Advice Pool - Health and Fitness

Certain factors can cause poor drainage of aqueous fluids in the eye and this results in the build up of pressure which can cause damage to the optic nerves that helps the eye function for vision. This lea

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

ds to an eye disease called glaucoma and if left untreated, it can cause permanent loss of vision. Through the years many techniques and procedures have been developed to diagnose and treat it and at this

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

Examples of combination products may in

ime the most promising solution is glaucoma laser surgery.

Glaucoma comes in different forms and determining what type of glaucoma a patient has helps in determining what treatment options there are. Init

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

ially, in an attempt to relieve pressure in the eye, doctors give eye drops and medication taken orally are given. If it does not help, then glaucoma laser surgery is the next option.

Argon laser trabecul

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

plasty is one form of glaucoma laser surgery technique used primary open angle glaucoma. Tiny burns are made into the trabecular network of the eyes to improve the draining and flow of aqueous fluid in the

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

Combination pro

eyes. A specific form of this procedure is selective laser trabeculoplasty or SLT. This uses laser beams to remove only very specific target cells in the trabecular network. As a result, it improves the f

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

ow of aqueous fluids and relieves the pressure.

In some cases, it may take two sessions and in some, it may require repeating the procedure after two or three years. This, however is recommended because i

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

t avoids the need for medication after the procedure. It is also the glaucoma laser surgery procedure commonly recommended for pigmentary glaucoma which is common among males of African-American descent.

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

ngle closure glaucoma results if the space or angle between the iris and cornea is too narrow and this results in poor drainage of aqueous fluids. Peripheral iridotomy is the glaucoma laser surgery option

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

for this type.

To relieve the pressure, laser beams are used to make a small hole on the iris. The space or angle widens as the iris moves away from it. This corrects the flow of aqueous fluids.

For more

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

severe cases of glaucoma, the procedure usually recommended is laser cyclophotocoagulation. An example is when new blood vessels are formed in the eye as a result of diabetic retinopathy. The new blood ves

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

Following aspects would a

els can seriously affect the flow of aqueous fluids in the eye resulting in pressure buildup. This leads to a form of glaucoma called neovascular glaucoma.

For this glaucoma laser surgery procedure, the d

dd to the challenges in developing combination products:

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

octor uses endoscopic cyclophotocoagulation to observe the ciliary body. This is also connected to an endoscopic camera. This will then guide the application of the laser beam to treat the ciliary body so

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

it reduces or stops the production of fluids. By using a laser beam, part of the ciliary body is destroyed so that it no longer produces aqueous fluid. Less aqueous fluid means less pressure on the eye.

T

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

hese glaucoma laser surgery procedures are usually painless. Some may feel a slight stinging sensation but apart from that, no major pain is felt. After undergoing glaucoma laser surgery, some rest for a f

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

w days is required and soon one can go back to the normal daily routine.

Also, in some cases, the patient needs to take some medication to relieve some minor discomforts that may appear after the procedur

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

Professional from academic institutions, pharmaceutical industries, health care indust

e. Eye inflammation and slight risks in developing cataract may be some of the problems that may arise after each glaucoma laser surgery.

Glaucoma is a serious problem that can lead to permanent damage to

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

the eye. It is important that it is well-understood and that a number of techniques are available to treat it.

Laser surgery is fast becoming a popular option for glaucoma treatment. The techniques are al

.

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

so becoming more and more advanced and refined to ensure that treatment results only in success and there is complete absence of discomfort during and after the treatment. They are also being improved to m

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

Companies that provide selfless information through particip

ke the positive results long lasting, making glaucoma laser surgery a very promising form of treatment for glaucoma patients. As with any medical problem, thoroughly discuss all options with your physician

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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