Lucentis于2006年上市，已獲FDA批準(zhǔn)的3個(gè)適應(yīng)癥分別為：糖尿病性黃斑水腫（DME，2006年）、視網(wǎng)膜靜脈阻塞繼發(fā)黃斑水腫（RVO-ME，2010年）和濕性年齡相關(guān)性黃斑變性（wet-AMD，2012）。此次糖尿病性視網(wǎng)膜病變（DR），標(biāo)志著Lucentis在美國(guó)的第四個(gè)適應(yīng)癥，在相關(guān)臨床試驗(yàn)中，Lucentis不僅顯著改善了糖尿病性黃斑水腫（DME）患者的視力，同時(shí)也使糖尿病性視網(wǎng)膜病變（DR）的損傷程度得到了臨床意義的顯著改善。
目前，在眼科治療領(lǐng)域，拜耳眼科藥物Eylea正與羅氏Lucentis展開(kāi)著激烈的競(jìng)爭(zhēng)。Eylea于2011年底上市，盡管晚了Lucentis幾年，但該藥上市以來(lái)發(fā)展勢(shì)頭迅猛，適應(yīng)癥個(gè)數(shù)及全球銷(xiāo)售一再刷新，并連續(xù)數(shù)次超過(guò)業(yè)界預(yù)期，在相關(guān)疾病領(lǐng)域已對(duì)羅氏Lucentis形成了嚴(yán)峻的挑戰(zhàn)，包括視網(wǎng)膜靜脈阻塞繼發(fā)黃斑水腫（RVO-ME）和糖尿病性黃斑水腫（DME）。去年10月，在一項(xiàng)獨(dú)立療效比較研究中，治療糖尿病性黃斑水腫（DME）時(shí)，Eylea療效擊敗Lucentis和Avastin，該項(xiàng)研究使得Eylea在DME領(lǐng)域更具影響力。
此次，Lucentis率先拿下糖尿病性視網(wǎng)膜病變（DR）適應(yīng)癥，也標(biāo)志著對(duì)Eylea強(qiáng)有力的反擊。不過(guò)，Eylea也在步步逼近，F(xiàn)DA目前正在審查Eylea的DR適應(yīng)癥申請(qǐng)，該藥于去年9月和12月也收獲了FDA的突破性療法認(rèn)定和優(yōu)先審查資格。這也意味著羅氏萬(wàn)不可掉以輕心，須抓住首發(fā)優(yōu)勢(shì)，竭盡所能在糖尿病性視網(wǎng)膜病變（DR）領(lǐng)域快速搶占市場(chǎng)。
另一方面，當(dāng)前腫瘤治療領(lǐng)域競(jìng)爭(zhēng)異常激烈，尤其是PD-1/PD-L1抑制劑和CAR-T細(xì)胞療法在相關(guān)臨床取得巨大成功的背景下，作為腫瘤領(lǐng)域的巨頭，羅氏面對(duì)的挑戰(zhàn)可想而知。業(yè)界認(rèn)為，Lucentis作為羅氏最成功的非腫瘤類(lèi)藥物，將在接下來(lái)的2015年，肩負(fù)更重要的使命。
關(guān)于Lucentis：
Lucentis是一種人源化的治療性抗體片段，旨在阻斷所有生物活性形式的血管內(nèi)皮細(xì)胞生長(zhǎng)因子A（VEGF-A），該因子的水平在濕性AMD和其他眼科疾?。ㄈ缣悄虿⌒渣S斑水腫（DME）、視網(wǎng)膜靜脈阻塞（RVO））升高。Lucentis于2006年上市，由羅氏（Roche）旗下基因泰克（Genentech）和諾華合作開(kāi)發(fā)，羅氏擁有Lucentis在美國(guó)的商業(yè)化權(quán)利，諾華則擁有該藥在美國(guó)以外國(guó)家和地區(qū)的獨(dú)家權(quán)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).
