Date Posted: 02 June 2010
A double blind Phase III trial in 691 patients has reported that 0.5mg Lucentis plus prompt or deferred laser therapy had a significant improvement in BCVA score compared to laser therapy alone (9 vs. 3 letters, p<0.001). The randomized trial, supported by Allergan and Genentech, compared ranibizumab plus prompt or deferred laser with triamcinoclone plus prompt laser for the treatment of diabetic macular edema (DME). As a result, Lucentis may become part of the standard of care for the treatment of DME and become incorporated into national treatment guidelines by the American Academy of Ophthalmology (AAO).
DME is an ocular manifestation of systemic disease (diabetes mellitus) that affects approximately 80% of patients who have had diabetes for 10 years or more. Focal/grid photocoagulation has represented the standard of care for 25 years since benefit was demonstrated in the ETDRS (Early Treatment Diabetic Retinopathy Study). The relatively recent anti-VEGF approach is based on the observation of increased levels of VEGF in the retina and vitreous of diabetic retinopathy patients.
The present trial results, published by the Diabetic Retinopathy Clinical Research Network in the journal Ophthalmology, showed that the 1 year mean change (± std. dev.) in visual acuity from baseline was greater in Lucentis plus prompt laser group (+9±11, p<0.001) and Lucentis plus deferred laser group (+9±12, p<0.001) compared to triamcinoclone plus prompt laser (+4±13, p<0.31) and sham plus prompt laser group (+3±13). From the study, the researchers concluded that, despite some uncommon associations with endophthalmitis, Lucentis should be considered for patients with DME. Professor George Williams of Oakland University suggested that "the Lucentis and laser combination becomes the benchmark by which we will have to judge products such as Illuvien, VEGF Trap-Eye and Lucentis alone" and further described the impressive results as a "game-changer" in the treatment of DME. According to Dr. Steven Pakola, CMO of Thrombogenics Corp., "anybody developing an experimental drug that works on a similar pathway or via a similar mechanism may be dramatically affected in that they now have to go head-to-head with Lucentis".
The development is unlikely to come as too much of a surprise for companies developing anti-VEGF therapies and many such commercial players are likely to have built the efficacy of Lucentis and its (and Avastin's) potential extension in to similar indications (beyond AMD). Consequently, current and future drug applications may well seek to emphasise additional benefits such as longer half-life, less frequent injections, improved patient compliance and others.
no comments posted
Your IP address: 38.107.191.83