Advice Pool - Health and Fitness

LASIK, surgery to reduce or eliminate the need for eye glasses, has become very popular over the past 5-10 years. While most cases proceed quite well, the potential f

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

or complications does exist, and is often not discussed prior to surgery. It should be noted that all but one of the complications is NOT due to surgeon error. Most p

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

Examples of combination products may in

tential problems are simply physiological, and have nothing to do with how well the surgeon performed the procedure.

The first is infection. While topical antibiotic

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

s are employed prior to, and after the surgery, there is always the possibility of infection if the individual is exposed to an infectious agent. The cure is simple;

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

roper follow up and more antibiotics. There is minimal risk of further issues.

The second, is movement of the flap. This will occur if the individual rubs his/her ey

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

Combination pro

e before the flap has had proper time to reattach itself to the underlying tissue. The patient will experience pain, blurry vision and redness if this occurs. It is a

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

emergency, and does require being brought back into surgery to move the flap back into position. Once this is done, the individual should heal normally without furth

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

er complications. This flap movement tends to occur more frequently when Intralase (laser is used to lift the flap) is performed. While the incision is more precise,

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

t results in a very thin flap which tends to move easier post surgically. Once the flap heals though, the incision area is barely noticeable.

The third complication

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

is epithelial (outside) cell growth under the flap. This may occur days to months after surgery. These cells grow around the edge of the flap, and move inward causing

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

haziness under the flap. When this occurs, the flap must me lifted up and these epithelial cells washed away. No further problems will occur after this procedure is d

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

Following aspects would a

ne.

The fourth issue is striae, or wrinkles in or under the flap. This is corrected by lifting the flap and flattening it out. No long term issues after this point.

dd to the challenges in developing combination products:

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

Issue five is extreme swelling often called ” Sands of the Sahara”, because it looks like a sand dune to the examining eye doctor. This may occur more frequently, b

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

t is dealt with higher doses of steroid eye drops to reduce the inflammation. As with the other complications, the results are most often successful.

The final and m

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

ost serious of the potential complication is ectasia. This occurs when the inner most layer of the cornea, the endothelium, has irregularities in it. If this issue is

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

not detected prior to surgery the final results after LASIK may be terrible. The patient may have poor, distorted and irregular vision that is NOT surgically correcta

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

Professional from academic institutions, pharmaceutical industries, health care indust

ble, nor corrected with glasses. Most often the individual will either have to wear hard contact lenses, and may even require a cornea transplant to improve his/her v

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

sion. This complication is the only one that could be surgeon related. A test called the Orbscan MUST be performed prior to surgery, and the potential for ectasia can

.

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

be easily detected. NO INDIVIDUAL SHOULD EVER consider LASIK with out having an Orbscan done. Any office that does not have an Orbscan should not perform LASIK.

As

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

Companies that provide selfless information through particip

ith all surgical procedures, patients must be comfortable with the surgeon and the office they choose, and understand all the potential complications prior to surgery

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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