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Inside the eye, just behind the pupil is a lens. Like a lens inside a camera. This natural lens of the eye has the shape of a tiny discus. In youth this lens is very pliable and there is a muscle wi

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

thin the eye which makes the lens change shape. As the lens changes shape the focus of the eye is adjusted. This is why young children can see clearly in the distance but can also read within inches

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

Examples of combination products may in

or their nose. This ability to adjust the focus of the eye from distance to near vision is called “accommodation”.

Unfortunately as we get older the lens becomes stiffer little by little. This is

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

very predicable and unavoidable. Gradually the focus adjustment power of the eye declines. The nearest point that can be seen clearly moves further away. If the eye is neither long or short sighted,

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

reading at a normal distance usually becomes difficult from mid forties onwards; especially if one attempts to read small print, in poor light, when tired. From then on reading spectacles are neede

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

Combination pro

d.

This will happen at an earlier age if the eye is “long sighted”. This is because in this condition the eye is optically under powered for distance vision. To overcome this some of the focusing r

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

eserve of the eye must be used just to maintain clear distance vision. There is then less focusing reserve for near vision.

The process (called “loss of accommodation”) continues so that by mid 60’

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

s the lens is so stiff that it cannot change shape at all. The eye has become fixed focus. This loss of the ability to focus and see clearly for near vision is called “presbyopia”.

Science has not

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

yet come up with a way of truly restoring the natural focus adjustment ability to the aged eye. Solving this problem is at the frontier of current research.

Nevertheless there are several ways in w

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

hich this middle age loss of near vision can be helped, and dependence on reading spectacles reduced. If both eyes have good vision then the focus of one can be set for distance whilst the other is

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

et for near vision. This concept is called “monovision” or “blended vision”. It is a compromise. A deliberate difference is created between the eyes. Some people adapt to this and others never do. T

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

Following aspects would a

o work well it requires the brain to ignore, or be unaware of, the eye that is out of focus. As gaze changes from distance to near (and vice versa) the brain should switch from attending with one ey

dd to the challenges in developing combination products:

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

e to the other so that whatever is being looked at is seen in focus with the appropriate eye; whilst the blur from the fellow eye is not noticed. The standard of near vision is rarely as good as wit

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

h spectacles, as with specs’ both eyes are in focus together, whereas with monovision only one eye is providing focused near vision. Some patients are bothered by the compromised distance vision in

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

the near sighted eye, e.g. when driving at night.

Monovision can be achieved with contact lenses and various forms of eye surgery; e.g. laser refractive surgery (LASIK, LASEK, Epi-LASIK), Conductiv

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

e Keratoplasty (CK), or through Refractive Lens Exchange. Which form of surgery is most appropriate will depend on the initial focus state of the eyes. If both eyes have perfect distance vision (lit

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

Professional from academic institutions, pharmaceutical industries, health care indust

tle or no refractive error) then CK to the non dominant eye may be best. However if there is a large initial error in both eyes, too great to fix with laser surgery, then Refractive Lens Exchange is

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

perhaps a better option.

Refractive Lens Exchange involves surgery very similar to a cataract operation. The natural lens is removed from the eye and replaced with an artificial lens; called the “

.

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

lens implant”. The power of the lens implant is chosen to give the eye the focus required.

In an attempt to provide a single eye with both distance and near vision a multifocal implant may be used.

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

Companies that provide selfless information through particip

However these do reduce the quality of vision somewhat. Lens implants that provide some focus adjustment for near vision do exist but this is far short of that naturally present in the youthful eye

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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An arraignment is the first appearance in court or before a judge on a criminal charge. Generally, the accused is expected to enter a plea in response to arraignments. Any failure to attend arraignments can lead to more criminal charges, fines, and sometimes even to an immediate arrest warrant.

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