Article Dump - Health and Fitness

While laser eye surgery isn’t particularly difficult technically, there are risks and side effects, as with any surgery. It’s not unusual to feel some discomfort and perhaps have blurry

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

vision for the first few days. But there can be more serious problems:

* PRK and infection

PRK is a less complicated operation, so there’s less risk of surgical error. But there

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

Examples of combination products may in

is a slightly greater chance of infection while healing (around one in 1000) than with LASIK. This may delay healing but usually doesn’t cause long-term problems.

* LASIK and damage t

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

o the corneal flap

With LASIK there is a slight risk — about one in 500 — that the corneal flap will be cut off or damaged. If the flap is put back in the correct position, there s

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

hould be no adverse effects. But if the flap is lost, this will lead to long-sightedness and irregular scarring of the remaining corneal bed, leading to haze and blur.

* Undercorrectio

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

Combination pro

n

In around one out of 15 cases, the surgery results in undercorrected vision and the operation has to be redone. Find out beforehand whether your payment includes further treatmen

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

t in such a situation.

* Problems with night vision

Some patients end up with 20/20 vision but have irritating or distressing side effects, the most common being night vision prob

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

ems: estimates range from around 4% to 30% of patients, depending on the time since surgery and how much of a problem the symptoms cause (from being a regular annoyance to only just not

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

iceable).

Almost all patients have some symptoms in the first couple of weeks, but their severity diminishes over time. The effects can be particularly problematic when driving, when t

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

here’s a loss of contrast sensitivity and headlights appear much bigger, are blurry or have halos around them. For this reason, most county and city police forces in England and Wales w

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

on’t employ anyone who’s had laser eye surgery.

Around 1% of people are permanently affected and can’t drive at night as a result of these side effects.

Your surgeon should check your

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

Following aspects would a

pupil size in darkness before the operation: if it’s more than 7 mm you’re more likely to have night vision problems and should reconsider having the surgery. But a pupil size smaller

dd to the challenges in developing combination products:

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

than 7 mm is no guarantee you won’t suffer these problems. Poor night vision can sometimes be corrected with eyedrops that reduce pupil size (for example, Pilocarpine, which contracts t

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

he pupils), or by wearing contact lenses at night. With newer laser treatments and improved techniques, these side effects are becoming less common.

* Worse than before?

A small p

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

oportion of people (around one to three per thousand) end up with poorer ‘best-corrected’ vision — that is, worse vision than they had with glasses or contacts before the operation — be

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

cause of corneal haze or irregular tissue removal. Worse complications are very rare.

* Long-term complications?

Although the procedures are relatively new and the long-term risks

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

Professional from academic institutions, pharmaceutical industries, health care indust

unknown, many experts say there’s no reason to suspect any significant long-term complications.

Some, however, have raised concerns about lasers thinning the cornea, which already get

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

s thinner as you age. This results in an increased risk of developing corneal ectasia or keratectasia (where the cornea bulges forward, distorting vision and causing short sight again),

.

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

limiting the potential for laser surgery for corneal diseases in later life and increasing susceptibility to corneal rupture.

Laser surgery is a rapidly evolving field of knowledge an

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

Companies that provide selfless information through particip

d expertise, and continual refinements based on improved technology and findings from scientific studies are likely to reduce the risk of minor side effects as well as more major damage

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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