Advice Pool - Health and Fitness

We should understand who should do laser eye surgery as many people do not meet the medical criteria required for laser eye su

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

rgery. Laser eye surgery benefits certain people more than others; it is dependent on individual conditions. Remember, laser 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

ye surgery is not magic; it is a procedure. It is apt for people who have a problem involving cornea or the lens of the eye. I

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

f you are blind, laser eye surgery is of no use. Neither is it of any use if you have a vision problem that has to do with the

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

brain.

Laser eye surgery is for those who have problems of the eye, such as Myopia (nearsightedness), Hyperopia (farsightedn

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

Combination pro

ess), or Astigmatism. Laser eye surgery will not help people with age-related vision problems, such as presbyopia. Presbyopia

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

has nothing to do with the cornea and occurs when the lens becomes less flexible.

Candidate for Laser Eye Surgery
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
rong>

Let us assume you suffer from Myopia. This means you can see things that are close up, but cannot see distant objects c
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
learly. If your myopia has reached an extreme stage, then laser eye surgery may not be beneficial. In case of extreme astigmat
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
ism too, it does not work. Similarly, if you have a large pupil, it is of no use as the laser will not be able to reach where
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
it needs to. Laser eye surgery is beneficial to you if you have a normal bad vision.

You can go for laser eye surgery if your
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
eyeball has stopped growing. This is why younger people cannot go for laser eye surgery. The laser eye surgery cannot take ca
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
re of the future growth of the eyeball. Every person’s eye condition is unique; therefore indications and contra-indications c
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
an be ascertained only by pre-operative tests. If your eyes check out OK for laser surgery, there are other things to see befo
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
re the surgery are:

* You should be in good health.

* Your eyes should be in good health - no pus or random blood leakag
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
e.

* You should not have diabetes or other disorders that retard healing.

* You should not have undergone a previous
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
major eye surgery. This could cause unpredictable healing.

There are, basically, two different types of laser surgeries – th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
e Laser in-situ keratomileusis (LASIK) and Photorefractive Keratectomy (PRK). LASIK is more popular, and people prefer this. F
.

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
or undergoing LASIK eye surgery you must be 18 years of age, with stable glasses or contact lens prescription for at least two
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
years. You should avoid surgery if your medications include steroids or immuno-suppressants because this can prevent healing.

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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Advice Pool - Who Should Do Laser Eye Surgery?

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