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An estimated 20% of the world’s population suffers from allergic disease and may present as red itchy eyes, rhinitis (runny nose), asthma, and allergic co

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

njunctivitis.

Ocular allergies are specific immunologic changes that result in inflammation on the conjunctival surface. This is a response to an increas

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

Examples of combination products may in

ed level of Mast cells in the surface tissue and will result in a mild allergic reaction. When immunoglobulin E is introduced and interacts with a mixture

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

of mast cells, lymphocytes and eosinophils, the allergic response is more severe and corneal involvement is much more likely.

There are several types of

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

allergic reactions that affect the eyes. Seasonal allergic conjunctivitis is one of the most common types and is a typical reaction to Ragweed pollen and

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

Combination pro

ther environmental allergens. Perennial allergic conjunctivitis is a variant of the seasonal type, but reoccurs yearly in response to exposure to a certai

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

n allergen. Vernal conjunctivitis is uncommon and is a chronic type of the seasonal allergic conjunctivitis. This type more often occurs in children. Gian

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

Papillary Conjunctivitis is most often associated with contact lens wear and is a reaction to exposure to surface debris. It results in follicles and pap

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

illa (bumps) on the inside surface of the lids. Finally, contact dermatitis is an acute response to exposure to an allergen. It results from touching an a

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

lergen and then rubbing the face or eye lids. This causes exposure and red, itchy, scaly skin is the result. There may be ocular involvement if the eye is

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

exposed as well as the skin.

Treatment options vary depending on which allergy the patient suffers from. Surface allergies like contact dermatitis are b

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

Following aspects would a

est treated initially by cool compresses. Oral antihistamines interfere with systemic involvement, but are not the best choice for the surface disease of

dd to the challenges in developing combination products:

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

he eyes. Vasoconstrictors are available over the counter, but don’t work that well for moderate to severe reactions.

Mast cell stabilizers have been arou

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

nd for some time and are effective in reducing some of the symptoms, but still leave the patient uncomfortable. The newest treatment modality is the combi

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

ation multi-action surface medicine like Patanol and Pataday. This medication is comprised of mast cell stabilizers and antihistamines. They attack the en

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

tire source of the disease process. Relief is quick and with Pataday which is a single does per 24 hours, long lasting and easy to use. The only stronger

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

Professional from academic institutions, pharmaceutical industries, health care indust

opical medication is steroids. They will resolve the symptoms and red eyes and are used in severe allergic reactions. The only problem is that they can NO

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

T be used for prolonged treatment due to the severe side affects. When a bad allergy is encountered, steroids can be employed to start the treatment and t

.

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

en change to medications like Patanol/Pataday for long term therapy.

In short, ocular allergies are very common and cause substantial discomfort in affec

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

Companies that provide selfless information through particip

ted individuals. New treatments and medications eliminate these symptoms and permit the individual to live a normal life during previously difficult times

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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