E-Articles - Health and Fitness

According to leading eyecare industry research firm Jobson Research, 6 in 10 people in the U.S. need vision correction. That means approximately 72% of adults (age 18 and older) need vision correction. As the Baby Boomer bubble continues to

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

age, the number of 40-something adults that will creep into this category will increase due to the inevitable onslaught of presbyopia - an age-related condition that causes difficulty focusing at close range.

Until recently, wearing glasses wa

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

Examples of combination products may in

s the only non-surgical option for roughly 80%-85% of those needing vision correction, with contact lenses accounting for only 15%-20% of the vision correction prescribed. In the early days of contact lenses, wearers had to tolerate rigid, un

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

comfortable lenses that were rather expensive and not very conducive to an active lifestyle. Those days are long gone.

Today, new materials and technologies have made wearing contact lenses a real possibility for nearly all of the vision cor

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

rected population. Today's contact lens manufacturers have developed new lenses to correct most vision disorders, including myopia (nearsightedness - difficulty seeing objects at a distance), hyperopia (farsightedness - difficulty seeing near

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

Combination pro

objects), astigmatism (astigmatism means that the cornea is oval like a football instead of spherical like a basketball - this causes light to focus on more than one point in the eye, resulting in blurred vision.), and presbyopia.

Contact le

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

nses have historically been able to correct myopia and hyperopia, but an irregular shaped cornea had made fitting contact lenses either very expensive or somewhat problematic, until recently. Similar issues arose when trying to fit contact le

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

nses for a bifocal spectacle wearer (presbyopia). However, new technologies have made fitting these conditions commonplace. The fitting process is more involved, and as such, you can expect the professional fees and the cost of the lenses to

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

be a little higher than the standard one-size-fits-most spherical lens, but the trade-offs for most wearers who now can experience the freedom from glasses is well worth it.

A note of caution here: not all eyecare professionals are equally s

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

killed when it comes to fitting "specialty" contact lenses. Some of these may even tell you that you are not a good candidate because they lack the proper skills to fit you properly. In some cases, there may be a medical reason why you are

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

ot a good candidate, such as chronic dry eye. In such cases, it is not a bad idea to have your eyecare professional provide you a written list of contraindications to contact lens wear and then get a second opinion from a contact lens special

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

Following aspects would a

ist.

Another development worthy of mention here is the advent of silicone hydrogel contact lens materials. Contact lenses made from a silicone hydrogel material allow significantly higher oxygen transmissibility (Dk/t) through the lens to yo

dd to the challenges in developing combination products:

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

ur eye. This means the wearing experience is healthier and generally more comfortable than lower Dk/t conventional hydrogel contact lenses. Additionally, many silicone hydrogel contact lenses are FDA approved for "continuous wear." This mea

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

ns it is okay to sleep in them without the risk of doing damage to your eyes.

There are currently two brands of silicone hydrogel contact lenses approved for up to 30 days and nights of continuous wear: CIBA Vision's Night & Day and Bausch &

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

Lomb's PureVision contact lenses. Night & Day lenses have the highest oxygen transmissibility of any lens currently on the market and are available to correct myopia, hyperopia and mild-to-moderate astigmatism. PureVision's lenses have a lowe

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

r Dk/t, but are available in spheres (corrects myopia, hyperopia and mild-to-moderate astigmatism), torics (to correct astigmatism) and multifocals (to correct presbyopia).

If you are new to contact lenses, or even a veteran wearer of conventi

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

Professional from academic institutions, pharmaceutical industries, health care indust

onal hydrogels, talk to your eye doctor and let them know you are interested in silicone hydrogel options. Even if you are happy wearing a lower Dk/t lens, the long-term health benefits to getting more oxygen to your cornea outweighs the old

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

saying, "If it ain't broke, don't fix it." Transitioning from a lower Dk/t lens to a high Dk/t silicone hydrogel may take from a few days to a few weeks until your eyes adjust to the different feel of these lenses plus the new infusion of ox

.

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

ygen that they have not been used to with conventional hydrogels.

Silicone hydrogel contact lenses have been touted as the single most important development in contact lenses in the past 20 years by several leading medical experts in the fiel

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

Companies that provide selfless information through particip

d. With so many positive new technologies and materials available, now is a good time to visit your eye doctor and see if contact lenses are right for you. Chances are good that you will be able to say goodbye to glasses and hello to freedom

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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