Your Space - Health and Fitness

Contact lenses are the rage these days with more and more wearers discovering the comfort and ease of wearing contact le

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

nses. It also enhances the looks of a person as contact lenses are worn on the eyes and can be a fine substitute for a p

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

Examples of combination products may in

ir of spectacles. Thus one can see one’s face without the hindrance of spectacles over the bridge of the nose that shade

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

away the beautiful eyes.

What then are contact lenses? One might wonder. A contact lens is actually a thin piece of pl

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

stic or glass that is fitted over the cornea of the eye. Thus it can eliminate the need for spectacles as defects in one

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

Combination pro

s vision can be set right merely by wearing these thin pieces of glass or plastic over the cornea of the eye. Thus conta

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

t lenses can be worn easily by people with vision defects like myopia. Hyperopia, astigmatism, and other related problem

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.

These corrective measures to be worn over the cornea of the eye come in two different types. Contact lenses come wit

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

hard or soft lenses. They are defined as soft lenses as these contact lenses are made of soft plastic and are much pref

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

rred by the today’ wearer. They are very comfortable to wear, as they can hold water. Most times soft lenses are disposa

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

le lenses as well. Thus the busy wearer of today, who cannot be strapped to a routine of regular lens cleaning in additi

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

Following aspects would a

n to his or her other responsibilities, is rightly suited for wearing soft lenses.

The contact lenses that are made wit

dd to the challenges in developing combination products:

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

a glass piece are usually the hard lens variety. These lenses are rigid and gas permeable. Some of these hard lenses ma

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

even have a colored tint so that locating these lenses for the wearer becomes easier.

They are also fitted with UV pro

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

tection in most cases and can be fitted with bifocal lenses as well. The wearer of such a lens is blessed with durabilit

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

though cleaning these lenses has to be a regular routine.

As these lenses are now made with silicone polymers, they al

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

Professional from academic institutions, pharmaceutical industries, health care indust

ow oxygen to circulate freely to the cornea. They are meant for regular wear, but extended wear over the night is not re

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

ommended. Constant wear can limit the flow of oxygen to the cornea and in some cases can even lead to damage of vision.

.

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

By and large, with a little precaution, one can find the contact lens that is ideally suited for one’s lifestyle and go

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

Companies that provide selfless information through particip

bout one’s work unhindered by the hassle of having to carry a pair of glasses as one of the essential items in one’s bag

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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