New clinical and real world data for Lucentis®
(ranibizumab) presented in over 40 abstracts at this week's EURETINA congress
confirm its transformational and well-established safety profile in four
retinal diseases. Designed for intraocular use, Lucentis is an antibody
fragment with a short systemic half-life and was first launched in Europe in
2007. Lucentis is now 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 abundance and quality of new data presented at EURETINA, in addition to
the real-world long-term experience with Lucentis, speak to the importance of
this anti-VEGF treatment for providing vision gains to patients and affirms
its role as the standard of care in retinal medicine," said Dr Timothy Wright,
Global Head Development, Novartis Pharmaceuticals NVS. "Further to its
transformational patient outcomes in wet AMD, DME, and RVO, Lucentis has now
established its superior efficacy in myopic CNV compared with verteporfin
photodynamic therapy as well."
Lucentis study highlights at the 13th European Society of Retina Specialists
(EURETINA) Congress in Hamburg, Germany include:
Myopic CNV: In the RADIANCE global, Phase III, 12-month study, Lucentis was
superior to current standard of care and improved mean visual acuity by around
14 letters at one year with a median of two injections[1]. [Free paper session
6] 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. Myopic CNV patients treated with Lucentis experienced high
overall treatment satisfaction as measured using the Macular Disease Treatment
Satisfaction Questionnaire. The overall score increased from 55.0 at month 1
to 64.9 at month 12 (p = 0.0001)[4]. [Free paper session 6]
Safety profile of Lucentis: In a meta-analysis of 14 Phase II/III trials and
6504 patients across three Lucentis licensed indications - treatment of adults
with wet AMD, visual impairment due to DME and visual impairment due to
macular edema secondary to BRVO or CRVO - the safety profile of Lucentis was
reported to be consistent with that from individual randomized, controlled
clinical trials[3]. [Free paper session 6]
The overall baseline characteristics of the first cohort of wet AMD patients
included in LUMINOUS, a global long-term study being conducted in the routine
clinical practice setting, were as expected and are representative of patients
from a real-world setting[5]. [Poster session]
DME: It was reported in the pivotal RESTORE trial that baseline visual acuity
and duration of both diabetes and DME are strong predictors of best-corrected
visual acuity (BCVA) changes over 36 months. Patients with a shorter duration
of DME had better visual acuity outcomes, which highlights the requirement for
prompt treatment initiation[2]. [Poster session]
The RELIGHT study demonstrated that switching to bimonthly follow-up after the
initial dosing maintains improvements in vision. Median visual acuity gains of
5 letters, consistent with those from RESTORE and DRCR.net studies, were
achieved with reduced monitoring frequency[6]. [Free paper session 6]
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