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Patients seeking permanent correction of common vision problems such as nearsightedness now have a choice between surgically implanted lenses

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

, called phakic IOLs (intraocular lenses), or the traditional LASIK surgery. Both procedures work by changing the way light rays enter the ey

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

Examples of combination products may in

e and both procedures can help sharpen vision and greatly diminish dependency on glasses or contact lenses. The type of laser eye surgery or

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

lens implant recommended will be based on the age of the patient, corneal thickness and the health and lifestyle of the individual.

LASIK Ey

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

e Surgery

LASIK uses energy to reshape the cornea and is effective in treating nearsightedness (myopia), but is not recommended for patients

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

Combination pro

with severe vision impairment. The reshaping of the cornea in LASIK is permanent as it involves removal of tissue from the cornea of the eye,

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

thus changing its shape. The eye surgeon uses a computer to calculate the exact amount of cornea that needs to be removed from each patient'

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

s eye, and then he creates a thin cellophane flap on the surface of the cornea. The surgeon then lifts the flap, positions the laser and deli

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

vers a pre-determined number of ultraviolet light pulses onto the newly exposed part of the cornea. Every pulse of the laser removes a micros

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

copic layer of cornea.

When the LASIK surgery is complete the flap is put back in place without stitches so that it can adhere naturally to

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

he treated cornea. This procedure flattens the center of the cornea, enabling light rays to be more focused and precise on the retina, thus m

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

Following aspects would a

aking images more sharp and clear. Several different forms of LASIK are used today, each depending on how the flap on the cornea is created.

dd to the challenges in developing combination products:

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

Lens Implants

Patients that do not qualify for LASIK because of very high myopia or very thin corneas are potential candidates for surgical

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

ly implanted lenses, also called phakic IOLs (intraocular lenses). This new option offers a more permanent correction of common vision errors

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

such as myopia (nearsightedness). These implants, which bear a similarity to contact lenses, are placed between the cornea and the iris. Som

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

eye surgeons consider IOLs the best option for extreme nearsightedness. Unlike traditional lens implants, which typically provide clarity in

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

Professional from academic institutions, pharmaceutical industries, health care indust

either near, intermediate, or distance ranges, multifocal and accommodating lens implants offer the prospect of good vision at more than one

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

range.

Unlike LASIK, surgically implanted lenses do not require tissue removal from the eye. The patients natural lens remains in place to

.

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

focus from far to near in a natural way, it is intended for younger patients who are still able to focus well, but may also be used on older

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

Companies that provide selfless information through particip

patients as long as they retain sufficient focusing ability. Convenience and reversibility are just a few of the advantages of this procedure

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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