Advice Pool - Health and Fitness

Many patients do not realize that the eye is really an imperfect optical system. As light rays from distant objects pass through the individual optical components of the eye, they are s

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

ubjected to distortion by these imperfections which are found in the cornea and the eyes' crystalline lens.

These distortions create what are called “aberrations.” 90% of these aberrat

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

Examples of combination products may in

ons create common refractive errors such as farsightedness, astigmatism and nearsightedness which are usually treated by optical devices like contact lenses, laser eye surgery, using PR

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

, LASIK (or LASEK) or basic eyeglasses. But if these options don’t fully correct the problem, then you should get a customized corneal shaping because each of our eyes is unique. So you

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

can’t just go to your eye doctor in a snap and say,” I want the surgery this girl in front of me is taking,” because it’s simply not as easy as that.

Custom Lasik is done in the same w

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

Combination pro

ay as conventional Lasik surgery. However, the computer in the VISX laser is programmed with digital data from a special Wave Scan Device. Then, a personal treatment or correction is un

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

quely designed for just your eyes.

The other 10% optical aberrations create images that are distorted by chromatic aberration diffraction, spherical aberration, coma, curvature of fiel

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

, trefoils and quadrifoils, which are also known as “higher order aberrations.”

To achieve a customized corneal shaping, you will have to undergo wavefront analysis. This requires meas

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

rement of the higher optical aberrations using the Aberrometer, and interfacing it with the laser, digitally using a high speed computer to control directing the microscopic focus of a

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

tiny laser beam across the cornea.

Custom LASIK or Custom Lasik surgery also known as wavefront or wavefront-guided LASIK makes use of 3-dimensional measurements on exactly how your ey

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

processes images to guide the laser in re-shaping of the front part area, which is the cornea.

With the wavefront measurement system, some extremely accurate, individualized vision co

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

Following aspects would a

rection results may be achieved that is impossible from the traditional LASIK surgery, eyeglasses or with contact lenses.

Custom LASIK is the next step forward in Lasik technology. Bec

dd to the challenges in developing combination products:

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

use each person’s vision is unique, it is like a one of a kind fingerprint. Through Wave Scan Technology, unique imperfections can be captured in each individual’s vision that can not b

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

e measured by the current standard methods.

It is important to remember that Custom Wavefront Guided Lasik should not be confused with the Wavefront Optimized Laser Eye Surgery. To hav

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

a truly Custom LASIK procedure needs a measurement by the aberrometer, as mentioned above, and then the Excimer Laser is directly programmed using the gathered measurements. Those meas

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

rements will act as a ultra-detailed map for the Excimer Laser.

For some less complex eye conditions, Custom Wavefront Optimized LASIK will be sufficient. However, for the more complex

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

Professional from academic institutions, pharmaceutical industries, health care indust

eye problems, a true Custom Wavefront Guided Lasik will be the procedure of choice.

According to many research websites, the Custom Lasik's performance is very impressive. Most partici

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

pants (in a particular study concerning Custom LASIK) were very satisfied with their night vision after the procedure as compared to the night vision they had before even when using top

.

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

notch glasses or contact lenses.

To make Custom Lasik even more accurate, the so-called Custom Vue Laser now includes Iris Registration. This is just the latest advancement in the indu

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

Companies that provide selfless information through particip

try that allows the laser to account for any eye movements that may occur when laying flat on your back. This kind of innovation makes your tailor-made procedure even better then before

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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