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It's considered extremely safe...laser eye surgery and the benefits are enormous for those who have gone under the laser in recent years. While laser

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

eye surgery is very safe, there are still risks which you should be aware of as there is with any type of surgical procedure.

It's important to compa

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

Examples of combination products may in

re the benefits to any negatives from eye surgery. Provided you qualify, the final decision will be yours so don't be influenced too much by friends a

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

nd family who have undergone the procedure successfully in the past.

Laser Eye Surgery Risk

Let's not try to portray too negative an image of laser

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

ye surgery. Undoubtedly, you will be going in with eyes wide open and aware of the risks involved and by the time you are in the operating chair, you

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

Combination pro

will have weighed up all the pros and cons and will be happy with your decision. Here are some of the associated risks which could occur:

- vision lo

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

ss
- visual symptoms
- regular follow ups as a result of under or over treatment
- dry eyes
- diminishing results

Side Effects Of

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

Laser Eye Surgery

Let's examine the risks in a little more detail. Always keep in mind the success of this procedure is very high but the following

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

an occur in some instances.

Under or over treatment is an interesting side effect and this is usually a frequent occurrence. What this means is perfe

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

ct vision without the aid of visual aids only occurs in a small percentage of patients. Further post operative treatment may be required while if a pa

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

tient wore glasses before the surgery, there is a strong chance they will still be required to wear them after the procedure.

Visual problems such as

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

Following aspects would a

loss of vision and symptoms such double vision and halo effects are serious side effects which are not too common. However, they still can occur. Vis

dd to the challenges in developing combination products:

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

on loss of some description is a real blow as it usually cannot be reversed with further surgery.

Many patients will go in with high expectations giv

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

en the feedback they received and the excellent success record of laser eye surgery but this in itself is a risk. Keep your expectations at a realisti

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

c level and discuss with your surgeon exactly what you could reasonably expect from the surgery.

Dry eyes and diminished results are two more risks t

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

o consider. Dry eye syndrome is a result of the eye being unable to produce moistness and this can be an extremely uncomfortable time for the patient.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Results diminishing over time is a factor particularly for those with far sighted vision.

Eye Surgery Technology On The Improve

There may come a tim

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

e when laser eye surgery risk is non existent given the rapid rate in which technology is advancing. Right now though, the risk is always there and lo

.

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

nger term side effects are still a little unclear. However, the benefits most patients have experienced through this type of procedure during the past

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

Companies that provide selfless information through particip

ten years has been remarkable and remember, if you are deemed an eligible candidate for eye surgery, the final decision is always in your lap to make

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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