Advice Pool - Health and Fitness

LASIK (laser assisted in-situ keratomileusis ) is probably the most commonly performed laser eye surgery procedur

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

e and tends to be what people think of when considering laser surgery for vision correction. However not all patien

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

Examples of combination products may in

s may be ideal candidates for LASIK surgery due to variations in cornea thickness and curvature. Photo refractive k

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

ratectomy ,or PRK, may be the better option for vision correction in some patients who are not able to have LASIK

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

Prior to the introduction and subsequent popularity of LASIK, PRK was the most common refractive eye surgery proc

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

Combination pro

dure performed. Both LASIK and PRK share similarities in that an excimer laser is utilized to sculpt and reshape th

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

cornea of the eye in accordance with the patients medical needs. Both techniques are used in the correction of myo

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

ia (nearsightedness), hyperopia (farsightedness), astigmatism(blurred vision resulting from corneal irregularity),

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

or a combination thereof. Likewise, both are outpatient surgical procedures which may be performed in a physicians

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

ffice or clinic setting. There are however a few differences in the two procedures.

In a LASIK procedure a small f

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

ap is cut with a special tool on the exterior of the cornea. The computer controlled excimer laser is then used to

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

Following aspects would a

eshape the corneal tissue under the flap. The flap is then replaced over the cornea where it will adhere to the eye

dd to the challenges in developing combination products:

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

and serve to protect it. In PRK, the excimer laser is used to remove tissue and reshape the cornea directly on the

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

urface, or epithelial layer, of the eye. A protective soft contact lens is usually placed over the eye for 3-5 days

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

to allow the epithelial surface to heal. Several major differences for the patient exist in the two procedures. Th

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

first is the recovery period, which tends to be considerable shorter for LASIK patients as opposed to PRK. Likewis

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

Professional from academic institutions, pharmaceutical industries, health care indust

, vision improvement with PRK tends to be more of a gradual process than take from a few days to a few months. LASI

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

patients will in most circumstances experience the benefits of their surgery in a much shorter frame.

A successfu

.

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

end result for both procedures is an improvement in vision, and the correction of pre-existing vision conditions.

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

Companies that provide selfless information through particip

nly a thorough examination and consultation with a qualified laser eye surgeon can determine which is right for you

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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Advice Pool - LASIK vs PRK Eye Surgery

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