E-Articles - Health and Fitness

First, what’s in common?
Wavefront LASIK (also called Custom LASIK), and traditional LASIK both:
· Use an excimer laser
· Create a tiny flap on the corneal surface to expose the underlyin

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

g tissue to be worked on
· Modify the shape of the cornea by vaporizing tiny pieces that were impairing your vision
· Are extremely precise
Advantages of Wavefront (Custom) LASIK It prov

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

Examples of combination products may in

des particularly precise information on how your vision is impaired. Custom LASIK measures each eye with a special laser, using wavefront technology, and creates a 3-D map of the eye. This is translated

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

by the Wavefront system into mathematical information that’s used to guide the laser in correcting the problems. Two types of vision problems

1. Lower order aberrations – nearsightedness, farsightedne

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

s and astigmatism. These are refractive errors and are correctable by traditional LASIK surgery.

2. Higher order aberrations (HOA)

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

Combination pro

– halos around lights, impaired night vision, starbursts etc. These are not refractive errors and not correctable by traditional LASIK, but can be measured and corrected by Wavefront LASIK. The HOAs 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

e sometimes created by traditional LASIK, and although there are still some who argue that Wavefront LASIK can also create them, most refractive surgeons agree that it’s much less likely to create them

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

than traditional LASIK. About 75% of refractive surgeons now use Custom LASIK. Amount vs. quality of vision Amount – A person with 20/20 vision is said to have perfect eyesight. That’s an assessment

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

f the person’s AMOUNT of vision, or how MUCH he sees. Impairment of our amount of vision is brought about by lower order aberrations. Quality – How WELL we see is determined by the presence or absense

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

f higher order aberrations. So if we have impaired contrast sensitivity and can’t see very well at night, or we have glare and halos around lights, these defects can be both measured and treated by Wave

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

ront LASIK. The Wavefront LASIK procedure
· The eye surgeon sends a light ray into your eye
· The light is reflected back off the retina (interior surface of the back of the eye, like the fil

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

Following aspects would a

in a camera) to the Wavefront system
· The system arranges this modified light into a pattern of all your vision aberrations, lower and higher
· It displays this pattern on its computer monit

dd to the challenges in developing combination products:

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

r as a 3-D map of each eye, the wavefront map
· When your eye surgeon applies the laser treatment to your eyes, he uses this same information to guide the laser.

Unique to you This all result

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

in a vision remedy that’s unique to you. Unlike glasses and contact lenses, which are remedies that come according to prescriptions that millions of other people also have, this treatment is entirely c

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

ustomized. That’s another way of saying that it’s extremely precise, so precise that nobody else would benefit from it. They’d all have their own 3-D maps. Pre-testing with traditional LASIK Before tr

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

ditional LASIK, there are also tests done to pinpoint the corneal problems. They’re done using a variety of devices which each give a different kind of information. For example:
· The photopter –

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou look through various pairs of lenses and tell the eye doctor which set gives you the best clarity
· The corneal topographer – collects reflected infra-red light from your eyes and creates a digi

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

al map of each eye
· Fluoracaine or some similar dye – stains the corneal surface so that your eye doctor can see more clearly where the irregularities are

These tests give a lot of informatio

.

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

, but not to the precise detail of the wavefront technology. They also take longer. Wavefront diagnostic

If you’re considering a LASIK procedure, whether LASEK, PRK, or Epi-Lasik, or traditional LASIK

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

Companies that provide selfless information through particip

you can have a wavefront diagnostic done first. This will indicate the severity of any HOAs you may have. This information in turn will guide your eye surgeon in recommending the best procedure for you

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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