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Although laser eye surgery can greatly enhance a person’s life, deciding to undergo the procedure can be quite daunting. It is normal to be nervous bef

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

ore undergoing any form of surgery, but in the case of laser eye surgery the fear can be increased as patients are conscious during the procedure and u

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

Examples of combination products may in

nder normal circumstances most people would be unwilling to allow a laser beam near such a delicate area of their body. Although nothing is likely to 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.

ompletely calm pre-operative nerves, educating yourself about what happens during the procedure can help build your confidence.

During surgery, patien

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

ts lie in a reclining chair directly beneath the laser. To allow the surgeon to operate the eye lids are fixed in place with a metal ring. While this i

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

Combination pro

s not uncomfortable in itself, being unable to blink can be a little disconcerting for the patient. The eye is thoroughly cleansed and drops are used t

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

o anaesthetise the area. From the start of preparation time to the conclusion of laser treatment generally takes around 15 minutes.

Lasik

In L

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

asik surgery, a small incision is made in the cornea to produce a small flap. This leads to vision loss for about 20 to 30 seconds. The laser – which i

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

s programmed before the operation starts – will then reshape the cornea. The procedure is not painful but can be quite unsettling due to the smell of b

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

urning that occurs when the laser comes into contact with the surface of the eye.

As complications can arise as a result of the incision, Lasik is con

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

sidered the highest risk of the different forms of laser eye surgery, although it also has many advantages, for example a greatly improved recovery tim

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

Following aspects would a

e. One of the problems which may arise during surgery is that the cornea may become detached. However, in most instances, the surgeon is able to reatta

dd to the challenges in developing combination products:

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

ch the cornea after treatment is complete.

Lasek

Lasek varies from Lasik in that no incision is made. Instead, after the eye area has been pre

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

pared for surgery an alcoholic solution is used to soften the epithelium, which is then folded to one side to allow the laser to reshape the cornea. On

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

ce the procedure is complete, this will be pushed back into place. A contact lens will be placed over the cornea to hold the epithelium in place. This

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

will need to be worn for several days.

In a small number of cases PRK is used instead of Lasek, particularly if the patient has an unusually thin corn

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

Professional from academic institutions, pharmaceutical industries, health care indust

ea or large pupils. The procedure is very similar, but an excimer laser removes a thin layer of cells from the surface of the cornea and the eye is the

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

n reshaped to allow better focusing. This is not painful, although PRK often experience more discomfort than those undergoing other forms of laser eye

.

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

treatment. The protective layer of cells will grow back naturally in the weeks following surgery.

If you have concerns about laser eye surgery, or are

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

Companies that provide selfless information through particip

anxious about what to expect, do not hesitate to contact the vision clinic. The staff will be happy to answer your enquiries and alleviate your fears.

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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