E-Articles - Health and Fitness

The eye is like a camera. Within the eye, just behind the pupil, is a lens, like a lens inside a camera. This natural lens of the eye should be clear. If the lens becomes cloudy and obscures vi

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

sion this is called a cataract. The only “cure” for a cataract is surgery to remove the cloudy natural lens and replace it with a clear artificial lens; called a “lens implant”. But at what poi

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

Examples of combination products may in

nt should the operation be done?

The timing of a cataract operation should be tailored to the individual’s visual requirements. Some will need and want their cataract removed sooner than other

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

s. For example if the person wishes to continue to drive then a cataract will need to be removed when it is still relatively mild. Early surgery may also be appropriate if the cataract is affec

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

ting the individual’s ability to perform their job safely and effectively, or if it is spoiling the enjoyment of their hobbies and past times. However if the person has less demanding visual re

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

Combination pro

quirements then it may be appropriate to leave the cataract until it is more advanced. The decision to operate or not should be based on the particular circumstances and wishes of each patient.

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

There are not fixed rules about the timing of surgery.

Each individual should consider how much difficulty their cataract is causing them. Their optometrist or doctor may have spotted some ca

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

taract but if the patient is having no vision problems then surgery is probably not needed. Cataract on it own is rarely harmful to the eye. Sometimes the patient may be aware of impaired sight

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

but can cope safely with all their needs of daily living and may not wish to undergo surgery. This is quite acceptable. On the other hand if the individual is bothered by even mild cataract it

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

may be entirely appropriate to remove it. In such circumstances there is no need to wait until it gets worse or becomes “ripe” or “mature”. The days of that approach are long gone.

There are

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

hough sometimes special factors that may influence the timing of cataract surgery. If there is some other disease or abnormality within the eye then surgery may need to be delayed, or performed

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

Following aspects would a

as soon as possible, or may not be worthwhile at all. Which of these applies will depend on the exact nature of the other condition. If the cataract is in an only eye, then the small risks of

dd to the challenges in developing combination products:

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

surgery must be considered very carefully. The chance of an only eye suffering serious surgical complications is remote but the consequence could be devastating. Again each case must be conside

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

red on it own merits setting the risks of surgery against the likely benefits. Generally speaking though one would hesitate a little more before removing a cataract from an only eye, but if the

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

visual impairement is significant then surgery may still be the right thing to do.

Very rarely a cataract may be directly harmful to the eye or vision. This can occur if the cataract is parti

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

cularly advanced (“hyper-mature”), or physically large. In these circumstances it should usually be removed quickly.

Having been given the necessary information by their eye specialist in the

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

Professional from academic institutions, pharmaceutical industries, health care indust

end the decision to opt for surgery, or not, rests with the patient. It is often helpful and reassuring to discuss the issues with family and friends. No one should be arm twisted into having c

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

ataract surgery. Keep in mind though that most cataracts develop slowly and there is a creeping compromise to vision. If this occurs simultaneously in both eyes there is a faded memory of what

.

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

vision used to be like. The affected individual may not fully appreciate what they are missing. It is often with amazement and surprise that they realize, after the cataract has been removed, h

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

Companies that provide selfless information through particip

ow bright and colourful the world really still is. So if your vision isn’t what it used to be because of cataract and there is no particularly good reason not to have it fixed why go on waiting

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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