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Trials & Filings

Lucentis Reinforces Safety, Efficacy

Post-approval studies cover multiple indications

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Novartis released new data for Lucentis in a series of abstracts at the EURETINA congress. Based on meta-analysis of 14 trials and 6504 patients, Lucentis sustained its safety profile. Lucentis is indicated in many countries for the treatment of wet age-related macular degeneration (wet AMD), for visual impairment due to diabetic macular edema (DME), macular edema secondary to branch- and central-retinal vein occlusion (BRVO and CRVO), and choroidal neovascularization secondary to pathologic myopia (myopic CNV).

The Phase III, 12-month RADIANCE trial demonstrated Lucentis superiority to current standard of care and improved mean visual acuity by around 14 letters at one year with a median of two injections in Myopic CNV. In REPAIR, a Phase II, 12-month study, a mean visual acuity gain of 13.8 letters from a low number of injections to month 12 (mean 3.6, median 3) was demonstrated in that indication. The RELIGHT study demonstrated that switching to bimonthly follow-up after initial dosing maintains improvements in vision for patients with DME. Median visual acuity gains of five letters.

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