Advice Pool - Health and Fitness

Many eye surgeons use the wavefront-guided VISX system, which is known as CustomVue. The Iris registration is a hardware upgrade installed on this system.

Wavefront-guided L

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

ASIK It’s also called Custom LASIK, for good reason.

In the diagnostic stage the wavefront system takes many measurements of each cornea in tiny detail. From these, it mak

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

Examples of combination products may in

es 3_D maps, which it displays on the system’s computer monitor. The information contained in these maps is used to calibrate the laser for treatment.

Nobody else in the world

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

has eyes exactly like yours. These maps are created in such tiny detail that they can’t be mistaken for anybody else’s, and the laser treatment based on them will be unique to y

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

ou. It’s an entirely customized treatment.

A small Achilles’ heel in Custom LASIK In between the time the eyes are diagnosed and mapped by d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

/www.khannainstitute.com/custom_lasik.html">Wavefront-guided LASIK, and the time of treatment, if the eyes change at all, the laser needs to be adjusted to match.

Eye movem

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

ents
When you lie down for your treatment on the patient bed that’s part of the wavefront unit, you’re moving your eyes from a vertical to a horizontal orientation, and in

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

that change, sometimes the eyes rotate, which is called cyclotorsional movement.

The eyes could make other movements too, in between the mapping stage and the treatment:

The s

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

ize of the pupil can change if the ambient lighting changes

The head may turn slightly to one side That means that the measurements done on your eyes while you were sitting wi

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

ll be very slightly wrong now that you’re lying down for treatment. The wavefront diagnostic information needs to be slightly modified to align the laser to the eyes’ new positi

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

ons.

Previous ways of aligning treatment Your eye surgeon needs a reference point for aligning the laser during treatment. In the past there have been two ways of setti

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

Following aspects would a

ng the reference point: 1. Manual – with a sterile pen, the eye surgeon made tiny marks on the cornea to indicate where the laser would be focused during treatment. At the time

dd to the challenges in developing combination products:

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

of treatment, he manually positioned the patient’s head so as to line the laser up with the marks. This method was prone to human error at times. Also, the ink used to make th

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

e marks was short-lived, drying up after a minute or so. 2. Semi-automatic – The outlines of both the pupil and the iris were used as reference points and with the eyes dilated

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

to enlarge the pupil, tiny marks were manually made outside the iris to indicate where treatment should be focused. This method took longer, as the eyes had to be dilated, an

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

d it also allowed human error to creep in at times.

Automatic iris registration
The outside boundary of the iris does not change, only the inside boundary when the pupil c

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

Professional from academic institutions, pharmaceutical industries, health care indust

hanges size. So iris registration uses the center of the pupil as the reference point, targeting the laser beam on that center, as it relates to the outside of the iris.

During

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

treatment, the Wavefront software works with two images of your eye:

The pre-operative image contained in the 3-D map

The present-time image as you’re receiving treatment

If

.

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

there’s any movement during treatment, it automatically and continuously re-matches the two images to each other, causing the laser to re-target on the prescribed treatment are

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

Companies that provide selfless information through particip

a.

Because of this continual automatic readjustment of the laser, your eye surgeon can treat exactly those areas which his or her diagnostic tests revealed as needing treatment

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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