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    The future of anti-VEGF

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    In May 2013, the Committee for Medicinal Products for Human Use (CHMP) recommended that Lucentis (ranibizumab; Novartis, Basel, Switzerland) be licensed to treat visual impairment associated with choroidal neovascularization secondary to pathologic myopia (myopic CNV),1 and the approval — based on the outcome of the Phase III RADIANCE study2 — was duly granted.3 This is the fourth indication for the anti-VEGF agent, which was launched in 2006 and is also licensed for the treatment of wet age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME) and for visual impairment due to macular oedema secondary to central or branch retinal vein occlusion (RVO).

    After the positive opinion was issued, Novartis hosted a webex meeting at the European Society of Ophthalmology (SOE) 2013 in Copenhagen, Denmark, on the role of long-term anti-VEGF therapy. This briefing examined the data that led to the recommendation, discussed the outcomes of the ranibizumab versus bevacizumab head-to-head trials and surveyed possible future options for AMD treatment. Here, we give a brief overview of the outcomes of this meeting.

    RADIANCE data

    Prior to the approval of Lucentis in this indication, vision loss due to myopic CNV represented a significant unmet medical need. Pathologic myopia affects 1–3% of the population worldwide,4,5 often presenting in adults under 50 years of age, and the most common vision threatening complication of pathologic myopia is CNV.6,7 Because the long-term prognosis of patients with untreated myopic CNV is poor (with approximately 90% of affected patients developing severe vision loss after five years8) and the previous standard of care [photodynamic therapy with Visudyne (verteporfin; Valeant Pharmaceuticals)] only stabilizing (rather than improving) vision, the loss of vision associated with myopic CNV can have a profound impact on productivity, financial status, career expectations and quality of life in working-age individuals.9

    The RADIANCE study2 examined 227 patients randomized 2:2:1 to treatment with Lucentis [based on stability of visual acuity (VA); n = 105], Lucentis (based on disease activity; n = 116) or Visudyne PDT (n = 55). The primary endpoint (superiority of 0.5 mg Lucentis vs Visudyne PDT as assessed by mean average change in BCVA from baseline) was assessed at month 3; after this point, patients in the Visudyne group became eligible for treatment with Lucentis.


    Figure 1: Change in best-corrected visual acuity in the RADIANCE study.10
    The study achieved its primary efficacy endpoint, patients treated with Lucentis (after a median of 2.0 injections) had a mean VA improvement of up to 14 letters from baseline. Mean gains in best corrected visual acuity from baseline for Lucentis (group 1), Lucentis (group 2) and Visudyne were 12.1, 12.5 and 1.4 letters, respectively, at 3 months and 13.8, 14.4 and 9.3 letters, respectively, at one year (Figure 1).10 During the first year, over 60% of patients treated with Lucentis needed no further injections after 6 months;11 more than 70% of patients treated with Lucentis experienced a reduction in CNV leakage (assessed by OCT and/or FA) and intraretinal oedema, with central retinal thickness being significantly reduced from as early as month one.10 There were no endophthalmitis cases reported, in keeping with the treatment's well established safety profile.3

    "The natural history of this disease is that there's a decline in vision over time, but now we've seen, in this large pivotal controlled trial, that ranibizumab has provided rapid visual improvements in patients with myopic CNV," explained the Medical Director of Novartis Ophthalmology during the meeting.

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    Victoria Farrell
    Victoria Farrell is a freelance writer and the former associate editor of Ophthalmology Times Europe, and moderator of the ...

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