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Contact lens and eyeglasses exams are getting easier and easier. New advances in eye examination procedures provide the doctor with a starting poi

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

nt on the eyeglass prescription and a detailed analysis on the shape of the front of the eye. One such instrument is the autorefractor, a computer

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

Examples of combination products may in

that estimates the prescription of the eye within a few seconds.

The glaucoma test is often done using an instrument that blows a puff of air in

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

your eye to determine your eye's internal pressure. The test is helpful in detecting glaucoma but is not conclusive in ruling it out. Eye pressure

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

s can fluctuate during the course of a day and ideally pressures should be measured in the morning and again in the afternoon when there is concer

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

Combination pro

about high pressure.

Dilation of the eye is a procedure that allows the doctor to temporarily open the pupil in order to view the back of the ey

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

e. This procedure is helpful in evaluating for glaucoma, macular degeneration, diabetes, retinal detachment and many other diseases.

Visual Field

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

testing is a sophisticated computerized instrument which allows the doctor to test the sensitivity of the retina and optic nerve. This is valuabl

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

in assisting the early detection of many eye diseases including glaucoma, optic neuritis, macular degeneration and some neurologic lesions.

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

ong>HOW TO PREPARE FOR AN EYE EXAM You need to do more than just make an appointment for an eye exam. You also need to gather information

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

that will help your optometrist assess your eye health and vision, and provide you with good vision for your varied lifestyle. Write down your ans

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

Following aspects would a

wers to these questions and give the information to your optometrist when you go for your exam.

What chronic health conditions, such as h

dd to the challenges in developing combination products:

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

igh blood pressure, diabetes or allergies do you or any close family members have? Your eyes can be affected by your general health.

What

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

eye health problems, like glaucoma, run in your family?

What prescription and non-prescription medications are you taking? Drugs sometime

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

s can affect your eyes and vision.

How do you use your eyes for work? Make note of the tasks that you do, how long and how often you do t

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

em, the distance between your eyes and each task, and details about your work environment. Such information helps the optometrist determine the ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

act prescription and any special lens design needed to give you sharp, comfortable vision on the job.

What are your hobbies and sports? Y

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

our optometrist can help you decide whether or not you need a special pair of eyeglasses or safety glasses for your hobby or sport.

What

.

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

roblems are you having with your eyes? Some symptoms are blurred vision, difficulty changing focus from far to near and visa versa, squinting, dou

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

Companies that provide selfless information through particip

ble vision, seeing floaters or flashes of light, headaches, difficult seeing at night or in dim light, burning or itching or tired eyes.

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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