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The American Eye Surgery Education Council, a professional society of ophthalmologists,

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

has developed a list of medically accepted criteria to determine the ideal, less-than-

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

Examples of combination products may in

ideal and unsuitable candidates for laser eye surgery. Here is a chart to help you und

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

erstand if laser eye surgery is right for you: Profile Characteristics

Ideal candidat

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

e Is at least 18 years old
Is afflicted by one of the refractive errors (myopia,

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

Combination pro

hyperobia, astigmatism or a combination). The ideal candidate has myopia up to -12 D, a

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

stigmatism up to 6 D and hyperopia up to +6 D

Has worn glasses or contacts for at leas

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

t two years
In the case of Lasik, has a sufficiently thick cornea for the surgeon

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

to cut a flap Does not suffer from any disease or health condition which would preve

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

nt or significantly slow the healing process or complicate surgery
Is adequately

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

informed about the risks of laser eye surgery.

Less-than-ideal candidate Has dry eyes

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

Following aspects would a

(a condition which can worsen after surgery) Has a suppressed immune system, which ca

dd to the challenges in developing combination products:

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

n affect healing
Is under the age of 18
Is pregnant or nursing
Has re

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

cently had a change in vision, ie a change in your contact/glasses prescription
H

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

ave refractive errors that are too severe to be entirely treated with current technolog

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

y

Unsuitable candidate Has cataracts, advanced glaucoma or other corneal diseases whic

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

Professional from academic institutions, pharmaceutical industries, health care indust

h preclude laser eye surgery
Does not give informed consent
Has unrealistic

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

expectations

Something else to consider: Would your career be jeopardized if your sur

.

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

gery weren't to result as expected? Certain careers, such as some of those in the milit

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

Companies that provide selfless information through particip

ary, prohibit or restrict refractive eye surgery. Check with your employer to make sure

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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