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If you are thinking about getting Lasik Surgery, be aware that there are some slight risks involved. Although these risks only occur only 5% of the pat

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

ients, before getting Lasik surgery, take a look below at some of the pot ential complications.

Halo, this is one of the most common side effects assoc

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

Examples of combination products may in

ated with getting Lasik Surgery, this includes small glares, a halo’s that are associated with night vision and sometimes the patient may experience dry

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

eyes.

Under Corrected or Over Corrected Vision: When this occurs the patient will need further treatment or corrective lenses and or contact lenses. Th

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

e great news is that these complications do dissipate between a few days to 3-6 months after Lasik surgery. For more information it is best to ask your

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

Combination pro

octor and ask for stats from his or her patients.

Implantable Lenses for Natural Occurrences:
Although Lasik Surgery can correct vision, it does n

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

t prevent the onset of Presbyopia, which in laymen terms is the decline in vision that those in middle age and after experience. This can be noted when

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

one has to ready with corrective lenses. The best treatment and the most reliable treatment for Presbyopia is contact lenses. Some patients do not like

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

he daily hassles of messing with contact lenses, dry eyes, etc, and opt to have a lens implanted to replace their eye’s natural lens. This is an option

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

f you experience nearsightedness, which most common resulting from Presbyopia. From a professional and medical opinion this is the best option for those

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

whose vision cannot be corrected with Lasik Surgery. Now, on to more Lasik complications.

Light Sensitivity.
This complication is one of the most

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

Following aspects would a

common of those who undergo Lasik surgery. This side effect will generally last around 5 days after Lasik Surgery.

“Starbursts”, Glare and the Infamou

dd to the challenges in developing combination products:

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

Halo

These are classified as general vision problems when the flap of the corneal does not correctly adhere after replacement. This side effect wi

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

l disappear after the first month. Another cause for this is when the pupil will dilate larger than the previous treatment zone.

Dry Eyes

This sid

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

e effect shows itself through redness of the eyes, sometimes blurred vision, itchiness of the eye, eye crusting, or the false sensation that an object i

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

in the eye such as dust or dirt.

Astigmatism

This is when the cornea becomes warped as a result of Lasik sugery, this warping is due from scarrin

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

Professional from academic institutions, pharmaceutical industries, health care indust

and results in a complete failure of the Lasik surgery. Those who experience this side effect will still have to wear corrective lenses.

The great new

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

s about these side effects is that the further advances in Lasik technology can reduce the amount of these side effects. Infact there this a new Lasik p

.

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

ocedure call Intralasik which is bladeless and uses a laser. The result is less complications with the flas that can cause Astigmatism. Since these new

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

Companies that provide selfless information through particip

evelopments, the risks for the above side effects diminish rapidly and as science and technology drive forward less instances will be noted by patiences

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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