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Sometimes in the months and years following a cataract operation the vision within the eye can gradually diminish. For the patient the effect can be rather like

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

the original cataract recurring. One common cause for this is a phenomena called “Posterior Capsule Opacity”. It is also sometimes referred to as “after catarac

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

Examples of combination products may in

”. What is it?

This can be explained by thinking of the eye as a camera. Like a camera the eye contains a lens. This is positioned within the eye just behind th

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

e pupil. This natural lens of the eye has the shape of a tiny discus, similar in size to a “smartie” or “M & M” sweet. A cataract occurs when this lens becomes h

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

zy and obscures vision. To remove a cataract the surgeon must therefore remove the lens from the eye.

The lens of the eye has a thin membranous outer layer. Thi

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

Combination pro

is called the lens capsule. As with a discus there are two main surfaces to the lens capsule. The front surface is called the anterior capsule and the rear surf

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

ace the posterior capsule. During modern cataract surgery a small piece of the anterior capsule is removed in order to gain access to the cloudy interior of the

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

lens. The art of cataract surgery is to remove this cloudy inner lens material whilst preserving the posterior capsule that lies behind it.

Returning to the “sm

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

artie” or “M & M” analogy a cataract operation is a bit like removing a tiny piece of the sugar coating from one surface so as to remove the chocolate within; bu

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

leaving behind the rest of the sugar coating intact! The effect is to create a little empty sac with a hole in its front surface. In the eye this is called the

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

apsular bag. A replacement artificial lens (called the lens implant) is then inserted into this bag. The posterior capsule lies behind this lens implant and part

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

Following aspects would a

ially supports it.

The posterior capsule is extremely thin and delicate. Its centre is thinner than a single red blood cell! Eye surgeons make every effort to

dd to the challenges in developing combination products:

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

reserve the posterior capsule intact during surgery. It helps maintain the natural compartments within the eye. It separates the fluid filled space at the front

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

of the eye from the jelly (called the vitreous) that fills the main rear cavity of the eye. It also stops the vitreous from moving forwards and interfering with

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

he operation.

At the end of surgery the posterior capsule is clear and transparent. In some patients it may become hazy or opaque during the following months an

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

years. This is "Posterior Capsular Opacity". Eye surgeons refer to it as “PCO”. If this happens and it impairs vision significantly it can be treated using a la

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

Professional from academic institutions, pharmaceutical industries, health care indust

ser. This is a quick simple painless outpatient procedure taking just a few minutes to perform. This treatment is called a "YAG laser posterior capsulotomy". The

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

aim is to create a small opening at the centre of the posterior capsule and thus clear the line of vision. If there is nothing else wrong with the eye this treat

.

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

ment should restore vision to that first achieved after the original cataract operation.

The information within this article is for general interest only. These

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

Companies that provide selfless information through particip

are the personal views of Consultant Ophthalmologist Mr C J Heaven. If you have a problem with your vision then always seek the advice of your own eye specialist

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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