Breaking News
May 28, 2018 - Antibody removes Alzheimer’s plaques, in mice
May 28, 2018 - Community paramedicine program for older adults reduced number of 911 calls, improved health
May 28, 2018 - AAP: Congress Urged to Act to Prevent Firearm Deaths
May 28, 2018 - Subjective memory may be marker for cognitive decline
May 28, 2018 - Illinois looks at medical marijuana use for opioid dependence
May 28, 2018 - Specific neurons may cause male aggressiveness
May 28, 2018 - New consensus statement outlines evidence-based medical opinion on abusive head trauma
May 28, 2018 - E-Cigarettes Don’t Help Smokers Quit, But Cash Might
May 28, 2018 - New screening tool developed to assess tanning addiction
May 28, 2018 - Unhappy combination of alcohol, anger, and aggressive behavior
May 28, 2018 - Loyola survey identifies significant group of burn patients with elevated PTSD symptoms
May 28, 2018 - Cancer cells co-opt pain-sensing ‘wasabi receptor’ to survive oxidative stress
May 27, 2018 - New way of grouping atoms could herald novel materials, drugs and computers
May 27, 2018 - Less is more? Gene switch for healthy aging found
May 27, 2018 - Breast cancer survivors do not receive recommended level of screening after surgery
May 27, 2018 - Recommendations Developed for Managing Postpartum Pain
May 27, 2018 - Rheumatoid Arthritis (RA) | Arthritis Basics | Arthritis Types | Arthritis
May 27, 2018 - ‘Life support’ for transplant livers better than freezing: study
May 27, 2018 - Tree nut consumption linked to improved type 2 diabetes health
May 27, 2018 - Income and education gap causes racial differences in health behaviors, study shows
May 27, 2018 - Even at ‘Safe’ Levels, Air Pollution Puts Seniors at Risk
May 27, 2018 - Obstructive sleep apnea linked to thinning of calvaria, skull base
May 27, 2018 - Epigem’s Managing Director sets the bar for life sciences industry at VentureFest
May 27, 2018 - CPAP may reduce resting heart rate in prediabetic patients
May 27, 2018 - Study reveals striking disparities in health care access and quality across most nations
May 27, 2018 - The Yogi masters were right—meditation and breathing exercises can sharpen your mind
May 27, 2018 - SLU researcher aims to find solutions for diabetes patients at risk of hypoglycemia
May 27, 2018 - Scientists uncover the cause of insulin resistance in obesity
May 27, 2018 - $2.3 million NIH grant to support new project on oxytocin neurons and social behavior
May 27, 2018 - Less Driving Tied to Lower Cardiovascular Disease Risk
May 27, 2018 - Genetics Home Reference: LMNA-related congenital muscular dystrophy
May 27, 2018 - Long-term psychological study confirms time is the best medicine against homesickness
May 27, 2018 - Study explores if CPAP treatment can improve sexual QOL for sleep apnea patients
May 27, 2018 - Study investigates role played by brain in prosocial behavior
May 27, 2018 - New Guidelines Mean 1 in 3 Adults May Need Blood Pressure Meds
May 27, 2018 - Cerebrospinal Fluid (CSF) Analysis: MedlinePlus Lab Test Information
May 27, 2018 - Kids in tough neighborhoods head to ER more often
May 27, 2018 - Exercise alters brain’s dopamine system to help treat addiction, study finds
May 27, 2018 - Sepsis patients treated and released from ED for outpatient follow-up experience good outcomes
May 27, 2018 - Initiative cuts overuse of tests, treatments for bronchiolitis
May 27, 2018 - Study links ‘sleep spindles’ to memory reactivation
May 27, 2018 - Scientists develop new method to speed up genome evolution of baker’s yeast
May 27, 2018 - Sunscreen pills are fake says FDA
May 27, 2018 - Study finds increasing wealth gap between households of seniors and families with children
May 27, 2018 - Link between tuberculosis and Parkinson’s disease discovered
May 27, 2018 - Doctors call on health authorities for permission to provide stroke patients with life-saving treatment
May 26, 2018 - Couples who eat seafood-rich diet tend to get pregnant faster
May 26, 2018 - NIH summit presents recommendations to accelerate treatment development for Alzheimer’s disease
May 26, 2018 - Medication-related harm found to be common among older adults, but preventable
May 26, 2018 - Lunaphore and Vitro announce partnership to develop ISH protocols for RNA, DNA targets
May 26, 2018 - Cryoablation Efficacious for Cancer Pain, Review Finds
May 26, 2018 - Link between IBD and Parkinson’s might allow doctors to slow down condition
May 26, 2018 - Study finds fewer than 5% of low-income, urban mothers use prenatal vitamins before pregnancy
May 26, 2018 - California hospitals urge moms to favor breast milk over formula
May 26, 2018 - Most concussion patients do not receive follow-up care after hospital discharge, says study
May 26, 2018 - Lifetime risks of developing Alzheimer’s dementia vary by age, gender
May 26, 2018 - Researchers find novel ways to improve participation in clinical research
May 26, 2018 - Researchers develop methods for measuring free-base nicotine levels in e-cigarettes
May 26, 2018 - AHA: Preterm Birth Could Warn of Mom’s Future Heart Risks
May 26, 2018 - Some calories more harmful than others
May 26, 2018 - Study links cell size with commitment to division
May 26, 2018 - Researchers develop new, rapid blood test to detect liver damage
May 26, 2018 - Researchers discover cascade of immune processes linked to poor outcomes in aggressive breast cancer
May 26, 2018 - New research will use mathematics to solve mysteries in cell biology
May 26, 2018 - Proposed National Resilience Strategy to reverse catastrophic increases in ‘deaths of despair’
May 26, 2018 - Mice remain slim on burger diet
May 26, 2018 - BMC receives $13.5 million award to test methods for delivering childhood anxiety treatment
May 26, 2018 - ‘Right to Try Act’ will not benefit terminally-ill patients
May 26, 2018 - Study reveals novel statistical algorithm to identify potential disease genes
May 26, 2018 - Two genes play vital roles in malignant brain cancer
May 26, 2018 - Study explores link between groundwater lithium and diagnoses of bipolar disorder, dementia
May 26, 2018 - Researchers reveal stimulatory effects of myelin on young neural cells
May 26, 2018 - Small part of cellular protein that helps form long-term memories also drives neurodegeneration
May 26, 2018 - Four-legged friends can have heart issues, too
May 26, 2018 - Scientists create small, self-contained spaces inside mammalian cells
May 26, 2018 - Better Social Support Network Protects Black Men Against HIV
May 26, 2018 - National Heart, Lung, and Blood Institute (NHLBI)
May 26, 2018 - Burnout, depression can affect ophthalmology residents, study finds
May 26, 2018 - Latinos and African Americans more likely to experience serious depression than Whites
May 26, 2018 - Data from past epidemic could help improve response to future Ebola outbreaks
FDA Approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy

