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Help your eyes last for a lifetime. Though your risk of certain eye conditions increases with age, you can often prevent or delay problems by knowing your risks

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

and taking care of your eyes. Here’s a primer on eye care for common conditions:

Cataracts

This happens when the normally c

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

Examples of combination products may in

lear lens of the eye becomes cloudy. It develops gradually, affecting about half of Americans after age 65.

Symptoms

Blurre

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

d or dim vision, greater sensitivity to glare, need for brighter light for reading and other activities.

How to see better

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

urgery can replace the clouded lens with a clear lens implant. “Surgery is low risk and high benefit,” says Dr. Gottlieb. Multifocal replacement lenses are now a

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

Combination pro

vailable. They produce clear vision and reduce or eliminate the need for reading glasses. You may be able to delay the need for surgery by wearing sunglasses tha

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

t block ultraviolet (UV) light.

Macular Degeneration

A deterioration of the tissue in the part of the retina responsible fo

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

central vision. Doctors perform a dilated eye exam to diagnose early changes in the macula.

Symptoms

With macular degeneration, patients noti

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

ce a loss of central vision, the need for increasingly bright light to read, difficulty recognizing faces or visual distortions. The dry kind is most common; the

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

wet kind, which involves bleeding in the macula, is most destructive to vision.

How to see better

Although the damage cann

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

t be reversed, your doctor can perform one of several outpatient procedures to slow or even stop the progress of the disease. Foods rich in antioxidants, such as

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

Following aspects would a

leafy green vegetables and fruits, can help prevent or delay the development of macular degeneration. It’s also important to wear sunglasses that block UV rays,

dd to the challenges in developing combination products:

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

to stop smoking, to manage conditions such as high blood pressure and to get regular eye exams.

Glaucoma

A group of diseas

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

es, glaucoma involves damage to the optic nerve, usually accompanied by abnormally high pressure in the eyeball.

Symptoms

Glaucoma causes blin

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

spots to develop in your vision, starting with peripheral vision. If not treated, you may develop tunnel vision and eventually lose your sight. 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
g>

How to see better

While you can’t reverse or cure glaucoma, you can control it through a variety of therapies, including eyedrops, oral med
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
ications and, rarely, surgery. Most patients can control glaucoma “by taking just one prescription eyedrop a night before going to bed,” says Marguerite McDonald
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
M.D., clinical professor of ophthalmology at Tulane University medical school in New Orleans. Cholesterol-lowering drugs may also be beneficial. Regular eye sc
.

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
reenings are critical for detecting glaucoma before damage has occurred. While not every eye disease can be prevented, early detection is the key to managing th
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
em. Getting good eye care now can keep you seeing clearly in the years ahead. --Barbara Crow ©MediZine's Healthy Living, Second Quarter 2007

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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