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Cataract is a condition in which the eye lens becomes progressively opaque. In the initial stage, the crystalline lens may be increased causing myopia and soo

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

n accumulation of brown pigment within the lens may reduce the perception of blue colors. Slowly the cataracts will cause loss of vision and one can become bl

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

Examples of combination products may in

ind completely if it’s not given timely treatment. Another fatal cause is that the cataract cortex sometimes liquefies to form a milky white fluid in a morgag

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

nian cataract, leading to severe inflammation when lens capsule ruptures and leaks, causing phacomorphic glaucoma. Varied reasons are given for the formatio

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

n of cataracts. Some are caused due to exposure to ultraviolet rays, effects of diseases like diabetes, advanced age when the lens gets weakened, genetic fact

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

Combination pro

ors and eye injuries.

Types of cataracts

• Age-related cataract

• Immature Senile Cataract which leads to partially opaque lens and disc view is hazy.

• M

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

ature Senile Cataract has completely opaque lens.

• Hyper mature Senile Cataract has liquefied cortical matter:

• Congenital cataract

• Sutural cataract

•

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

Lamellar cataract

• Zonular cataract

• Total cataract

• Secondary cataract

• Drug-induced cataract

• Traumatic cataract and

• Blunt trauma Penetrating

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

trauma which has capsular rupture and leakage of lens material.

Treatment:

Surgery is considered the most effective treatment for the removal of cataract. O

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

ne type of cataract surgery is the Extra-capsular surgery which removes the affected lens only, leaving the majority of the lens capsule intact. The other sur

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

gical removal of the cataract is Intra-capsular surgery which removes the entire lens of the eye. This surgery replaces the cataractous lens with a permanent

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

Following aspects would a

plastic lens.

Due to its low cost and also its affinity, polymethylmethacrylate PMMA is widely used to replace the cataract lens. A softer and more expensive

dd to the challenges in developing combination products:

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

one is the silicon acrylate which can be folded and inserted into the eye through a smaller incision. It’s specially recommended for those with a history of

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

uvetus or at risky stage of retinal detachment. There is also the latest approved multifocal intraocular lens implants which enables most post operative catar

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

act patients the advantage of glass free vision and they are costly too, can rise up to $1500 per eye. But then one’s eye is very precious, it’s worth the amo

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

unt spent indeed.

For cataract operations, one needs only a day. In fact the patient can leave for home the same day itself. Although yes, risk cases arise o

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

Professional from academic institutions, pharmaceutical industries, health care indust

nly after the surgery’s done. Cases such as thickening and clouding of the lens capsule are common, though it can be quickly corrected using a laser. Well, re

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

tinal detachment is another complication of cataract surgery with those patients of extreme myopia.

Prevention:

• Protecting the eye from ultra violet rays

.

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

by using good sunglasses, which will to an extent reduce the development of cataracts.

• Regular intake of antioxidants like vitamin C and E.

• Stalin’s als

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

Companies that provide selfless information through particip

o have a stable ability to reduce lipids; especially its oxidative quality is useful in the development of nuclear cataracts, which is an age related cataract

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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