Advice Pool - Health and Fitness

About 120 million people in the United States wear eyeglasses or contact lenses to correct nearsightedness, farsightedness, or astigmatism. This article

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

will outline some refractive errors that cause people to wear vision correction devices, and may lead to their decision to have laser eye surgery.

The v

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

Examples of combination products may in

sion disorders, called refractive errors, occur when the curve of the cornea is incorrectly shaped (too steep or too flat) for the length of the eye. Whe

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

the cornea has a correct shape and curvature, it bends light onto the retina with precise focus. However, when the curve of the cornea is not correct, i

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

bends the light so it is not sharply focused on the retina, making images appear blurry. By placing corrective lenses, either glasses or contacts, in fr

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

Combination pro

nt of the cornea, the light is bent slightly to compensate for the refractive error of your cornea.

Myopia, or nearsightedness, affects more than 25 per

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

ent of all adult Americans. When the cornea is curved too steeply, or if the eye is too long, faraway objects will appear blurry because they are focused

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

in front of the retina.

Hyperopia, or farsightedness, is the opposite of myopia. Distant objects are clear, and close-up objects are blurry. With hyper

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

pia, images focus on a point beyond the retina. Hyperopia results from an eye that is too short or a cornea that is too flat.

Astigmatism is a condition

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

in which the uneven curvature of the cornea blurs and distorts both distant and near objects. A normal cornea is round, with even curves from side to sid

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

and top to bottom. With astigmatism, the cornea is shaped more like the back of a spoon, curved more in one direction than in another. This type of curv

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

Following aspects would a

ng causes light rays to have more than one focal point and focus on two separate areas of the retina, distorting the visual image. Two-thirds of American

dd to the challenges in developing combination products:

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

with myopia or hyperopia also have astigmatism.

Presbyopia commonly affects people as they enter their 40s, and it occurs as the lens inside the eye be

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

omes less flexible and the muscles controlling the lens weaken. People with presbyopia may experience blurred vision when performing everyday "close-up"

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

tasks, such as reading, sewing, or working at the computer. This is why some people with presbyopia need reading glasses or need to hold objects farther

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

way to see them.

Correcting the curvature of the cornea is different for each condition previously mentioned. Glasses and contact lenses are designed to

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

Professional from academic institutions, pharmaceutical industries, health care indust

compensate for the refractive errors caused by myopia, hyperopia, and astigmatism. Many people, however, want to reduce their dependency on glasses and c

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

ntacts. The reasons people find eye glasses or contact lenses are diverse.

There are a number of highly advanced surgical procedures available that effe

.

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

tively reduce the need for glasses or contact lenses. However, not everyone is an ideal candidate for these procedures. It is best to consult an experien

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

Companies that provide selfless information through particip

ed laser eye surgeon in your area to see if you are a good candidate. For more information read another article of mine titled "Different Types of LASIK.

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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