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LASIK is a procedure that is used to correct refractive errors in the eye. Refractive

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

errors are imperfections in the eye’s focusing power, and the procedures used to cor

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

Examples of combination products may in

rect them are, as a group, called refractive surgery. LASIK is one type of refractive

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

surgery. In LASIK, a special laser is used to remove corneal tissue, reshaping the c

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

ornea in order to improve its focusing power.

There are three types of refractive er

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

Combination pro

ors. These include: astigmatism, hyperopia, and myopia. Astigmatism is a distortion o

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

f the image on the retina caused by irregularities in the cornea or lens of the eye.

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

Hyperopia, more commonly known as farsightedness, causes people to have more difficul

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

ty seeing objects that are nearer to them, as opposed to objects that are farther. My

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

opia, or nearsightedness, causes the exact opposite effect. Shortsighted people have

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

hard time seeing objects that are farther off. Combinations of astigmatism and short

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

Following aspects would a

sightedness and astigmatism and farsightedness are quite common, and most people use

dd to the challenges in developing combination products:

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

contact lenses to compensate for these imperfections.

There are also three types of

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

refractive surgery. Aside from LASIK, there is Radial Keratotomy (RK), and Photorefra

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

ctive Keratectomy (PRK). In RK, an exceptionally sharp knife is used to change the sh

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

pe of the cornea. The aim of a PRK procedure is to re-shape the cornea as well, but i

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

Professional from academic institutions, pharmaceutical industries, health care indust

t uses a laser to do achieve this effect. LASIK is quite similar to PRK in this regar

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

d. The only difference lies in the how they treat the stroma. In a PRK procedure, the

.

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

top layer of the cornea is scraped away to expose the stromal layer underneath. In c

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

Companies that provide selfless information through particip

ontrast, in a LASIK procedure a flap is cut in this layer and the flap is folded back

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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