FDA Approves Genentech’s Lucentis (ranibizumab injection) 0.3 mg Prefilled Syringe for Diabetic Macular Edema and Diabetic Retinopathy

image_pdfDownload PDFimage_print

South San Francisco, CA — March 21, 2018 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved the Lucentis (ranibizumab injection) 0.3 mg prefilled syringe (PFS) as a new method of administering the medicine to treat all forms of diabetic retinopathy. In April 2017, Lucentis 0.3 mg became, and remains, the first and only FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (DME), a complication of the eye disease that causes swelling in the back of the eye. Diabetic retinopathy is the leading cause of blindness among working age adults and affects nearly 7.7 million people in the U.S.1,2 The Lucentis 0.3 mg PFS is now the first syringe prefilled with an anti-vascular endothelial growth factor (VEGF) agent FDA-approved to treat both diabetic retinopathy and DME.

“Diabetic retinopathy is a serious condition that affects millions of people in the U.S.,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Today’s approval of the Lucentis 0.3 mg prefilled syringe reinforces our commitment to advancing therapy for those impacted by this vision-threatening disease.”

The Lucentis 0.3 mg PFS, which is made of borosilicate glass and is packaged in a single-use sterile, sealed tray, allows physicians to eliminate several steps in the preparation and administration process, including disinfecting the vial, attaching a filter needle, drawing the medicine from the vial using the needle, removing the filter needle from the syringe and replacing with an injection needle. With the Lucentis PFS, physicians snap off the syringe cap, attach the injection needle to the syringe and adjust the dose prior to administration.

The Lucentis 0.3 mg PFS is expected to be available in the second quarter of 2018.

The Lucentis 0.5 mg PFS, FDA-approved in October 2016, is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV).

About Diabetic Retinopathy and Diabetic Macular Edema

Diabetic retinopathy is the most common cause of vision loss in people with diabetes, which affects approximately 30 million people in the U.S.3 The longer a person has diabetes, especially if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss. Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause vision loss or distortion when the abnormal vessels leak blood or fluid into the eye.1

Diabetic macular edema (DME), which affects approximately 750,000 people in the U.S., is one of the vision-threatening complications of diabetic retinopathy, in which chronic damage occurs to the fine blood vessels of the retina, the light-sensitive tissue at the back of the eye necessary for good vision.4,5

About Lucentis (ranibizumab injection)

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 patients with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV).

Lucentis was developed by Genentech, a member of the Roche Group. 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 110 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), central retinal vein occlusion (CRVO) and visual impairment due to choroidal neovascularization (CNV).

About Genentech in Ophthalmology

Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases. The company is also investigating platforms for sustained ocular drug delivery.

Genentech’s parent company, Roche, is investigating a bispecific antibody for the treatment of retinal eye diseases.

About Genentech Access Solutions

Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed, regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.4 million patients access the medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

1 U.S. Centers for Disease Control and Prevention. Common Eye Disorders: Diabetic Retinopathy. Available at https://www.cdc.gov/visionhealth/basics/ced/index.html. Accessed February 7, 2018.

2 Prevent Blindness America. Diabetic Retinopathy. Available at http://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html. Accessed February 7, 2018.

3 American Diabetes Association. Statistics About Diabetes. Available at http://www.diabetes.org/diabetes-basics/statistics/ Accessed February 7, 2018.

4 Bressler NM, Varma R, Doan Q, et al. Underuse of the Health Care System by Persons With Diabetes Mellitus and Diabetic Macular Edema in the United States. JAMA Ophthalmology. 2014 Feb;132(2):168-73.

5Bhagat N, Grigorian RA, Tutela A, et al. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009;54(1):1-32.

Source: Genentech

Posted: March 2018

Related Articles:

Lucentis (ranibizumab) FDA Approval History

Tagged with:

About author

Related Articles