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Red Eyes is the most common symptom of the eye which attracts attention of everybody. Usually the redness

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

of eyes is most often mistaken for conjunctivitis. Infact conjunctivitis is one of the many causes for red

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

Examples of combination products may in

yes, the others being glaucoma, iridocyclitis, corneal ulcer, scleritis, episcleritis etc. to name a few.

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

Most of the time conjunctivitis being viral in origin, there will be recovery even without treatment, where

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

s diseases like glaucoma, corneal ulcer etc., need urgent treatment. Otherwise they will cause permanent ir

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

Combination pro

reversible damage to the structure as well as the functions of the eye.

Some people use eye drops indiscri

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

inately. First of all self medication is dangerous. That too to use the medication prescribed for some oth

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

er disease is still dangerous.For example to treat an acute glaucoma, one has to use a drug called pilocarp

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

ne. If it is given in a case of iridocyclitis it will be disastrous. Similarly, atropine which should be gi

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

ven in a case of iridocyclitis and corneal ulcer, if given in a case of glaucoma, it could cause permanent

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

amage. So cross medication and self medication has got a deleterious effect especially in the treatment of

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

Following aspects would a

the red eyes.

The common bacterial conjunctivitis is treated with suitable antibiotics and frequent washin

dd to the challenges in developing combination products:

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

of eyes whereas corneal ulcer is treated with antibiotics, atropine and a pad to patch the eye (to give

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

rest to the eye ). The acute glaucoma in which there is sudden loss of vision with pain, redness, headache

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

nd vomiting is treated is treated with pilocarpine drops, systemic acetazolamide or injection mannitol. The

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

iridocyclitis in which there is gradual loss of vision with pain and redness is treated with atropine, ant

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

Professional from academic institutions, pharmaceutical industries, health care indust

biotics with local steroids as well as systemic steroids.

Most of the time the duration between the onse

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

t of the disease and initiation of the correct treatment has got an important role on the final result afte

.

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

the treatment in case of red eyes. So if this time is delayed, whatever be the reason, one is bound to los

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

Companies that provide selfless information through particip

e some amount of vision which he would have saved had he gone to the doctor at the earliest.

--Dr.H.S.Moha

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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