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PRK (Photorefractive Keratectomy) was the forerunner of Lasek laser eye surgery. It has been around for over 12 years and is therefore considered a safe procedu

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

re as to date there has been no evidence to suggest that PRK causes harm to eyes and vision in the long term. However, it is now much less commonly used than La

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

Examples of combination products may in

sek treatment and Lasik, which at present is the most popular form of laser eye surgery.

The most frequent reason for a laser eye surgery practitioner to recom

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

mend PRK over the other forms of treatment is that the patient has an unusually thin cornea or a large pupil. In these in instances, PRK is the safer option as

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

Lasik works through a flap being created in the cornea and Lasek treatment is enabled by softening the cornea with an alcoholic solution. Both of these forms of

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

Combination pro

treatment become much more complex if the cornea is too thin.

During preparation for surgery, the eye area will be cleaned thoroughly and the eyelid held in pl

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

ace with a metal ring. Anesthetic drops are administered t numb the eyes to prevent discomfort during the use of the laser. Unlike other types of laser eye trea

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

tment, where the shape of the eye is reformed underneath the surface of the cornea, PRK works by reshaping the cornea by eliminating a thin layer of cells from

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

the surface of the eye with an excimer laser. The epithelium will grow back naturally and no undue side effects should result from its temporary removal.

Altho

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

ugh PRK is a safe procedure its downside, in comparison to newer forms of laser eye surgery, is that recovery time can take longer and PRK patients generally ex

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

erience greater pain and discomfort. Vision may remain hazy or slightly blurred for up to two months, when the final effects of laser eye treatment should becom

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

Following aspects would a

e noticeable. Dry eyes are a common side effect and eye drops should be used to keep the eyes lubricated and free from infection.

As with all forms of laser ey

dd to the challenges in developing combination products:

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

e surgery, PRK carries certain risks. For instance, while daytime vision may be improved sufficiently for the patient to go about their daily routine without gl

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

asses or contact lenses, dark conditions can be a problem. Night vision may be even poorer than it was pre-surgery and it is very common for patients to see a g

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

lare or ‘halo’ around lights. This can make driving at night inadvisable, at least of the first few months, and after this time glasses may be required for driv

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

ng after dark.

Although laser eye surgery is permanent, patients need to remember that their vision can still deteriorate as part of the ageing process and tha

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

Professional from academic institutions, pharmaceutical industries, health care indust

t, at some point in the future, they may once again have to wear glasses or contact lenses. Your chances of attaining good results from laser eye treatment will

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

be greatly increased if you suffer from only mild to moderate near or long sightedness and the longevity of the results can be extended if your prescription ha

.

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

s remained stable for several years.

Despite the popularity of newer treatments such as Lasik, PRK can still be a viable option with a number of advantages, in

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

Companies that provide selfless information through particip

particular its reputation as a safe procedure. Only a qualified ophthalmologist can advise you which type of laser eye surgery is most suitable for your needs

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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