E-Articles - Health and Fitness

Poor eye sight is something which afflicts most people at some point in their lives. While for some people this means nothing more than wearing reading glasses as they approach

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

middle age, there are many more people who have been wearing glasses and contact lenses on a regular basis for so long that they can no longer recall what life with perfect vi

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

Examples of combination products may in

sion was like. For these people laser eye treatment – where the cornea is reshaped by a laser – may be an interesting proposition.

However, as laser eye surgery is an expensiv

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

e and permanent procedure it is not a decision to be taken lightly and there are many factors which need to be considered when weighing up the pros and cons before opting for t

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

reatment.

There is no doubt that laser eye surgery can change a person’s life in a very positive way. For around 90% of patients, laser eye treatment means that they no longer

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

Combination pro

require use of their glasses or lenses. After wearing glasses for many years, simple things such as waking up in the morning and being able to see the time on the alarm clock

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

without reaching for your glasses first, can bring a lot of pleasure. It should be noted, however that poor night vision and seeing a halo effect around lights are a normal sid

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

e effect of laser eye surgery which can make driving at night dangerous without using glasses. However, most patients consider this a small price to pay for perfect vision in t

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

he daytime.

Other than poor night vision – which may even be worse than it was prior to surgery – there are further negative factors which need to be considered when deciding

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

whether to commit to laser eye treatment. Common side effects include dry eyes, although after a six month course of eye drops most people find this condition improves. A minor

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

ty of patients, if they underwent Lasik, may also develop corneal infections. In some instances this may develop in the small flap which was cut in the cornea to allow the lase

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

Following aspects would a

r to reshape the tissue. Corneal ecstasia can occur if the cornea is weakened, as pressure can build up causing an unnatural bulging. Further surgery will be required to preven

dd to the challenges in developing combination products:

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

t vision loss.

There is also the risk of problems arising during surgery, although the likelihood of these occurring is very small. For instance, in Lasik the corneal flap may

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

become detached. In most instances this can be reattached once laser treatment is complete. In a rare number of cases damage occurs to the flap which prevents this. Vision los

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

s is possible in a failed operation, but thankfully is extremely uncommon.

Another factor in your decision should be your expectations. If you believe laser eye surgery will g

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

ive you 20/20 vision and you would not be satisfied if glasses were still required after surgery, the procedure may not be for you. Although the result is usually sufficient fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r the patient to go without their glasses – except perhaps at night time, as previously mentioned – the result is not always perfect. Under correction or over correction can oc

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

cur and it is much harder to achieve ‘perfect’ sight in patients whose vision is very poor. However, for some patients a substantial improvement in their sight is enough to jus

.

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

tify surgery, even if they can’t quite see the bottom line on the optician’s sight chart.

The best way to make your decision is to research laser eye surgery very thoroughly.

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

Companies that provide selfless information through particip

Consulting your optician or contacting a vision clinic which specialises in this treatment is a good way of obtaining information and finding out if it is a good choice for you

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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Although Cyprus joined the ECC in 2004, the Cyprus Government restricts the amount of property that foreigners may own, even Eu Nationals. This will change in 2009 but if you wish to purchase more than one apartment, house or villa as investments now then you need to find out how you can do so legally.

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E-Articles - Laser Eye Surgery – Weighing Up The Pros And Cons

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