The Drug Regulatory Authority, Food and Drug Administration (FDA), have approved the Swiss Pharma giant Roche to market its product Lucentis, to treat diabetes-induced macular edema. Lucentis can be administered as an intra-vitreal injection, once in 28 days that can prevent macular edema and vision loss in diabetic individuals.
Previously, Lucentis was approved to treat wet-type/neovascular age-related macular degeneration and macular edema as a result of retinal vein occlusion (RVO).
Roche conducted two clinical studies to ascertain the safety and efficacy of Lucentis against diabetes macular edema. In a double-blind, randomized, case-controlled study, 579 patients were assigned to receive conventional treatment or placebo. After the study period, the Lucentis treatment group continue to receive the same dose, once in 28 days.
The Lucentis received group were analyzed using fluorescein angiography and Amsler grid and results showed that they significantly gained vision in secondary end points, maintained visual acuity and better eyesight than patients who underwent photodynamic therapy but not participated in this study. In Lucentis treated patients, nearly 34 to 45% of study participants who received 0.3 mg of Lucentis gained three to fifteen lines of accurate vision of in Amsler grid without distortion or waves. However, in patients who received 0.5 mg of Lucentis, no significant additional benefits were reported.
In a press meet, Roche informed that the Lucentis is the first and only drug that received FDA approval for treatment of diabetes-induced macular edema and Lucentis can fend off the need for laser surgery, which can achieve limited success.
The adverse events of Lucentis are conjunctival hemorrhage, raised intra-ocular pressure, pain in eyes and presence of vitreous floaters. Lucentis injections should be administered only by Ophthalmologists and patients should be monitored after they received Lucentis treatment.
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