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The days in which eyeglasses and contact lenses were the only option to those with impaired vision came to an end in 1991 when Lasik eye surgery was first pe

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

rformed in the United States. Today, with more than a million patients having undergone the procedure, Lasik has become commonplace among eye patients who wi

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

Examples of combination products may in

h to minimize the long term expense and inconvenience associated with eye care. Lasik is something of a miracle for those who have struggled with compromised

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

vision. And while it may be something that is relatively new to us, it utilizes technology that has actually existed for quite some time.

Lasik eye surgery

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

focuses on the reshaping of the eye’s cornea – the transparent tissue that covers the iris (the colored segment of the eye) and the lens (the part that rests

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

Combination pro

behind the iris). The lens is the part of the eye that bends or refracts light to the retina – cells that exist in the lining of the back of the eye. The ret

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

na’s job is to then take that light and convert it to messages that can be received by the optic nerve in the brain.

When the eye experiences refractive dif

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

ficulties – such as what is experienced in nearsightedness, farsightedness, astigmatism, and a host of other issues – the light that our eye receives is not

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

efracted properly and the message that our brain receives is that of a blurry image. Traditionally, eyeglasses and contact lenses have been utilized to corre

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

t how light is refracted by our eye. But modern times have seen the rise in popularity of Lasik eye surgery – that makes such corrections with the aid of a l

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

ser.

Experimentation with surgically correcting the cornea first began in the late 1940s when a Columbian ophthalmologist was able to successfully treat pat

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

Following aspects would a

ients by removing over half of their cornea, freezing it, resurfacing it once it was frozen, and then replacing it in the patient’s eye. In the 1960s, an oph

dd to the challenges in developing combination products:

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

halmologist in Russia was able to elevate the technology by making adjustments to the cornea while it remained in the patient’s eye; such adjustments were ma

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

e using a scalpel.

In 1990, Lucio Buratto and Ioannis Pallikaris developed Lasik eye surgery; the first of which was performed in the United States in 1991.

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

Lasik stands for Laser-Assisted In Situ Keratomileusis and makes correction to the cornea to improve light refraction. During Lasik eye surgery, the patient

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

is first given numbing drops to anesthetize the eye. The patient lies down and the eye is held open with a speculum and immobilized with a cornea suction rin

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

Professional from academic institutions, pharmaceutical industries, health care indust

. The surgeon then cuts a thin flap into the top layer of the cornea. The flap is folded back to reveal the underlayer of the cornea – the stroma. Using low-

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

powered laser technology, the surgeon then resurfaces the stroma to improve light refraction. When the procedure is completed – normally in less than 10 minu

.

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

es – the flap is replaced over the cornea and allowed to heal naturally.

Most patients report virtually no pain during Lasik eye surgery and only mild and i

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

Companies that provide selfless information through particip

frequent discomfort. Recovery time is short; patients can generally resume normal activities – with a few safety guidelines – the day following the procedure

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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