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24 Feb 2014

Novartis Shows Continued Commitment in Japan with Lucentis Approval in Fourth Japanese Indication, Diabetic Macular Edema

Lucentis (ranibizumab) has been approved by Japanese regulatory bodies for a fourth indication: the treatment of patients with diabetic macular edema (DME), a leading cause of vision loss among patients with diabetes. Laser therapy, the current standard of care in Japan, has provided stabilization of vision in many patients, but generally does not improve vision. Lucentis is the first licensed therapy to significantly improve vision in Asian patients with visual impairment due to DME.


"Lucentis has previously been shown to be an effective treatment, improving vision loss and vision-related quality of life for patients with DME," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "Now Japanese patients living with DME have access to Lucentis, a drug with an unsurpassed efficacy and safety profile across multiple indications."


Approval of Lucentis was based on results from the REVEAL trial, the first randomized clinical trial specifically designed to assess the efficacy and safety of Lucentis in Asian patients with visual impairment due to DME. In this Phase III trial, 396 patients from six countries, including Japan, were initially treated with monthly injections of 0.5 mg Lucentis, 0.5 mg Lucentis plus laser treatment or laser treatment alone for two months. Treatment was continued for 12 months if stable vision was not reached[1].


Efficacy and safety results from the REVEAL study were similar to other DME trials primarily conducted in Caucasians[2],[3]. At 12 months, REVEAL confirmed the superior efficacy of Lucentis with rapid and sustained visual acuity gains compared with laser therapy. Safety results showed that Lucentis was well tolerated in patients with DME both as monotherapy or when administered together with laser[1].


Diabetic macular edema is a consequence of diabetic retinopathy, the most common diabetic eye complication. DME is characterized by changes in the blood vessels of the retina, which is the light-sensitive layer at the back of the eye. In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment. Visual impairment due to DME affects approximately 1–3% of patients with diabetes, and DME is a leading cause of blindness in the working-age population in most developed countries[4].



[1] Ohji M, et al. Efficacy and safety of ranibizumab 0.5 mg as monotherapy or adjunctive to laser versus laser monotherapy in Asian patients with visual impairment due to diabetic macular edema: 12-month results of the REVEAL study. ARVO 2012 Annual Meeting Abstracts.


[2] Massin P, et al. Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care 2010;33:2399-2405.

[3] Mitchell P, et al. The RESTORE study: ranibizumab monotherapy or combined with laser versus laser monotherapy for diabetic macular edema. Ophthalmology 2011;118:615-625.

[4] Ciulla TA, et al. Diabetic retinopathy and diabetic macular edema. Diabetes Care 2003;26:2653-2664.


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