Advice Pool - Health and Fitness

Over 100,000 people in the UK undergo laser eye treatment every year. The surgery corrects the patient’s vision by shaping the cornea, which controls how

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

well the eye focuses, with a very precise laser. Between 80 and 98 percent of treatments improve the sight sufficiently for the patient to no longer requi

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

Examples of combination products may in

re either glasses or contact lenses.

At present, there are two popular methods of laser eye surgery. The most commonly used form of laser treatment is La

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

sik. In Lasik, a small incision is made in the cornea to create a flap. Laser treatment can then be carried out. There may be vision loss of 20 to 30 seco

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

nds during the procedure. In Lasek the epithelium is removed before the cornea is reshaped with a laser. Laser eye treatment takes around 15 minutes in to

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

Combination pro

tal.

For many patients, Lasik is a much more desirable option than Lasek treatment. After undergoing Lasek, the patient may experience moderate levels o

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

f pain for around 24 hours post surgery. Extreme sensitivity to light is also common for the first couple of days and you will be required to wear sunglas

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

ses outdoors for three months. Vision can also remain hazy or blurred for up to a week and it takes around a month before the patient’s vision will ‘settl

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

e down’ and the final results of the surgery are known. With Lasik treatment, there is very little post operative discomfort and the results of surgery ar

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

e apparent much more quickly. Vision should initially be much less blurred than after undergoing Lasek, and the blurriness should dispel within 48 hours.

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

A Lasik patient will probably be able to see well the day after treatment.

For a minority of patients, PRK will be recommended over Lasik or Lasek if the

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

Following aspects would a

patient has a particularly thin cornea. PRK was the forerunner of Lasek and works by using an excimer laser to remove a thin layer of cells from the surf

dd to the challenges in developing combination products:

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

ace of the cornea to reshape the eye. No incision is required. The main difference between Lasek and PRK is that in PRK the cells are scraped off and the

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

epithelium is left to grow back after the treatment, which takes several days. In Lasek, the epithelium is removed with a weak alcohol solution and then r

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

eplaced immediately after surgery. A contact lens has to be worn for several days to hold it in place.

PRK has been around for over a decade and to date

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

there seems to be no harmful long term effects. Lasek is also considered fairly low risk. This is largely due to the fact no incision is required for surg

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

Professional from academic institutions, pharmaceutical industries, health care indust

ery in either of these laser eye treatments. Lasik, despite its benefits, is considered to be the riskiest form of laser eye surgery. The potential compli

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

cations include corneal ectasia, where a build up of pressure occurs behind the weakened cornea. Further surgery is required to correct this otherwise a r

.

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

apid degeneration may occur in the eye sight.

The effects of laser eye surgery are permanent, but the treatment cannot prevent further age-related deteri

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

Companies that provide selfless information through particip

oration.

If you are considering laser eye surgery, book a consultation at a reputable vision clinic where a doctor can assess the best treatment for you.

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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