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Contact lenses have advanced repeatedly over the years, so the variety we can choose from is enormous. But:
· They still need to be replaced at certain intervals
· They can still be lost
· They must

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

still be cared for
· There’s still an adjustment period when you first start wearing them
· Some people can’t wear them at all
LASIK surgery is permanent A LASIK procedure alters the shape of your

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

Examples of combination products may in

cornea such that your vision is improved. It’s an effective surgery for treating:
· Nearsightedness (myopia)
· Farsightedness (hyperopia)
· Astigmatism (irregularities on the corneal surface)

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

hese 3 visual problems are all caused by the shape of the cornea. Visual problems such as cataracts and presbyopia, which are caused by lens problems, can’t be treated with LASIK. Are you a LASIK candidate?

The

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

first thing to do is have a thorough eye exam. All good LASIK surgeons will do this to establish whether or not you’re a good candidate, because good outcomes are important to a good LASIK surgeon. A good outcome

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

Combination pro

isn’t possible with a bad candidate.

If your corneas are too thin, your pupil diameters too large, or the cause of your vision problem is other than a refraction issue, you won’t be a good candidate for LASIK. An

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

if you’re:
· Under 18
· Diabetic
· Pregnant
· Have any of a variety of certain diseases
· Are taking certain medications
you will not be a good candidate.

Wavefront Diagnostic

Trad

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

itional LASIK surgery requires pre-testing which uses a number of sophisticated devices to precisely measure your corneas and assess your vision. A newer variety of LASIK called Wavefront-guided LASIK uses wavefr

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

ont technology to even more precisely diagnose the cause of your vision impairment. A special light is beamed into your eyes from the wavefront system. It bounces back from the retina (inside back surface of the e

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

es, like a camera film) to the wavefront system, carrying with it detailed information about the irregularities of your corneas.

This information is presented on the wavefront computer monitor as a pair of 3-D ma

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

ps of your eyes. Each tiny ripple or bump on your corneas is clearly visible now to your eye surgeon. From this information, mathematical formulae are created which then guide the laser in correcting the problem.

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

Following aspects would a

Wavefront diagnostic can be done on anyone’s eyes. It’s independent of whatever solution is chosen for you to correct the problem. Many LASIK surgeons use wavefront technology and offer a wavefront-guided LASIK

dd to the challenges in developing combination products:

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

rocedure as well as the traditional procedure.

The LASIK procedure It’s a short and painless procedure yielding quick results and a short recovery period.
· Anesthetic eyedrops numb your eyes.
· Your c

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

omfortable bed is rotated to position your head beneath the laser. You don’t need to struggle with keeping your eyes open, as an eye speculum is placed against your eyelids to keep them open.
· One eye is tre

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

ated at a time, with a shield over the other one.
· Using a hand-held device called a microkeratome and a small suction cup, your eye surgeon will make a small round flap on the outer surface of the cornea,

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

nd gently fold it back out of the way.
· The laser is directed at the tissue exposed by the folded-back flap, for 10 to 20 seconds. It vaporizes tiny amounts of excess corneal tissue that have been causing yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

ur vision problem.
· The surgeon replaces the small flap and applies some antibiotic ointment to its edges. It starts to heal by itself, and no stitches or bandages are needed.

Afterwards Although there

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

’ll be some temporary blurriness from the antibiotic ointment, you’ll notice immediate improvement in your vision.
· An eye shield needs to be worn for a day or so to protect your eyes from touching or pressu

.

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

e
· Your LASIK surgeon will give you some moisturizing eyedrops and antibiotic eyedrops to use for a few days
· There might be some temporary redness or sensitivity to light, but no pain or swelling Wit

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

Companies that provide selfless information through particip

hin a month or so you’ll be completely healed and your new eyesight will be part of your life. Wouldn’t you like to toss away the contact lenses and be able to see clearly at all distances with your natural eyes

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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