Posts Tagged ‘fda approval’

The debate on Lucentis and Avastin

For those 200,000 AMD patients within an average year in US, the most effective treatment that approved by FDA is Lucentis. It brings hope to wet AMD patients by stopping and sometimes reversing vision loss, which is a huge breakthrough. Yet another drug that is similar to Lucentis is also under wide discussion, which is named Avastin. But Avastin is much cheaper than Lucentis, so that many doctors recommend Avastin for low-income individuals.

However, Avastin has not received FDA approval for ophthalmic uses. Based on safety issues, Genentech also restricts the sale of Avastin to compounding pharmacies for ocular uses. Both Lucentis and Avastin are owned by this company. Since the FDA has expressed no concern about the Avastin’s off label uses for AMD, many eye doctors argue that Genentech should allow Avastin to be directly sold to both physicians and compounding pharmacies. If only physicians have access to Avastin, doctors at the American Academy of Ophthalmology protest that many lower income people will be deprived of this sight-saving drug. The fact is that Lucentis cost an average of $2,000, while Avastin only needs $150.

During the widely off-label uses of Avastin, this treatment has not been proved to be as effective as Lucentis, or even more effective. No clinical study has made a comparison between the two AMD treatments. The most concern is their price discrepancy. Even if Medicare and other health insurance plans offset parts of the Lucentis expense, it is still much more expensive than Avastin. For example, patients with Medicare may only need to pay a 20% of co-payment for Lucentis, which equals about $400.

Genentech has given explanations about its different policies of the two drugs. Genentech officials say that the high price of Lucentis comes from its special development and its considerable expense of clinical trials. Lucentis is administered in the form of smaller molecules, which are more effective in controlling abnormal blood vessels. The company also claims that they will not conduct new trials for Avastin, since Lucentis has already got FDA approval and is a promising AMD solution. The good news may be that the US government is likely to fund the comparison between Lucentis and Avastin.

While the initial use of Avastin for colon and other cancers was reported to arouse risks of stroke and heart attack, its use for macular degeneration has brought no negative side effects. Most of the doctors are positive about the Avastin’s long-term safety risks. Due to its low price, researchers encourage the use of Avastin. There are also concerns that Avastin may be unable to penetrate the eye’s retina effectively. The undergoing two-year NEI clinical trails may settle down all these controversies.

Article Source:http://vision.firmoo.com/eye-diseases/debate-on-lucentis-and-avastin.html

Vision Library is the information source in area of vision care, including eyeglasses, sunglasses, contact lenses, sports protective eyewear, vision error and diseases, vision surgery, ageing and kid’s vision etc., solely sponsored by Firmoo.com, an emerging online optical store. Article Source:http://www.articlesbase.com/vision-articles/the-debate-on-lucentis-and-avastin-1310802.html

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Technological Advances in Cataract Surgery

The last decade has seen many improvements in all types of eye surgery. More specifically, by 2005 the technological advances in cataract surgery showed great potential for using surgical microincisions. The techniques had, by then, already shown that cataract removal could be accomplished safely and with equal or better outcomes than with older techniques using longer incisions.

Small Incision Cataract Surgery

Since 2005, the development of foldable intraocular lenses (IOL) has made small incision cataract surgery a popular alternative for many patients. “Foldable IOLs” can be folded to fit through the smaller incision, then, unfolded as they are positioned against the muscles.

One type of IOL is the “accommodating lens” used in cataract surgery. This type of lens is held in place with a spring-like hinge nested within the muscle folds that would normally contract and expand the natural crystalline lens, which it replaces. These muscles are now able to contract against this hinge, which bends the attached lens, giving it a more natural ability to refocus the light onto the retina. Crystalens® was the first brand of accommodating IOL. Millions of very satisfied patients have received this lens to correct their cataracts. Several new IOLs are undergoing clinical trials in the U.S. but have not yet received FDA approval.

Other methods of accommodation are delivered with diffractive lenses such as ReSTOR®, a well-known brand that also has given millions clear vision. A new brand of accommodating lens is also available, the Tecnis® Multifocal Foldable Acrylic Intraocular Lens with improved focus in bright and low lighting, faster near and intermediate distance reading and zero spherical aberration.

Benefits of Small Incisions over Longer Incisions

Studies have shown that using small incision cataract surgery has NOT produced any corneal astigmatism due to its location on the cornea, nor has it degraded the corneal optical quality in any way. This is good news because this smaller incision heals faster (in a matter of days), the patient returns home within hours of the surgery, and is comparable in all outcomes to previously established methods.

Other advantages of small incision cataract surgery include the techniques developed to do the surgery through the smaller incision. Smaller tools are used, the moisture seal between the cornea and the iris is not disturbed and stitches are not required, as with longer incisions, yet there is less chance of leakage than with stitches.

Future developments include the use of lasers in cataract removal, but lasers are not used in currently approved procedures for removing cataracts.

For more information about cataract surgery in Monmouth or Ocean Counties, New Jersey please visit the website of Susskind & Almallah Eye Associates, P.A.

Article Source:http://www.articlesbase.com/vision-articles/technological-advances-in-cataract-surgery-1307857.html

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