Advice Pool - Health and Fitness

All forms of surgery carry inherent risks. The nature of laser eye surgery means that the fear of unforeseen complications can be immense as if problems

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

do arise then the damage may be irreversible. People considering laser eye surgery are often particularly afraid they may lose their sight. So how risky

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

Examples of combination products may in

s laser eye surgery, and what are the complications that can arise?

Although the risk is very small – less than 5 percent - the corneal flap can become

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

etached from the eye during the procedure. In some instances the surgeon may be able to reattach it, although in a small number of cases this is not poss

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

ble and there is permanent sight damage.

Post operatively, patients have between a 5 and 10 percent chance, (depending on the type of laser eye treatmen

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

Combination pro

t used), of developing an infection under the corneal flap where the incision was made for surgery. In most instances this does not cause lasting damage

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

ut it can slow down the healing process. Another rare complication is corneal ectasia, where ‘bulging’ is caused by a build up of pressure against the we

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

kened cornea. The condition can be cured by a highly skilled surgeon through a corneal transplant. If left untreated the vision may become progressively

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

orse.

There are several risks which are considered ‘normal’ by laser eye practitioners, and should not cause undue concern as the effects should not be

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

permanent. The eyes may remain sensitive for several months which means, if surgery did not result in 20/20 vision and the use of contact lenses is still

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

a necessity, that the eyes can become very uncomfortable. Dry eyes are also a common side effect and patients often require drops for six months to lubr

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

Following aspects would a

cate the eyes.

Night vision can be impaired by laser eye surgery, which can make driving at night inadvisable. Seeing a ‘halo’ effect around lights is a

dd to the challenges in developing combination products:

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

so an associated risk of the procedure, and can also make driving after dark potentially dangerous. Both of these problems can be temporary, lasting betw

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

een 6 and 12 months, but unfortunately this is not the case for all patients.

To reduce the risk of complications, spend time researching reputable clin

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

cs and doctors. While there are many qualified and highly skilled practitioners there are also many doctors who lack proper training and experience in la

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

er eye treatment. Any doctor can carry out the surgery after just one weeks training, and there is no specialist qualification required to perform laser

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

Professional from academic institutions, pharmaceutical industries, health care indust

ye surgery. Success rates can vary significantly between vision clinics. Always ask plenty questions to ascertain the level of skill of the surgeon, such

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

as his qualifications and number of surgeries performed. It is also prudent to check if the equipment at the clinic is FDA approved, as not all clinics

.

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

ill be using the latest (and potentially safest) equipment.

To diminish the risks of laser eye surgery further still, opt to have just one eye operated

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

Companies that provide selfless information through particip

n at a time. If the first operation presents no problem and the results are favorable a second operation can be booked to correct vision in the other eye

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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