Drug Approved to Treat Diabetic Retinopathy in Those With Diabetic Macular Edema

On February 6, 2015, the U.S. Food and Drug Administration (FDA) expanded the approved use of eye drug Lucentis (ranibizumab injection) to include treatment of diabetic retinopathy in people who have diabetic macular edema.

More than 5.3 million adults in the United States are estimated to have diabetic retinopathy, which occurs when diabetes damages tiny blood vessels in the eye’s retina (the light-sensitive tissue at the back of the eye). In diabetic macular edema, or DME, fluid leaks into an area in the middle of the retina known as the macula, which is responsible for providing crisp vision and fine detail. The macula swells and vision blurs. DME affects approximately 750,000 Americans and about 10% of people who have diabetic retinopathy.


Lucentis, which is also approved to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema, is administered via a monthly injection into the eye by a health-care professional.

The safety and effectiveness of Lucentis for treating diabetic retinopathy with DME was established through two clinical trials involving 759 people who were treated and followed for three years. The data showed that those who received a monthly injection of 0.3 milligrams of Lucentis had significant improvement in the severity of their diabetic retinopathy at two years compared to those who did not receive Lucentis.

According to Edward Cox, MD, MPH, from the FDA’s Center for Drug Evaluation and Research, “Today’s approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication.”

The most common side effects of Lucentis include bleeding of the conjunctiva (the tissue lining the inside of the eyelids and the white part of the eye), eye pain, floaters (small spots in vision), and increased intraocular pressure (pressure inside the eye). Serious side effects include detached retina and eye infection.

The cost of treatment with Lucentis for diabetic retinopathy in people with DME is $1,170 per 0.3-milligram dose. The manufacturer offers programs to subsidize or eliminate the cost of the drug for people without insurance and those with insurance who meet certain criteria. For more information, visit the Lucentis support page or call (866) LUCENTIS (582-3684).

For more information about Lucentis, see the press releases on the FDA or Roche websites or the Lucentis website.

  • JohnC

    At the cost of the treatment and the possible side effects, I think I’ll pass.

  • carefix

    There is a very simple, inexpensive and effective both preventative and therapy for macular edema which I have been using for several years now. It also effective in wet type AMD.

    The treatment is based on the work of Geoffrey Arden at Kings College in London and was/is recently being trialed under the name CLEOPATRA at Ashford William Harvey Hospital in Kent, UK.

    The method is simply to turn off the electrical currents from the eye’s rods by stimulating them with light at a wavelength at the peak of rod sensitivity which is 498nm (or turquoise to you and me) while you sleep. In fact stimulating in the general area is sufficient so 480 to 520nm wavelength is OK. This has the effect of preventing the onset of edemas and reversing them to some extent after they occur.

    The light level used is quite low. As opposed to the light masks used in the CLEOPATRA trials which are useful for quantified controlled trials I simply used 498nm GU10 form lighbulbs I had made up especially in China. The GU10 spot bulb is simply directed at the bedroom ceiling over my head. It runs from a 12V transformer at under half power but this is more than sufficient and the illumination level could easily be lower. In fact the use of a spot is unecessary and serves only to limit the illumination of my wife next to me. Despite this the entire room is lit up with a pleasing turquoise low level glow. Today alternatives include long strings of LEDS in a flexible clear plastic tube.

    The light level should be at such a level that it will pass the “Arden Hand Test”. To check this turn your head to the darkest side of the room whilst lying on your pillow in bed at night. Close your eyes and after a minute or so move your hand in front of your closed eyes. If you can just see a shadow i.e. just a darkening corresponding to the hand movement then your illumination level is fine. Typically this level is quite low and depends upon eyelid thickness and pigmentation etc. Ideally therefore make sure your light source is adjustable.

    It is important to take supplementary melatonin with this treatment as the light stimulation will reduce your own melatonin production. I would guess 3mg per night.

    After nearly four years post diagnosis a cyst in the right eye did not develop further and is virtually non-existent. A cyst in the left eye which was causing small but significant visual impairment has shrunk. In fact I have not been tested for over a year but can report my vision has improved to the point that with both eyes open I notice no distortion of my vision. I am effectively cured. I have had zero injections or any other medication.

    Different people will respond to this treatment with varying degrees of success. Mine has been very successful because I started very early indeed. The clinical trials are producing good results too.

    Simply put there is a very effective preventative for these two eye conditions. It is also an effective therapy. It is very cheap. You can buy your own system for $20/£15. Basically it is just a light bulb! In a hurry? Get a mains green LED bulb and put it in your bedroom till you can find the more pleasant dimmable turquoise ones.

    Please also note: I am not selling anything!