Advice Pool - Health and Fitness

What are the possible effects of laser eye surgery? Laser eye surgery is not as risky as it used to be but it still does have plenty of risks assoc

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

iated with it. Many people are choosing this type of surgical procedure to correct their vision. It is important for anyone thinking about having e

; 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 surgery to be aware of the risks and possible outcomes of the surgery. Making an informed decision starts with discussing the possible outcomes

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

ith your surgeon.

Better Vision

Of course the ideal outcome is that you will come out of the surgery with better vision than before. Although it

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

s possible to have fully corrected vision and not need glasses at all any more, it is also possible that you will still need glasses to see at cert

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

Combination pro

ain distances. The ideal outcome for vision correction is to have your vision fully restored and no further need of glasses or contacts.

No Change

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

It is also possible that despite the surgeons best efforts you will walk away from the surgery clinic with little or no change in your eyesight. A

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

though this is very disappointing it can usually be rectified with an additional surgery. This is not very common but it is a possibility that you

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

hould be prepared for.

Worse Vision

Most people thinking of having laser surgery do not consider the possible result of having worse vision than

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

before. Even when their surgeon clearly states this as a possible result of the surgery many patients have a difficult time actually thinking this

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

ould happen to them. Often this type of outcome can be corrected through and additional surgery but it is possible that the damage to the eyes will

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

Following aspects would a

be permanent.

Full Vision Loss

Your ophthalmology surgeon will explain the worst possible outcome to you at your consultation appointment. Althou

dd to the challenges in developing combination products:

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

h it is extremely uncommon to have a laser surgery result in blindness, it is possible and you should be informed about this possible result of you

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

r surgery.

Infection

This is fairly uncommon but still can happen to anyone who is having corrective eye surgery. Your doctor may prescribe an an

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

ibiotic or antibiotic eye drop to help prevent an infection from occurring. If an infection does occur it is important to get it treated right away

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

to prevent damage to your eyes or your vision.

Finding out from Your Surgeon

Anyone thinking about having laser eye surgery should be aware of al

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

Professional from academic institutions, pharmaceutical industries, health care indust

the possible outcomes to their surgery. Doing your own research and educating yourself on the techniques, training, and results of laser eye surge

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

ry will be beneficial when you attend your consultation meeting with your surgeon.

At your consultation, feel free to discuss your concerns regard

.

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

ng the type of surgery you will be undergoing. An open discussion of the possible effects of eye surgery is the best way to gather the important in

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

Companies that provide selfless information through particip

ormation you need in order to make your decision. The Internet is another great resource tool for finding out more information on laser eye surgery

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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