E-Articles - Health and Fitness

We have all heard of LASIK surgery, there are also a number of other vision enhancement surgeries that are not as widely d

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

iscussed. For the most part, refractive surgery has been implemented to correct an eye for a single focal point.

If you a

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

Examples of combination products may in

e nearsighted, you can not see clearly in the distance. Refractive surgery would alter the surface of your cornea so you c

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

n now see clearly in the distance. By moving your focal point out, it also disrupts your near vision.

As a young 20 somet

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

ing, you probably won't even notice this effect. However, as a 40 something, you will definitely notice the difference. Ev

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

Combination pro

n someone who has had perfect vision through most of their life will find that they have trouble reading up close by the t

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

me they are in their mid to late 40's.

So altering a cornea with refractive surgery for a single focal point can not corr

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

ect both near and distance vision. With that said, there are some available workarounds. If you decide to surgically alter

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

your eyes, be sure you have done your due diligence and research regarding the both the surgical technique and the surgeon

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

One method that has been used for some time now is called monovision. The surgeon will correct one eye for distance and

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

he other eye for near vision. With both eyes open, you will be able to see clearly in all areas. Most people adapt very ea

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

Following aspects would a

ily to this type of vision. Just remember you are splitting up the team a little, so give your eyes a chance to adjust. Yo

dd to the challenges in developing combination products:

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

may want to evaluate monovision with contact lenses first to see if this is right for you.

Another procedure is called C

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

nductive Keratoplasty or CK. This method can also be used for a monovision effect. Heat is used to stretch the fibers of t

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

he cornea, altering the refractive surface. After someone with presbyopia receives CK, the treated eye is able to see at n

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

ar ranges while the untreated eye sees in the distance and mid range. This is still considered monovision, so evaluating v

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

Professional from academic institutions, pharmaceutical industries, health care indust

sion with contact lenses may be in your best interest if this surgery sounds interesting to you.

While these surgeries ca

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

certainly help you see up close without the use of contact lenses or glasses, remember that nothing is going to be perfec

.

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

. Much of refractive surgery success is based on the expectations of the person having the surgery. Have a thorough discus

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

Companies that provide selfless information through particip

ion with your eye doctor about what both your expectations are. And then make the decision that makes you most comfortable

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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