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Laser eye surgery comes at a high cost, and this is certainly a big factor for many people when choosing a laser eye practitioner. However, while finding an affordable vision clinic is i

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

mportant the biggest influence in your decision should be the ability and skill of the surgeon. Opting for a surgeon purely based on cost cutting may bring unsatisfactory results or, in

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

Examples of combination products may in

the worst case scenario, lose you your sight.

The importance of finding a good surgeon

Only a minority of patients achieve true 20/20 vision, although most patients will experie

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

ce a significant improvement in their vision which allows them to function on a daily basis without either contact lenses or glasses. However, there are also plenty patients who still re

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

quire use of glasses after surgery despite an overall improvement in their sight.

There are several reasons for this. Firstly, if the procedure is not performed meticulously then over

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

Combination pro

or under correction of the vision can occur. Secondly, it is common for laser eye surgery patients to develop very poor night vision and also see ‘halo’ effects appearing around lights.

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

his will necessitate the use of glasses in low-level light conditions, especially when driving. Lastly, patients with extremely poor vision may be unsuitable candidates for surgery at al

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

l, as achieving ‘perfect’ vision may be implausible. While the nature of laser eye treatment means that the risk of these side effects or problems can never be eradicated, however skille

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

d the surgeon, a good surgeon will vastly improve the chances of achieving a satisfactory outcome.

Another reason why it is imperative to find a reputable and highly skilled surgeon 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

hat the procedure is not without its risks. Lasik is considered the most risky form of laser eye surgery, but is also the most popular due to its quick recovery time. In Lasik, a small i

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

ncision needs to be made in the cornea to allow laser treatment to take place. If due care is not take, the flap may become detached. If the flap is also damaged, it might be impossible

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

Following aspects would a

to reattach it to the eye. While improbable, full or partial vision loss can result from surgery. The likelihood of complications arising diminishes if you are in the hands of a highly q

dd to the challenges in developing combination products:

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

alified and experienced laser eye practitioner.

How to find a reputable surgeon

Your first step in finding a good surgeon should be to first find a reputable clinic. Be wary of

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

vision clinics making outrageous claims such as ‘20/20 vision guaranteed’ or ‘perfect vision or your money back’. Before finding a clinic, research what can realistically expected from t

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

he laser eye surgery. If a clinic is making promises that they cannot guarantee delivery on, they may not be a good choice for your surgery. The best clinic is one which is honest about

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

he potential results of laser eye treatment, both good and bad.

Compare as many clinics as possible. This does not just include the cost, although that is still a consideration for most

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

Professional from academic institutions, pharmaceutical industries, health care indust

people. Equipment can vary from clinic to clinic. Ideally, you should opt for surgery somewhere which provides the most up to date procedures and uses FDA approved equipment.

Ask your

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

surgeon about his qualifications and training. It is also prudent to ask how many procedures he has carried out, particularly in the type of laser eye treatment you have opted for (for e

.

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

ample Lasik or PRK). A good surgeon will be very thorough when discussing the procedure and will outline the potential risks, the side effects and what results you can realistically expe

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

Companies that provide selfless information through particip

ct.

To locate a clinic or surgeon try searching the internet or asking your optician for a referral. American patients may also wish to visit American Academy of Ophthalmology's website

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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