Advice Pool - Health and Fitness

Diabetes is the main cause of blindness in adults in the United States. The most common form of Diabetes is type 2 diabete

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

s. In the United States, diabetes is responsible for 7 percent of legal blindness, making it the leading cause of new case

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

Examples of combination products may in

s of blindness in adults 22 to 70 years old. Although eye problems are a major concern for type 2 diabetics, most people w

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 have diabetes only have minor eye disorders. The key to keeping these problems from escalating is early prevention.

Eye

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

problems are a long-term complication in type 2 diabetics. High glucose levels and high blood pressure, can cause common

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

Combination pro

ision problems such as, Diabetic retinopathy, glaucoma, and cataracts which are the most common eye problems found in type

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

2 diabetics.

Diabetic retinopathy is the leading cause of blindness in adults. The retina has tiny blood vessels that ar

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

e easily damaged by high blood sugar and high blood pressure. Diabetic retinopathy may pertain to retinal blood vessels th

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

t swell and leak fluid, or may have abnormal new blood vessels grow on the surface of the retina. A serious complication

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

from diabetic retinopathy is a detached retina. This condition requires immediate attention from your eye doctor.

Glaucom

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

is another condition common in those diagnosed with type 2 diabetes. Any one can get glaucoma, especially if there is fa

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

Following aspects would a

mily history of glaucoma. Diabetics are twice as likely to get glaucoma as non-diabetics.

Cataracts are more common, and

dd to the challenges in developing combination products:

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

often occur in the earlier stages of diabetes, and in people who smoke.

Eye problems are common in those diagnosed with t

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

pe 2 diabetes and most cannot be prevented. Patients who monitor thier diabetes do better than those who are in less contr

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

ol of their illness. A diabetic who closely monitors their glucose levels can still develop diabetic retinopathy. It is ve

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

y important that you have yearly retinal exams to prevent permanent blindness. To prevent eye problems associated with typ

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

Professional from academic institutions, pharmaceutical industries, health care indust

e 2 diabetes:

keep your blood sugar levels under control

keep your blood pressure under control

do not smoke

immediate

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

ly report any changes in vision, even blurred vision

have eye exams performed yearly or as often as recommended by your d

.

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

ctor and

if you are pregnant, have an eye exam during the first 3 months of the pregnancy

Schedule a yearly eye exam tha

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

Companies that provide selfless information through particip

t checks for diabetic retinopathy, glaucoma, and cataracts, do not wait for a vision change to occur to see the eye doctor

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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