Advice Pool - Health and Fitness

Eyelid and eye surgery are becoming an ever more popular solution to correct vision. Eyelid surgery is common to correct drooping eye

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

lids and reduce bags under the eyes. Eye surgery, LASIK in particular, is more popular than ever as patients look for easier ways to

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

Examples of combination products may in

orrect vision. Each surgery has different requirements for an ideal candidate.

Eyelid Surgery: The Ideal Candidate

Eyelid surgery c

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

an help repair drooping eyelids and bags beneath the eyes. The procedure will not fix sagging eyebrows or crow’s feet. Make sure you

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

now exactly what look you are going for when you explain your desires to the doctor.

Age Requirement

Although there are no age requ

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

Combination pro

rements for eyelid surgery most patients are over the age of 35. Some younger patients may decide to have the procedure if drooping e

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

yelids run in the family. If your child is considering this surgery, remember to carefully consult with the doctor before making any

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

romises to your child.

Medical Requirements

You must be in good health to have eyelid surgery. Certain conditions can make this pro

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

edure especially risky. If you have a thyroid disorder, high blood pressure, diabetes, dry eye, or cardiovascular disease, you may no

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

t be able to have the procedure. Please be sure to give all your medical information to your doctor when you go to the office for you

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

consult.

Eye and LASIK Surgery: The Ideal Candidate

While eye and LASIK surgery can certainly improve vision, eye procedures are n

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

Following aspects would a

t for everyone. There are several requirements to be an ideal candidate for LASIK.

Age

To be an ideal candidate for LASIK, you shou

dd to the challenges in developing combination products:

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

ld be over the age of eighteen. Until that age, a young person’s body, and in particular their vision, changes continually. Most doct

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

rs will actually refuse to perform this procedure on a person under eighteen.

Vision

Additionally, your prescription should not hav

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

changed significantly for at least the past twelve months. Before approving the surgery, your doctor will perform a complete eye exa

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

m and prepare it to your previous exam.

If you have not had a recent exam, your doctor may ask you to wait for a year to make sure t

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

Professional from academic institutions, pharmaceutical industries, health care indust

at your prescription doesn’t change. Should your prescription change after the surgery, you could suffer from some complications and

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

ave to have another procedure or return to wearing glasses and contacts.

Other Considerations

If you have certain medical condition

.

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

s or are on some types of prescriptions, you may not be an ideal candidate for eye surgery. You need to give your doctor your full me

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

Companies that provide selfless information through particip

ical history so that he or she can make the right call before scheduling a surgery. Pregnant women should also not have LASIK surgery

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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