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Presbyopia

The lens, behind the iris, is normally adjusted by little muscles, which make it more curved or more flat, depending on how far away the object is that we’re looking at. But with age, the

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

lens becomes more stiff and harder to adjust; and the little muscles become a bit weaker. So when we look at the print in our book, our lenses can’t adjust properly, and stay set for looking at the

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

Examples of combination products may in

ree at the back fence, and the print appears blurry. That’s where bi-focals, whether glasses or contact lenses, are useful, because they correct for close-up vision while correcting differently for f

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

r vision, or not correcting it at all. Disadvantages of glasses
· They’re so easily misplaced
· They have to be modified periodically as we age and our vision changes
· If you work in

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

a job where you change focus often, such as teaching, sales, performing arts or public speaking, glasses can be very inconvenient and annoying

One eye on the horizon

The idea of monovision is t

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

Combination pro

correct one eye for the distance vision and the other for close-up vision. In cases where distance vision needs no correcting, just the near-vision eye would be corrected.

Eye doctors started doing

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

his with contact lenses. They made one lens to correct distance vision and the other to correct near vision. When LASIK surgery came along in the late 1990s, some people chose to have one eye correcte

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

d for distance and the other for close-up work. This means that the two eyes don’t work together any more. As you can imagine, this takes some getting used to, but it can be done.

An upside down wor

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

d

A related experiment was done in the late nineteenth century by George Stratton. He wore special glasses which turned everything upside down, so that he saw the floor where the ceiling would normal

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

y be, and vice versa, and all objects correspondingly upside down. He found that it only took about 3 days to adjust, so that things looked normal again. In other words, things didn’t look upside do

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

n, but looked just as they normally do. Then he took the glasses off and found everything looked upside down again. So again it took him a few days to re-learn and restore his normal vision.

Our br

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

Following aspects would a

ains can learn

With monovision, one eye is the distance eye and the other is the reading eye. We can learn to automatically use just one eye, the appropriate one for what is being focused on. The ad

dd to the challenges in developing combination products:

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

ustment period is several weeks. Most people who have it done are pleased with the result. Now they can see near and far without any contacts or glasses. It’s a good idea to try monovision with conta

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

t lenses first, to see how well you can adjust to it, and many people do this. Disadvantages of monovision
· A slight loss of depth of perception
· A slight loss of peripheral vision
·

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

If you need to see extra clearly at certain times, such as for night driving or long sessions with reading or computer work, you might want some reading glasses for those occasions, but will not need

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

them for routine tasks

Advantages of monovision
· You’ll need no glasses or contact lenses most of the time, perhaps ever
· You can legally drive without any vision correction
· Th

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

Professional from academic institutions, pharmaceutical industries, health care indust

cost is lower than that of LASIK or other laser procedures
· It can be undone

If you have it done and decide you don’t like it, you can have it undone, and your “near” eye corrected for dis

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

tance. Then your 2 eyes will be working together again but you’ll need to wear reading glasses.

If you wear bifocals or reading glasses, you might like to consider the option of dispensing with them

.

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

nd instead, using your brain’s adaptive power to learn monovision. Some LASIK centers give little information about monovision. Some take time with you to explain how it works and answer your question

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

Companies that provide selfless information through particip

.

If you have it done and then change your mind about it, some will follow up with you and correct your near eye for distance vision at no charge, so that you can revert to using your reading glasses

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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