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  • Advice Pool - Bladeless Vision Correction

    According to the surveys, approximately 2 million refractive eye surgery (RES) procedures were performed in the United States during 2004 and 2005.

    To put
    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
    it nicely: RES is used to improve the refractive state of the eye and decrease dependency on glasses or contact lenses. The most common methods today use la
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    ers to reshape the cornea. Successful refractive eye surgery can help to reduce such common vision disorders as myopia, hyperopia and astigmatism.

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

    ifferent LASIKs eye surgeries are available today. Many still prefer the original laser eye surgery (PRK, Photorefractive keratectomy). Custom LASIK surger
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    (Laser Assisted In-Situ Keratomileusis, also known as wavefront LASIK or wavefront-guide LASIK) uses 3-dimensional measurements of how your eye processes i
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ages to guide the laser in reshaping the cornea. It is performed for a wide range of nearsightedness. The surgeon uses an instrument called a microkeratome
    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
    o cut a flap of corneal tissue, opens the flap like a hinged door, removes the targeted tissue in the corneal stroma beneath it with the excimer laser, and
    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
    hen replaces the flap. Some variations don't use a microkeratome but cut the flap with a laser: IntraLase “Bladeless” LASIK.

    While LASIK is a relatively lo
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    risk surgery, bladeless LASIK eliminates the one area where most complications arise, the metal blade. Aside from the fear it strikes into the heart of th
    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
    se who fear traditional surgery, it still has a very human error rate in a very difficult low-percentage situation.

    While many people who are rejected for
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    ASIK are rejected for thin corneas, bladeless LASIK offers these people a second chance. IntraLase lasers offer a more controlled environment in the bladel
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    ess LASIK surgery. Instead of cutting through with a blade, the laser is guided by computer technology.

    The IntraLase laser allows for more curvature duri
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    g the bladeless LASIK surgery, reducing the margin for error. The fact that it is a laser and not a blade also lends to the idea of avoiding infections or
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    ontaminations. Bladeless LASIK prevents long-term recovery that accompanies most surgeries.

    Prior to LASIK a lot of people had unsafe or imperfect surgeri
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    s to correct vision that eliminated them from the opportunity to try LASIK. With bladeless LASIK, these potential customers get a second chance because of
    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
    he near 100% success rate of the procedure.

    Some patients follow traditional LASIK with follow-ups to make other corneal flaps or reduce eye-irritation. B
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    adeless LASIK with InterLase appear to have reduced the possibility of this happening.

    The natural reaction to the thought of bladeless LASIK is that it el
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    minates the need for a practiced and season doctor to perform the surgery. While it may be true to a point, the fact is that bladeless LASIK requires a goo
    .

    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
    deal of knowledge in physics and engineering.

    While surgeons may have only been required to have knowledge of medicine and anatomy in the past, they now m
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    st be computer savvy. The advantages of bladeless LASIK seem to boil down to two basic ideas, a higher success rate and less chance of follow-up procedures


    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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