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Did you know that there are several kinds of eye surgeries which improve vision? These types of surgeries on the eyes are called refractive surgery.

The most popular of these ey

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

e surgeries is LASIK, but is not the only one by any means. Before you consult with an eye care expert, you need to know your options. Keep in mind that both eyes are not done at

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

Examples of combination products may in

once. You will have to have one eye corrected and, after it is healed and focusing, you can look into having your other eye corrected. Eye surgery options which you may want to 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.

onsider are:

Excimer Laser Procedures are eye surgeries which utilize lasers in reshaping the cornea. This reshaping changes the way that light enters the eye and helps correct

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

ocus. The following procedures are Excimer Laser Procedures:

Laser Epithelial Keratomileusis, commonly referred to as LASEK (not to be confused with LASIK, which is different),

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

Combination pro

an be used to treat astigmatism, farsightedness, or nearsightedness. This eye surgery is used if you have flattened or thinned corneas. People who will not get optimal results fr

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

om LASIK eye surgery are often excellent candidates for LASEK eye surgery. However, it does take a little longer to heal from LASEK eye surgery.

Epi-LASIK eye surgery is done by

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

an eye care professional and is much like LASEK eye surgery. In this eye care procedure, no blade or alcohol is used. Less pain seems to be experienced along with more rapid heal

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

ng that LASEK eye surgery.

Laser Assisted In Situ Keratomileusis, commonly known as LASIK eye surgery, is also used to treat astigmatism, farsightedness, and nearsightedness. La

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

sers are used to reshape your eye in this eye surgery; scalpels and alcohol are used but the surgery is very quick, less than a minute per eye as a general rule.

All Laser LASIK

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

is a LASIK surgery that does not use a scalpel. Like traditional LASIK eye surgery, lasers are used to reshape the eye. Both discomfort and healing time are reduced because surge

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

Following aspects would a

y only utilizes lasers.

Photorefractive Keratectomy, commonly known as PRK, is used to treat astigmatism, nearsightedness, and mild farsightedness. In this eye surgery, surface

dd to the challenges in developing combination products:

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

tissue is removed from the cornea (reshaping the eye) using a laser. Like LASIK eye surgery, this surgery takes less than a minute per eye as a general rule.

Non-Excimer Laser P

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

ocedures are surgeries in which new lenses are actually places in the eye. The eye is then reshaped using radio waves, lasers, or scalpels. The main Non Eximer Laser Procedure is

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

Astigmic Keratotomy, otherwise known as Limbal Relaxing Incisions. This eye surgery is used to help correct mild astigmatism. Scalpels are used to reshape the eye and the surgery

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

is often used as an enhancement to another eye surgery.

If you are considering eye surgery, you need to know all of your options. This list is a general learning tool but it is

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

Professional from academic institutions, pharmaceutical industries, health care indust

recommended that you do further research on any surgery you are interested in or your eye care professional suggests. Keep in mind that each surgery is much like the others, but

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

hey are all different as well.

While on surgery may be fine for some peoples lifestyle, it may not be fine for yours. For instance, as a general rule, the older surgeries fit bu

.

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

dgets better, but have longer healing times. You need to consider all aspects of eye surgery and how they will impact your life. When figuring healing times into the equation, it

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

Companies that provide selfless information through particip

is best to plan on the longest healing time named for that surgery. Faster healing is just a bonus, while extended time could cause problems with other life events (such as work)

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 - Did You Know That You Have Options in Surgical Eye Care Procedures?

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