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If you're like me, you've probably heard about some of the side effects associated with getting lasik vision correction surgery. For instance, after getting lasik su

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

rgery some people complain about symptoms of glare, halos and decreased night vision.

In fact, I remember attending a business briefing where the speaker started by

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

Examples of combination products may in

mentioning he just had lasik surgery the day before. He told the audience, "The good news is I think you're all going to heaven because everyone has halos around th

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

ir heads!"

If you've considered getting lasik surgery but were concerned about some of the less-than-desirable side effects, you'll be glad to hear that new technol

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

ogy is reducing those dreaded halos and glare. Known as "custom" or wavefront-guided lasik, this relatively recent improvement in eye surgery technology produces bet

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

Combination pro

er vision quality when compared to traditional lasik vision surgery.

"Most significant," says US Navy Captain Steve Schallhorn, MD, the Director of Cornea and Refra

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

ctive Surgery at the Navy Medical Center, San Diego, "is the improved quality of vision with the wavefront-guided procedure, fewer problems with halos and glare, bet

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

ter night vision, and higher patient satisfaction."

Traditional lasik reshapes the patient's cornea with a laser to correct visual problems like nearsightedness or

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

arsightedness. With conventional lasik, the laser is guided based on formulas similar to the ones used to determine your eyeglass prescription. Conventional lasik is

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

effective at treating "lower-order" aberrations like nearsightedness, farsightedness and astigmatism (also called "refractive errors").

Wavefront-guided lasik, on

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

he other hand, measures how light is distorted as it passes into the eye and then is reflected back. This creates a 3-D optical map of the eye, highlighting the impe

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

Following aspects would a

rfections and disorders that lead to visual errors. Wavefront technology then creates a custom treatment plan for each eye and guides the laser during the surgery.

dd to the challenges in developing combination products:

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

Wavefront-guided lasik can effectively treat the same lower-order aberrations that conventional lasik can treat as well as treating "higher-order" aberrations such a

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

decreased contrast sensitivity, night vision, glare, shadows and halos. In fact, there are a growing number of patients turning to wavefront-guided lasik to correct

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

side effects from previous laser eye surgeries.

"With this technology breakthrough, we can now measure these disorders, show the patient what's going on in their e

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, link that information to the laser, and actually correct higher-order aberrations," says Roger Steinert, M.D., associate clinical professor of ophthalmology, Harv

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

Professional from academic institutions, pharmaceutical industries, health care indust

ard Medical School. "Wavefront technology enables the surgeon to improve overall vision quality better than in the past."

Of course, this advanced technology comes

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

with a higher price tag than traditional lasik surgery. And just like conventional lasik, wavefront-guided lasik is a surgical procedure and has risks associated wit

.

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

it. Be sure to consult with a qualified lasik surgeon to discuss potential complications and ensure you're a good candidate for this type of surgery.

But if the ch

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

Companies that provide selfless information through particip

oice is between crystal clear vision with no side effects and going through life seeing all the people going to heaven, I think I'll go with the first option, please

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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