E-Articles - Health and Fitness

Laser eye surgery is generally not very risky, but as with all operations, complicatio

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

ns can and do arise. The chances of having worsened vision because of the procedure is

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

Examples of combination products may in

very, very low, and to date there have been no cases of anyone going blind. Still, as

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

a patient you should be aware of the risks that come with the treatment.

Here are so

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

e risks that come with laser surgery:

Overcorrection and undercorrection. No one can

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

Combination pro

predict with complete certainty just how your eyes will respond to the treatment. Most

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

people do not attain perfect 20/20 vision as a result of laser surgery, but they do c

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

me close. If your vision has not substantially improved after the first procedure, you

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

may require a second one.

Regression. Some people lose the benefits of the surgery o

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

ver a period of time; their vision gradually worsens as time goes by. When this happen

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

, a second operation is often recommended.

Infection. There is a very small chance of

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

Following aspects would a

infection after surgery. Both PRK and LASIK surgery patients are at risk, but only mi

dd to the challenges in developing combination products:

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

nimally. If the cornea becomes infected, the healing of the eyes will be slowed and th

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

e patient will experience some discomfort.

Excessive Corneal Haze: Corneal haze often

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

appears after PRK and LASIK treatments. The haze usually has little effect on vision,

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

but in some cases it becomes excessive and interferes with eye function. An additional

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

Professional from academic institutions, pharmaceutical industries, health care indust

procedure is often required to correct excessive haze.

Procedural problems: Extenuat

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

ng circumstances may require that surgery be stopped at an inopportune time, as would

.

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

be the case of an earthquake, fire, or an equipment malfunction. This is more of a pro

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

Companies that provide selfless information through particip

blem with LASIK than it is with PRK, since the former requires more advanced equipment

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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