Lucentis于2006年上市，已获FDA批准的3个适应症分别为：糖尿病性黄斑水肿（DME，2006年）、视网膜静脉阻塞继发黄斑水肿（RVO-ME，2010年）和湿性年龄相关性黄斑变性（wet-AMD，2012）。此次糖尿病性视网膜病变（DR），标志着Lucentis在美国的第四个适应症，在相关临床试验中，Lucentis不仅显著改善了糖尿病性黄斑水肿（DME）患者的视力，同时也使糖尿病性视网膜病变（DR）的损伤程度得到了临床意义的显著改善。
目前，在眼科治疗领域，拜耳眼科药物Eylea正与罗氏Lucentis展开着激烈的竞争。Eylea于2011年底上市，尽管晚了Lucentis几年，但该药上市以来发展势头迅猛，适应症个数及全球销售一再刷新，并连续数次超过业界预期，在相关疾病领域已对罗氏Lucentis形成了严峻的挑战，包括视网膜静脉阻塞继发黄斑水肿（RVO-ME）和糖尿病性黄斑水肿（DME）。去年10月，在一项独立疗效比较研究中，治疗糖尿病性黄斑水肿（DME）时，Eylea疗效击败Lucentis和Avastin，该项研究使得Eylea在DME领域更具影响力。
此次，Lucentis率先拿下糖尿病性视网膜病变（DR）适应症，也标志着对Eylea强有力的反击。不过，Eylea也在步步逼近，FDA目前正在审查Eylea的DR适应症申请，该药于去年9月和12月也收获了FDA的突破性疗法认定和优先审查资格。这也意味着罗氏万不可掉以轻心，须抓住首发优势，竭尽所能在糖尿病性视网膜病变（DR）领域快速抢占市场。
另一方面，当前肿瘤治疗领域竞争异常激烈，尤其是PD-1/PD-L1抑制剂和CAR-T细胞疗法在相关临床取得巨大成功的背景下，作为肿瘤领域的巨头，罗氏面对的挑战可想而知。业界认为，Lucentis作为罗氏最成功的非肿瘤类药物，将在接下来的2015年，肩负更重要的使命。
关于Lucentis：
Lucentis是一种人源化的治疗性抗体片段，旨在阻断所有生物活性形式的血管内皮细胞生长因子A（VEGF-A），该因子的水平在湿性AMD和其他眼科疾病（如糖尿病性黄斑水肿（DME）、视网膜静脉阻塞（RVO））升高。Lucentis于2006年上市，由罗氏（Roche）旗下基因泰克（Genentech）和诺华合作开发，罗氏拥有Lucentis在美国的商业化权利，诺华则拥有该药在美国以外国家和地区的独家权利。（生物谷Bioon.com）
英文原文：FDA approves Roche’s Lucentis (ranibizumab injection) for treatment of diabetic retinopathy in people with diabetic macular edema
-First eye medicine approved for treatment of diabetic retinopathy with diabetic macular edema
-Granted Breakthrough Therapy Designation and Priority Review by FDA
-Diabetic macular edema can occur at any stage of diabetic retinopathy, a leading cause of blindness in American adults.1
-Fourth Lucentis indication for treatment of serious eye diseases since 2006
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) approved Lucentis? (ranibizumab injection) for the treatment of diabetic retinopathy (DR), in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.
The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials.
“While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “With today's approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision.”
Almost 29 million Americans have diabetes.2 The longer people have diabetes, especially if it is poorly managed, the higher their risk for developing DR. It is caused by elevated blood sugar levels damaging the fine blood vessels of the retina, the light-sensitive tissue at the back of the eye necessary for good vision.
DR with DME is a common diabetic eye disease and a leading cause of blindness in American adults under 55.1 DR with DME can lead to conditions that threaten vision.
The FDA designates Breakthrough Therapy to a medicine if it is intended to treat a serious or life-threatening disease and if preliminary clinical research suggests it may provide substantial improvement on clinically significant endpoints over existing therapies.
The FDA grants Priority Review to medicines that, if approved, would have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
In 2012, Lucentis was the first medicine approved by the FDA for the treatment of DME. Lucentis has also been an important option for patients with wet age-related macular degeneration (wet AMD) since 2006 and macular edema following retinal vein occlusion (RVO) since 2010.
About RISE and RIDE
RISE and RIDE are two identically-designed, parallel, double-masked, sham treatment-controlled trials in 759 patients with DR and DME at baseline who were randomized into three groups to receive monthly treatment with 0.3 mg Lucentis, 0.5 mg Lucentis or sham injection. The primary outcome in RISE and RIDE was visual acuity gain at 24 months for DME patients.
The safety and efficacy of Lucentis for the treatment of DR with DME was assessed over three years in patients with baseline DR severity scores ranging from 10 to 75 in the study eye (on the ETDRS diabetic retinopathy severity scale). Secondary and exploratory outcomes were evaluated at 24 months. At Month 24, a higher proportion of patients had observed a three-step or better improvement of their disease compared to sham, as determined by color fundus photography. The safety in the RISE and RIDE Phase III trials was consistent with previous studies.
In the third year of the studies, patients from the control group had the option to cross over to receive monthly treatment with 0.5 mg Lucentis; patients originally randomized to 0.3 mg or 0.5 mg Lucentis continued to receive the same dose and all patients were followed for 12 additional months. The 0.3 mg dose of Lucentis is approved for both DME and for DR in people with diabetic macular edema.
About Lucentis
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
Lucentis is FDA-approved for the treatment of wet AMD, macular edema following RVO, DME and DR in people with DME. Genentech has conducted eight key clinical trials with Lucentis. The medicine has been studied in 21 clinical trials worldwide in more than 9,080 patients.
Lucentis was developed by Genentech. The company retains commercial rights in the U.S. and Novartis has exclusive commercial rights for the rest of the world.
Outside the U.S., Lucentis is approved in more than 100 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).
