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It is a form of refractive laser eye surgery procedure performed by ophthalmologi

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

sts intended for correcting myopia, hyperopia, and astigmatism.

The basic premise

; 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 a LASIK eye surgery is to reshape the clear dome from the front surface from the part of

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

the eye that focuses light into the retina, which is called the cornea.

Post Op

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

rative evaluations and exams includes the following:

Eye Exam

Measuremen

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

Combination pro

t of Pupil

Corneal Topography

Corneal Thickness Measurement

Dry

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

Eye Evaluation

Cycloplegic Dilated Exam

After completion

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

of the LASIK surgery, examinations are required 1 day, 1 week, 1 month and 3 months. These

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

critical appointments help in evaluating the eye's healing process as well as to guard and

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

prevent against infections.

For the most part, the vast majority of LASIK patients

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

are highly satisfied. Most mention that the quality of their lives and daily routines have

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

Following aspects would a

improved. Many surveys conducted have found that over 95% of LASIK patients mention that

dd to the challenges in developing combination products:

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

they are very satisfied.

Potential Risk and Complications can occur d

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

uring and/or after surgery

Finding the right doctor is a critical part of having a

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

successful LASIK experience.

Not everyone meets the criteria for LASIK eye surg

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

ery. It is important to understand who does and who does not meet these criteria. LASIK is

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

Professional from academic institutions, pharmaceutical industries, health care indust

efractive surgery on the cornea or lens of the eye. It does not solve blindness, problems

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

with vision due to the brain, or vision problems that come upon again. LASIK is primarily

.

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

for those with myopia(nearsightedness), Hyperopia(farsightedness), or astigmatism(a distort

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

Companies that provide selfless information through particip

ion of the image on the retina caused by irregularities in the cornea or lens).

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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