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E-Articles - Key Facts About Lasik - What Are Some Lasik Complications?
After over 15 years of successful procedures and continual development, Lasik eye surgery has blossome
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
d into an extremely safe and predictable procedure. However like all forms of surgery, complications can arise
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
Complications can occur at the preoperative, intra-operative, and postoperative stages of the Lasik procedure
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
A thorough medical examination before Lasik is recommended to unearth any preoperative complicati
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ons. The physician can then determine early on whether Lasik is possible at all or if there are conraindicatio
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
s. Preoperative complications can result from such factors as dry eyes or eye infections.
To minimize the pos
To minimize the pos
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
ibility of such occurrences, surgeons can make various recommend. They recommend patients stop using contact l
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
enses a week before the surgery, for example. Other complications include keratoconus (a genetic condition tha
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
causes the cornea to become thinner after the surgery).
Intra-operative complications may result from the in
Intra-operative complications may result from the in
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
xperience on the part of the surgeon or inadequate hygiene in the operating room. A slipped flap is one of the
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
most common complications. It happens when a corneal flap detaches itself from the rest of the cornea. In this
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
case, the surgeon would advise the patient to go home and sleep to give the flap a chance to heal.
After the
After the
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
operation, the patient may suffer from an eye infection, usually under the corneal flap. This might result fro
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
a lack of hygiene or the carelessness of the patient after surgery (he must not expose the eye to any dust or
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
smoke, for example). Such infections are treatable with antibiotics.
Another postoperative complication is t
Another postoperative complication is t
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
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 possibility of developing persistent dry eye. Persistent dry eye is caused by a reduction in the number of c
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
rneal nerve fibers resulting from the Lasik procedure. Up to a half of the fibres can be lost and since they a
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
re responsible for the production of tears, dry eyes can result. Incidence of sub-conjunctival hemorrhage is a
.
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
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
other possible complication, too.
These complications are rare and most have remedies. Remember that thousand
These complications are rare and most have remedies. Remember that thousand
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
of people have undergone Lasik without any problems. Lasik is a very safe and problem-free surgical procedure
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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