Advice Pool - Health and Fitness

Laser eye surgery has been such an enormous boon for the "seeing-eye" world that thousands of people with defective sight problems can thank this relatively simple and

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

quick procedure for restoring their sight to acceptable and satisfying levels. But are you aware that their are risks associated with laser eye surgery?

It's foolhar

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

Examples of combination products may in

dy to think that any type of surgery is risk free and laser eye surgery is no different. The question you have to ask yourself is whether the benefits of having this t

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

ype of procedure outweigh the risks and in most cases patients will choose the former.

The good news is that the chances of suffering serious vision-threatening side

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

ffects from laser eye surgery are extremely low. But there are risks nevertheless and you should be aware of them.

What Are The Side Effects?

Corneal infection is al

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

Combination pro

ways a possibility following procedures such as Photorefractive Keratectomy (PRK) and Lasik. However, the risk is so low that when it's presented as a possible worst c

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

ase scenario to patients, they generally dismiss it as non-threatening. The percentage factor is something like 0.1 per cent which is extremely low. Those who experien

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

ce it will suffer no long term effects and it usually means a slower healing process and some extra discomfort. It's hardly reason for concern considering the benefits

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

from receiving the surgery.

Corneal infection aside, one of the more common side effects of laser eye surgery is what is termed as under or over correction. What does

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

this mean? Simply put, it's difficult to predict exactly how a patients eyes will respond to treatment so in some cases, corrective lenses may be needed in the short

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

term or further surgical treatment is scheduled.

Dry Eyes

Dry eyes are another side effect of laser eye surgery but again, it's not sight threatening and can be trea

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

Following aspects would a

ted easily with lubricating drops. Patients are generally more worried about the inconvenience of the extra healing time which can amount to several weeks.

PRK patien

dd to the challenges in developing combination products:

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

s in some instances will report a condition known as corneal haze. Corneal haze occurs during the recovery process and while it is not threatening in the majority of p

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

rocedures, there is always the possibility that vision could be impaired somewhat if the haze becomes excessive. As a prospective patient, you should be made aware of

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

this but again, it shouldn't affect any decision you may make in going ahead with surgery.

Lasik Risks

Flap damage is a risk for lasik patients. The worst case scena

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

rio is that the flap could be irrepairably damaged or even lost however, once again the chances of this occurring are extremely low. Another risk for lasik patients in

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

Professional from academic institutions, pharmaceutical industries, health care indust

olves the possibility of suffering a distorted corneal shape which may occur during healing. If this occurs, it will have some impact on the overall quality of vision.

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

If you are concerned about the side effects of laser eye surgery then you need to discuss them with your surgeon. We've covered a few but there are others, including

.

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

a condition known as regression. It simply means that the eye may retreat to it's former state following surgery. This could occur several months following the proced

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

Companies that provide selfless information through particip

ure and further surgery may need to be scheduled. The bottomline... yes, there are risks associated with surgery but in the world of "laser eye" they are extremely low

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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