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Each Child is important to an individual family. It is but natural that parents become anxious if there is any problem to any of the organs of the child. As the eyes are important and very precious, they would be concerned if their daughter or son has eye probl

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

ems.

There are many eye problems that are commonly found in children. The major problem is the refractive error, the common mode of presentation is that the child is not able to see the distant objects usually seen in the school where the child fails to see cl

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

Examples of combination products may in

arly the letters written by the teacher on the blackboard. Most of the time the child holds the book very close to the eyes while reading. And also child watches TV and Computers from a very close distance.

The other problems are – Vitamin A deficiency, Squin

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

eyes and Retinoblastoma (Eye Cancer).

Refractive Errors:

There are mainly three types of refractive errors. Myopia, Hypermetropia and Astigmatism.

Myopia : This is the most common refractive error found in children. Usually it is detected when the child i

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

having problem in seeing distant objects. Occasionally the child may have a slight pain in the eyes after reading for many hours. The light rays are focused in front of the retina in myopia with the result that the objects appear hazy.( If we have to see a cle

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

Combination pro

r object it has to be focused on the retina.) Sometimes it has a strong family history. The eye has to be properly examined by a competent Ophthalmologist (not by an Optometrist) and suitable glasses prescribed at the earliest. Regular follow - up is also a mus

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

in these children.

Astigmatism is another refractive error seen in children not as frequently as Myopia. Hypermetropia where the child has + numbers in glass, is comparatively less in frequency. Suitable glasses correct both these refractive errors.

Vitamin

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

Deficiency:

Vitamin A Deficiency is demonstrated in school going children. Usually children in the age group of 6-12 years complain of night blindness. In other words those children have inability in seeing objects clearly in dim light. Sometimes small pigmen

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

ed patches are seen by the side of the cornea. These are called Bitot’s spots. At this stage the child has lot of watering in the eyes.

A substance called visual purple has to be created in the retina to visualize objects clearly in the dim light. Vitamin A is

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

necessary to create this object. When there is deficiency of Vitamin A in the diet, child gets night blindness. Sometimes some skin problems are associated along with eye problems.

Vitamin A deficiency is treated by giving capsules of Vit.A 2500-5000 IU or 750

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

mg of beta-carotene. In severe cases injections may be needed. Green leafy vegetables, carrots, milk, curd, butter, egg, liver etc., have rich contents of Vitamin A.

Squint Eyes : The two eyes normally should be in a definite visual axis. A manifest deviation

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

Following aspects would a

f the visual axis of either eye is known as squint or strabismus. Mainly there are two types of squints – Paralytic and Non-paralytic or Concomitant. Concomitant is the one which is mostly seen in children. Concomitant deviations are for the most part, produced

dd to the challenges in developing combination products:

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

by anomalies of the power of convergence and divergence and the co-ordinated use of the two eyes to obtain binocular single vision. In these cases the amount and character of the deviation does not vary when the eyes are turned to the right or left.

The other

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

lassification of squint is – Convergent and Divergent. Convergent squint is the one in which one of the eye is turned inside, whereas in divergent squint one of the eye is turned outside.

Each child with squint has to be properly investigated before undertakin

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

treatment. The common methods of treatment are – 1) Correcting the refractive errors by glasses whenever that is found to be the cause of the squint. 2) Deliberate occlusion or patching of the fixing eye so as to improve the vision of the squinting eye. 3) Sug

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

esting special type of ( Orthoptic) exercises to improve the binocular faculties. 4) By surgery to restore parallelism of the visual axis. One or more of these methods or all four may be needed.

Retinoblastoma: It is the cancer or malignant tumor of the eye ,

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

Professional from academic institutions, pharmaceutical industries, health care indust

sually seen in children below 5 years. It may be seen at birth or later. This disease not only affects the vision, but also life itself if it is not diagnosed and treated properly at an appropriate time. It may be seen in one eye or both.

Usually the child is

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

rought to the eye specialist with the complaint that something white or yellow material is seen in the eye. If one eye is swollen enormously, it is understood that the disease is advanced. Treatment is usually removal of the eyeball as soon as the disease is di

.

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

gnosed and the cut portion sent for biopsy. After the removal of the eyeball, if there are any signs of the disease,

Radiotherapy is advised. At this stage the other eye is examined and if any traces are found it is also subjected to radiotherapy. In the advan

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

Companies that provide selfless information through particip

ed stage of the disease, it is mandatory to treat with chemotherapy.

Apart from these eye injuries, congenital cataract and glaucoma are the other diseases of children. Parents and teachers have great responsibility in the proper management of the eye diseases

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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