Lucentis Approved for Diabetic Retinopathy

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Lucentis Approved for Diabetic Retinopathy

FDA Approves Lucentis for Treatment of Diabetic Macular Edema, Randall Wong, M.D.Lucentis is now FDA approved for the treatment of diabetic macular edema (DME). Diabetic macular edema is the most common “complication” of diabetic retinopathy.

Retinal swelling can now be treated by either laser treatment or intravitreal injection. This is the first time we (doctors, that is) have an FDA approved alternative for the treatment of DME.

Laser Not For Everyone

Laser treatment, the gold standard for DME, has been in use for about 30 years and has been the standard of care. Not all patients; however, are great candidates for laser treatment. Either their swelling doesn’t respond to laser treatment, or the areas of leakage can’t be treated without damaging the central vision.

Intravitreal injections are attractive because they treat the disease by a different mechanism.

Lucentis Limits Swelling

The goal of successful treatment for DME is to decrease the amount of swelling.  Laser treatment works by heating the areas of leakage and/or increasing absorption of the abnormal fluid.

Lucentis, and other anti-VEGF medications, are known to work by chemically stopping the leakage of the normal retinal blood vessels.

Lucentis and Laser for Treating DME

Due to the different mechanisms by which the treatments work, it is plausible that both Lucentis and laser treatments can be used to achieve success.  While not usually applied at the same time, both injections and laser treatment are often used in combination over the course of treatment.

What Does This Mean?

Use of Lucentis for diabetic retinopathy is actually not new.

Retina specialists have been using Lucentis and Avastin (both are similar anti-VEGF medications) for several years to treat diabetic macular edema.  Both have been FDA approved for the treatment of other diseases (macular degeneration and cancer, respectively) and have been used “off-label” for the treatment of macular edema.

Off-label use, that is, prescribing a drug for other than the FDA approved treatment is common practice.  FDA approval is necessary for getting a drug to market, but once on the market, other uses may be determined.

While this approval does validate our “off-label” use of the drug, it now allows the manufacturer to market the drug as a treatment for diabetic retinopathy.  Without FDA approval, a company can not advertise or recommend its use for anything other than the intended treatment.

 

Comments
  • Dan September 2, 2012 at 1:31 am

    Dear Doc.
    I take AVASIN injections every four months. Does this news mean that I should go for Lucentis? is AVASTIN FDA approved?
    Many thanks in advance.

    Regards,

    Dan

  • avidresearch (twitter handle) July 14, 2013 at 12:51 pm

    I am a regular reader of your blogs and want to thank you for all the information you share with patients suffering from Ocular diseases. I follow the ophthalmology space very closely, mostly for personal reasons, but occasionally for investment purposes as well. I know you are aware of 2 sustained release steroids, Ozurdex, and Iluvien. The DRCR.net Protocol has left many retinal specialist questioning the benefit of steroids over VEGF treaments. I recognize the protocol used triamcinolone (and not Ozurdex or Iluvien) which failed to differentiate with laser, but at the same time, there is evidence steroids offer benefit to those not responding to VEGF treatments like Lucentis, ie. chronic DME subjects. Do you think Iluvien will find some adoption among the retinal specialists, especially for psuedophakic subjects, if and when it becomes available here in the US?

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