with wavefront LAS

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

Professional from academic institutions, pharmaceutical industries, health care indust

K, the chances of your vision declining as time goes by is also diminished.

Custom LASIK -- because it is a custom procedure and re

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

uires more in-depth treatment and use of special equipment unnecessary to traditional LASIK surgery -- costs anywhere from $100 to $

.

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

00 more than normal LASIK surgery, meaning an average estimated cost of approximately $1800 per eye. But, given the advantages of cu

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

Companies that provide selfless information through particip

tom LASIK to the traditional procedure, many people seem to believe the extra money spent on custom wavefront LASIK is well worth it

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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