Advice Pool - Health and Fitness

There are few among us who, at one time or another, had not had to manage some level of impaired vision. Whether age has rendered us no longer able to see far away o

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

r up close, or we have suffered an illness or disease that has compromised our vision, it is likely that, if we have not already, we will someday need corrective mea

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

Examples of combination products may in

sures to help us see at our best.

And for those who have long managed the expense and inconvenience of eyeglasses and contact lenses, the idea of corrective eye sur

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

ery seems most appealing. It's no wonder, therefore, that Lasik eye surgery has continued to grow in popularity since it was first performed in the United States in

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

1991.

Lasik is relatively new on the scene to us – the consumers; but in actuality the technology has been a long time coming. In fact, in 1948, Columbian ophthalmo

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

Combination pro

ogist, Jose Barraquer first experimented with corneal procedures by actually surgically removing more than half of a patient’s cornea that he then froze. Once the co

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

rnea had been frozen to an appropriate temperature, Dr. Barraquer was able to reshape its surface thus removing barriers to clear vision.

Once the cornea had been r

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

shaped it was replaced into the patient’s eye. Such technology evolved by the 1960s to the point where such corneal procedures could be done without removing the cor

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

nea from the patient’s eye; this procedure was perfected and performed in Russia and involved the use of a scalpel.

Lasik began to take shape in the early 1980s whe

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

a U.S. ophthalmologist made alterations to laser technology that had begun to be used by the U.S. military. But in 1990, Lucio Buratto and Ioannis Pallikaris develo

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

ped the Lasik surgery that we know today by combining methods of two pre-existing techniques – keratomileusis and photorefractive keratectomy. Both keratomileusis an

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

Following aspects would a

d photorefractive keratectomy are techniques in which the cornea is reshaped with the use of an excimer laser or other technology.

The word Lasik refers to Laser-As

dd to the challenges in developing combination products:

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

isted In Situ Keratomileusis and is a form of refractive laser eye surgery that was first performed in the United States in1991. During the procedure, the patient’s

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

eye is immobilized with the use of a cornea suction ring after which the surgeon creates a flap through an incision made in the top layer of the corneal tissue.

The

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

flap is then lifted back to reveal the mid-section of the cornea – known as the stroma. The surgeon then uses a low-powered excimer laser to resurface the stroma. 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

e corneal flap made during the procedure is then replaced over the stroma; the healing process is natural and generally speedy. The procedure itself is very quick –

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

Professional from academic institutions, pharmaceutical industries, health care indust

sually less than 10 minutes an eye – and virtually painless. The most discomfort experienced by the patient is general anxiety in anticipation of the procedure.

Tod

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

ay, over one-million people in the United States alone have undergone Lasik surgery – generally with very good success. In fact, it is a very small percentage of pat

.

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

ents – less than 6% - who have experienced any complications following their procedure. Such complications generally include light sensitivity, dry eye, double visio

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

Companies that provide selfless information through particip

n, and scarring. These incidences, however, are very rare and can be greatly reduced by having your procedure performed by a reputable and experienced surgery center

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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