Advice Pool - Health and Fitness

For those of us who deal with the ramifications of less than perfect vision on a daily basis, we know how much our routines can center on maintaining our eyewear; f

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

rom uncomfortable glasses that get in our way, to contact lenses that dry our eyes and always seem to go missing at the most inopportune moments. And when you add t

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

Examples of combination products may in

o that the expense of vision treatment for those who wear glasses or contacts, it can be downright frustrating. But what most people have come to discover is that c

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

orrective laser eye surgery – a procedure that takes less than an hour and costs considerably less than a lifetime of vision correction prescriptions – can not only

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

perfect your vision but address a number of eye conditions with which many people suffer.

Corrective laser eye surgery can allow you to finally have the vision yo

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

Combination pro

u have always wanted; most patients are able to achieve 20/20 vision even immediately following the procedure. For those who have suffered with poor vision their en

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

tire lives, this can be a miracle procedure. And for those who suffer from such degenerative conditions as dry eye – wherein sufferers experience itchy, burning eye

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

, glaucoma, cataracts, and macular degeneration, corrective laser eye surgery can be a saving grace.

When most people think of corrective laser eye surgery they im

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

mediately think of Lasik surgery – a popular procedure that is used to correct vision. But the truth is that corrective eye surgery is rather like an umbrella phras

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

e under which all manner of corrective procedures fall. Lasik is indeed one of the procedures that falls under this umbrella and is considered to be an excimer lase

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

r procedure – through which the cornea of the eye is reshaped by laser. Lasik – and the procedures like it - correct nearsightedness, farsightedness, and astigmatis

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

Following aspects would a

m. The difference between the various excimer laser procedures is the type of laser that is used and the technique that is followed depending on what particular pro

dd to the challenges in developing combination products:

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

cedure is likely to bring you the most success based on the condition and shape of your eyes.

Non-excimer laser procedures are another group that falls with correc

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

tive laser eye surgery. Such procedures involve one of three things: the insertion of permanent lenses into the eye, the reshaping of the eye using laser energy or

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

radio waves instead of lasers themselves, or the actual cutting of the eye. These procedures are meant for those who experience severely compromised vision or catar

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

acts.

Other corrective eye surgery may include more complex and comprehensive procedures such as cornea transplants during which healthy tissue from a donor eye is

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

Professional from academic institutions, pharmaceutical industries, health care indust

transplanted into the eye of someone whose own cornea has been compromised due to injury or illness. There is also a procedure that is used to treat Keratoconus –

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

or the bulging of the corneas; during this procedure the surgeon places plastic inserts (Intacs) onto the corners of the cornea to flatten them.

Not surprisingly,

.

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

as technology continues to advance, corrective laser eye surgery continues to make similar advancements. More and more people have come to discover that it is no lo

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

Companies that provide selfless information through particip

nger necessary to live with permanent vision impairment. If you feel that you may be a candidate for such procedures, see your eye doctor for a thorough examination

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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