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PRK sculpts the eye from the outside, removing the epithelial layer entirely, risking corneal haze and requiring a longer recovery time and longer

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

time to achieve full vision benefits than LASIK. Corneal haze often occurs as an immune response, because the eye interprets the surgery as traum

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

Examples of combination products may in

.

In LASIK a flap is created that allows all the work to be done inside of the eye and produces almost immediate results. The eye does not interp

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

et LASIK surgery as trauma, so corneal haze does not occur. LASIK can result in flap complications and, because the nerves which trigger tearing a

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

re cut, it can cause dry eye. It is not appropriate for patients with thin or steep corneas, or patients who engage in activities which could caus

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

Combination pro

the flap to dislodge, such as contact sports.

LASEK uses a very fine blade and an alcohol solution to lift the epithelium, so the work is done i

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

side of the eye, like in LASIK, but a flap is not created. The nerves which cause tearing are not affected, so the risk of dry eye is not elevated

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

.

The Procedure

You will be awake. Anesthetic drops are used to numb your eye. During the LASEK procedure a very fine blade, called a trephine,

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

s used to cut the epithelium. Your eye is soaked in an alcohol solution for about 30 seconds to make it easier to lift. The solution is sponged of

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

and the epithelium is gently lifted and folded back out of the way. The cornea is sculpted with an excimer laser, and the epithelium is carefully

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

put back in place. You will wear a bandage contact lens for several days.

Achieving the full visual benefits of LASEK usually takes about four to

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

Following aspects would a

seven days. This is much quicker than PRK which can take up to six months, but not as quick as LASIK which can produce almost instant results.

E

dd to the challenges in developing combination products:

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

ithelium loss
In some rare cases the epithelium is too weak to be replaced. When this occurs the PRK procedure is chosen. For most patients t

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

is does not cause long-term problems, but it does mean a longer wait for full visual benefits. Patients who choose LASEK because they are not good

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

candidates for PRK may experience more serious complications, particularly corneal haze.

LASEK candidates
Good candidates for LASEK are tho

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

e who meet the general criteria for any type of refractive surgery, but are not good candidates for LASIK or PRK for one or more reasons including

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

Professional from academic institutions, pharmaceutical industries, health care indust

· Large pupils
· Thin corneas
· Steep corneas
· Career or lifestyle which involves trauma to the head and face (contact sports, p

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

olice, military, etc.)
· Dry eyes
· Certain disorders of the corneal surface
· Myopia too severe for safe PRK

LASEK is a relativel

.

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

new procedure which combines old and new techniques. Risks associated with both PRK and LASIK are significantly reduced or eliminated altogether.

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

Companies that provide selfless information through particip

Some of the benefits of LASIK are reduced or lost. LASEK makes refractive surgery a safe option for many who are not eligible for other procedures

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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