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If you have keratoconus, you can skip the next paragraph and move right down to the lens styles available that can improve your life. Because if you have any form of kera

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

toconus you already know how it affects your vision and life. You know that eyeglasses do not work; you know that your corneas are constantly dry and sensitive, and you k

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

Examples of combination products may in

now that without contact lenses, you would not be able to see.

For those of you that do not have or know what it is; Keratoconus is a degenerative disease of the cornea

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

that leaves the front of the eye cone-like in shape. As far as vision is concerned, eyeglasses do not work. Contact lenses are the best and, in many cases, the only optio

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

n for functional eyesight.

The challenge usually lies within balancing comfort, vision, and ocular health. Fitting a keratoconic cornea with contact lenses requires skil

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

Combination pro

l, experience, and patience. Recently the first ever global keratoconus symposium was held. Contact lens specialists from around the world gathered to discuss techniques,

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

lenses, and study findings in regards to fitting keratoconus patients with lenses. Everybody left this meeting with a ton of new insight and ideas, yet the bottom line r

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

emains; There are no rules when it comes to fitting irregular corneas. It takes a qualified specialist and good toolbox of contact lens designs.

Five of the latest conta

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

ct lens designs that may improve the health, vision, and comfort of any keratoconus patient:

Synergeyes KC - This lens is the latest breakthrou

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

gh in hybrid technology. The center of the lens is a high oxygen permeable rigid material, while the outer skirt is a soft lens. The KC design merges the optics of a gas

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

permeable lens with the comfort of a soft contact.

Rose K2 IC - Rose K has long been the most widely used keratoconus GP design. This new versio

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

Following aspects would a

n is available in larger diameters for improved comfort. The IC refers to irregular cornea.

Wave Custom Contacts - Wave contact lenses are indiv

dd to the challenges in developing combination products:

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

idually designed lenses based on topography readings. It takes a real computer geek/contact lens specialist to fit these, however the results can be phenomenal.

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

Semi Scleral Lenses - Large diameter gas permeable contact lenses that rest out on the white of the eye. What is surprising to many is that these lenses

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

are incredibly comfortable. The reason soft lenses are comfortable is not because they are soft, it is because they are larger and move less. They are simply easier to fi

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

t because of the loose modulus. A large diameter GP lens can be an incredibly comfortable route to go.

Piggy Back Contact Lens System
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
trong> - Wearing two lenses on one eye is more pleasant than it may sound. With the available materials we have today in both soft and GP lenses, piggy back systems are i
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ncredibly healthy and comfortable. The soft lens actually protects the sensative cornea.

Keratoconus patients, if you are looking for an update, it is a great

.

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

time to revisit your contact lens specialist. Keep in mind all the designs listed below will not work on every type of cone, but as you can see a qualified fitter will ha

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

Companies that provide selfless information through particip

ve enough lenses in their toolbox to handle just about any lens fitting.

And for those of you that do not have keratoconus, just imagine the lens designs we have for you

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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E-Articles - 5 Revolutionary Contact Lens Designs For Keratoconus

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