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E-Articles - IntraLase and the Bureau of Naval Medicine
Laser eye surgeries like LASIK have been around for many years now, and they have helped millions of people
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
gain vision free from glasses or contacts, but it has never been approved for use on individuals in the U.
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
S. military aviation community.
The Bureau of Naval Medicine has chosen to allow four naval aviators to un
The Bureau of Naval Medicine has chosen to allow four naval aviators to un
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
dergo LASIK eye surgery using the IntraLase Method. So far, one aviator has already had the procedure perf
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ormed, and as soon as four hours after the LASIK surgery, his eyesight had reached 20/20 vision.
“This is
“This is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
a very important milestone in laser refractive eye surgery like LASIK because the U.S. Navy approval of the
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
IntraLase Method truly shows that this is the top of the line procedure, and is safe for people who underg
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
o even the harshest environmental conditions,” says Dr. Daniel Sambursky, a Syracuse, New York LASIK eye su
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
rgeon.
One of the reasons the Bureau of Naval Medicine has been hesitant about approving LASIK for their a
One of the reasons the Bureau of Naval Medicine has been hesitant about approving LASIK for their 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
viators is because of the environmental extremes they are often forced to endure, including high G-forces,
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
xtremely high altitudes, changes in air pressure, wind blasts, and dry air.
One of the reasons the Bureau
One of the reasons the Bureau
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
of Naval Medicine is allowing aviators to undergo LASIK now is because of the advancements made in the proc
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
edure. With the IntraLase Method, the entire LASIK procedure is performed with lasers, eliminating the use
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
of blades on the cornea.
With the IntraLase Method, an incredibly precise laser is used to create a flap
With the IntraLase Method, an incredibly precise laser is used to create a flap
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
in the cornea so that the LASIK procedure can be performed. In the past a blade called a microkeratome was
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
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
used to create the flap, but this also created higher instances of post-operative complications.
The Intr
The Intr
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
aLase creates the most optimal corneal surface possible so that the LASIK procedure can be performed with g
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
reater precision.
“I use the IntraLase Method to perform LASIK in my New York ophthalmology office because
“I use the IntraLase Method to perform LASIK in my New York ophthalmology office because
.
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
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
it produces better results with fewer complications that past LASIK methods,” says Dr. Sambursky. “Many o
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
f patients not only gain perfect, 20/20 vision, but they can even achieve vision that is better than 20/20.
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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