Friday, 6 February 2015

New FDA Clearance for Ranibizumab for Diabetic Retinopathy with DME

     The USFDA has expanded sate use of Ranibizumab for diabetic retinopathy ane Diabetic Macular Edema (DME) treatment. Diabetes is one of the deadly disease that affecting millions of people every year world wide. In this disease the sugar levels of blood will changes time to time with our order. The patient looses body sugars in urine which makes fall down of sugar levels.

    At the time of eating body sugar levels will increases suddenly which damages body organs. Diabetic patients are more prone to organ damages. The main organ is eye. Several diabetic patients are suffering with diabetic retinopathy which impairs vision. So it needs proper treatment. Organ failure chances will increase with age. It is the most common diabetic eye disease and is leading cause of blindness in adults in US.
Diabetic retinopathy

   The present drug Ranibizumab is the first significant therapy to treat diabetic retinopathy and diabetic macular edema.

Safety and Efficacy studies of Ranibizumab:
   This profile is obtained by 2 clinical studies involving 759 participants who were treaed and followed for 3 years. In the two studies, treatment with Ranibizumabled to significant improvement in severity of DME and diabetic retinopathy when compared with the patients who does not receiving the drug.

Side effects:
1. Bleeding of conjuctiva
2. Eye pain
3. Floaters
4. Increased IOP(Intra Occular Pressure)
5. Endophthalmitis and retinal detatchment (Serious)


    Previously FDA had approved ranibizumab to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula result in blurred vision. Recently FDA granted the Ranibizumab for diabetic retinopathy with DME and reviewed this new use for the drug under the agency's priority review program, which provides for an expedited review of drugs. This drug provides safe and effective treatment in serious condition.

Route of administration:
Ranibizumab is administered by IV injection once monthly.

Other uses of Ranibizumab:
It is also approved for the treatment of neovascular (wet) age related macular degeneratin in US.



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