E-Articles - Health and Fitness

Three of the more common vision problems are referred to as refractive errors. A refractive error is basically an er

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

ror in the focusing of light by the eye. The most common refractive errors include hyperopia (farsightedness), myopi

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

Examples of combination products may in

(nearsightedness), and astigmatism (blurred vision due to corneal irregularities).

Hyperopia, or farsightedness re

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

ults when light entering the eye focuses behind the retina instead of directly on it. This is often due to a cornea

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

hich is flatter than a normal eye. An individual with hyperopia will experience difficulty seeing objects that are

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

Combination pro

lose and may experience eye strain and headaches after reading or doing close work. The condition will generally wor

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

en with age , as the eye loses its ability to compensate. Correction for hyperopia usually involves corrective eyegl

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

asses, contact lens, or refractive laser eye surgery.

Myopia, or nearsightedness, occurs when the eye focuses in fr

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

nt of the retina as opposed to directly on it. This effect is generally caused by a cornea that is steeper than a n

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

rmal eye. Typical symptoms are blurry distance vision which may make the reading of highway signs, blackboards, etc.

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

difficult. It is estimated that as much as a third of the population may suffer from myopia. Correction for this di

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

Following aspects would a

order may be obtained with prescription eyeglasses, contact lens, or through refractive laser surgery.

Astigmatism

dd to the challenges in developing combination products:

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

ccurs when the cornea is more oval, or football shaped, than spherical. The corneal surface may in addition have som

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

areas which are flatter or steeper than others. Dependent upon the degree, symptoms of astigmatism may include di

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

stortion in areas of your field of vision, blurring of lines, eyestrain, and headaches. It may exist along with othe

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

refractive errors as well. Treatment is generally through prescription eyeglasses, contact lens, or refractive las

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

Professional from academic institutions, pharmaceutical industries, health care indust

r eye surgery.

Most refractive vision errors may be corrected with eyeglasses or contact lens. A more permanent sol

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

tion for many individuals exists with a laser eye surgery procedure such as LASIK. In many cases a laser surgical pr

.

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

cedure can eliminate the need entirely for glasses or contacts. In any case, it is of extreme importance that any an

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

Companies that provide selfless information through particip

all vision problems be thoroughly assessed by a qualified opthamologist who can advise the best course of treatment

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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