E-Articles - Health and Fitness

The ReSTOR lens can be used by people seeking treatment for:

Cataracts

Presbyopia

It’s also available for anyone who has neither of these conditions, but who would like to gain more freedom from wearing glasses or contact lenses

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

. This is an off-label use, meaning it’s not (yet) approved by the FDA, but is legal and appropriate in the right circumstances.

Cataracts

There are 3 types of cataracts, classified according to how they form and develop. But all

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

Examples of combination products may in

are slow-growing areas of opaqueness in the lens of our eye.

The light rays coming to our eyes can’t pass freely through these opaque areas, but instead are scattered. So vision becomes blurry and we notice extra brightness near l

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

ght sources.

Cataract surgery

In this procedure, eye surgeons remove the natural lens and replace it with an intraocular lens (IOL) made of a clear plastic. It’s usually focused for distance vision. So it restores our full visual

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

acuity for distance vision and we must still wear reading glasses.

Presbyopia

When we reach the age of 40 or so, most of us notice reduced near-distance vision. We need glasses for reading. This sometimes seems to be hyperopia (f

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

Combination pro

rsightedness), because we can often see quite well in the distance, but not close up.

But presbyopia has a different cause than hyperopia. It’s not caused by the shape of our corneas, but by a combination of two age-associated ten

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

dencies:

1. The lens is becoming more stiff, so it doesn’t change its shape so easily to allow us to focus at all distances

2. The tiny muscles that control the lens’ shape are becoming weaker.

The result is diminishing near-dis

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

ance vision. Eventually far-distance vision is affected also. The main treatment for presbyopia so far has been monovision, where one eye is corrected for distance vision and the other for near vision. The brain learns to see this

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

way after a month or two, and it works well for some people. But this treatment is not for everyone. What is the ReSTOR lens?

The ReSTOR lens is a type of IOL

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

which can replace the natural lens and improve both near- and far-distance vision. It’s like a bi-focal lens. Unlike our natural lens, it doesn’t work in conjunction with our eye muscles, and change its shape when we focus at diffe

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

ent distances.

It’s designed with a series of steps which are larger in the center of the lens and become progressively smaller towards the edges (known as apodization). This causes progressively less energy to be directed to clos

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

Following aspects would a

e-up focus. It distributes light according to how wide or small the eye's pupil is, and regardless of the light in the environment.

It’s designed in two parts.

One part is an apodized diffractive lens, used for near distances

Th

dd to the challenges in developing combination products:

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

other is a refractive lens used for far distances

In between is an area for mid-range distance. So it enables you to see at all distances without glasses or contact lenses. Results are better if both eyes have a ReSTOR lens, and

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

here’s usually a wait in between the two surgeries of about a month.

Who is a candidate?

There are no known medical contraindications.

If you have cataract surgery, it’s definitely a good choice of IOL to replace your natural le

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

s.

If you have presbyopia, it’s a good option, whether or not you have cataracts.

If you have neither cataracts nor presbyopia, you could be a candidate as long as:

· You don’t drive at night for a living

· Are not an airline p

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

lot or amateur pilot

· Have not had a lifelong problem with glare or halos

· You’d like to toss the reading glasses

Potential risks

Lens implant surgery is one of the most commonly done surgeries in the U.S.

The main risk woul

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

Professional from academic institutions, pharmaceutical industries, health care indust

d be infection, but it’s very unlikely if you follow your surgeon’s directions for the recovery period. Antibiotic eye drops are given both pre-op and post-op to guard against infection.

Some patients notice some glare and halo in

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

dim lighting conditions.

Procedure is not reversible

After your natural lens has been removed, it can’t be replaced. But why would you want it back, since it contained a growing cataract that was progressively diminishing your vi

.

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

ion?

If necessary, the ReSTOR lens can be removed and replaced with another lens. In the FDA clinical trials, no patient asked for this, as they were all very pleased with their new vision.

To learn whether you’d be a good candid

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

Companies that provide selfless information through particip

te for a ReSTOR lens, contact a good eye surgeon, one who’ll give you plenty of time to ask questions and understand the answers, who will do the surgery himself, rather than delegating it, and who will follow-up closely afterwards

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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