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PRK or Photorefractive Keratectomy is one of the types of laser eye surgeries that is very popular today. Like other laser eye surgeries, here, too, the cornea of the eye is res

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

haped and the success rate of this surgery is said to be very effective. In fact, it has been known to restore 20/20 vision or sometimes even better! Results have proved that 80

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

Examples of combination products may in

% of those who opt for this surgery can throw away their glasses or corrective lenses. And that for most people who have vision that needs correcting, is very good news indeed!

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

How is PRK laser eye surgery different from LASIK and LASEK? The difference lies in the fact that here, what the laser does is pulse the top of the cornea so there is no need t

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

o cut a flap in the cornea as the other laser surgeries do. So let’s look at all the benefits that PRK laser surgery offers. In the first place, if you want to go in for PRK, yo

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

Combination pro

ur case should be a moderate one of nearsightedness, farsightedness or astigmatism. Then you can be almost sure of benefiting from this surgery. As it does not entail slicing th

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 cornea and making a hinged flap in it, there is less likelihood of complications during and after the surgery. Cutting a flap sometimes hinders the healing process, especially

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

if the patient accidentally rubs his eye before it is fully healed.

Does PRK laser surgery have any disadvantages? Well, one of the complaints is that there is more pain after

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

the surgery. This could also mean discomfort for many days, as well as the eye watering and getting irritated for a much longer time. Further, in order to regain a 20/20 vision,

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

it might take several months and though the results are usually good, there is no guarantee that you will not have to use glasses after the surgery. People have also complained

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

about experiencing glare and seeing halos around images. The cost of PRK laser surgery is around $2000 for each eye, which is pretty much the same as for LASIK surgery.

Let’s

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

Following aspects would a

take a look at what PRK laser surgery involves. First of all the surgeon will have to do a complete medical history before the procedure can be fixed up. He has to satisfy himse

dd to the challenges in developing combination products:

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

lf that you are a good candidate for the surgery. So this would involve a bit of eye testing. After this, a date is set. This is what happens at the surgery. The patient is give

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

n a local anesthetic and then cool laser beams are pulsed on the top of the cornea. This is done till the cornea has been reshaped properly. Then a bandage that looks like a con

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

act lens is put over the eye and has to be kept on till the eye heals. The patient has to go and see the surgeon regularly in the course of the next few months.

For quite a few

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

weeks, the vision will alternate between blurry and good. So you might just have to wear glasses during this time. And it is recommended that you do at night. The eyes will hav

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

Professional from academic institutions, pharmaceutical industries, health care indust

e to be kept moist with eye drops. You should not be driving for a while after you have had PRK eye laser surgery. Sometimes, the best vision that you can expect after this sur

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

gery will come about in six weeks, sometimes it takes six months.

What you need to be very particular about is to get an ophthalmologist who is well-trained in PRK laser eye su

.

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

rgery. Make sure that you interview several and get referrals before you make your choice. Look at the fine print so there is no chance for misunderstandings or miscommunication

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

Companies that provide selfless information through particip

. And don’t be tempted to pick an ophthalmologist just because he offers a discount. In fact you should steer clear of those who give large discounts or use a lot of advertising

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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