Regeneron Pharmaceuticals (NSDQ:REGN) announced data supporting the use of its EYLEA injection in NPDR patients. Protocol W, a NIH-sponsored trial to evaluate the EYLEA (aflibercept) injection in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME), had its initial results published in JAMA Ophthalmology. At two years, the primary […]
Regeneron
Regeneron touts one-year diabetic retinopathy data for Eylea
Regeneron Pharmaceuticals (NSDQ:REGN) touted one-year results from a Phase III trial of its Eylea aflibercept injection in people with moderately severe to severe non-proliferative diabetic retinopathy. The primary endpoint of the two-year Panorama trial is the proportion of patients who experience a two-step or greater improvement in the ‘diabetic retinopathy severity scale.’ Of the 133 people […]
Clearside Biomedical’s combo therapy fails in Ph3 retinal vein occlusion trial
Clearside Biomedical (NSDQ:CLSD) said today that its lead drug, in combination with Regeneron‘s (NSDQ:REGN) Eylea, failed in a phase III retinal vein occlusion trial. The trial’s primary endpoint was the proportion of patients in the combination treatment arm, compared to the group receiving just intravitreal Eylea, that experienced improvements in best corrected visual acuity after eight weeks. […]
FDA to review Regeneron’s Eylea for diabetic retinopathy
Regeneron Pharmaceuticals (NSDQ:REGN) said today that the FDA plans to review the supplemental biologics license application for Regeneron’s Eylea aflibercept injection for the treatment of diabetic retinopathy. The U.S. agency plans to make a decision about the blockbuster drug by May 13, 2019. Regeneron’s Eylea is dosed using a two-milligram intravitreal injection and is already approved […]
Bayer wins second approval in China for Eylea eye drug
Bayer (ETR:BAYN) said today that its eye drug, Eyelea, was approved by the Chinese authorities to treat patients with wet age-related macular degeneration. The pharmaceutical giant’s aflibercept injection is already cleared in China to treat visual impairment due to diabetic macular edema. Age-related macular degeneration accounts for 8.7% of all blindness, according to Bayer – that’s […]
Regeneron, Sanofi strike pricing deal with Express Scripts for cholesterol drug
Regeneron Pharmaceuticals (NSDQ:REGN) and its partner, Sanofi (NYSE:SNY), have agreed to lower the cost for its cholesterol drug, Praluent, for Express Scripts (NSDQ:ESRX) in exchange for an exclusive spot on the pharmacy benefit manager’s national formulary. The agreement, effective July 1, is designed to broaden patient access to the injectable medicine and lower out-of-pocket costs for eligible […]
Regeneron unveils topline Ph3 diabetic retinopathy data for blockbuster eye drug
Regeneron Pharmaceuticals‘ (NSDQ:REGN) eye drug Eylea brought in nearly $6 billion in sales last year. In an attempt to keep the injectable drug in a league of its own, the biotech plans to apply for a new indication with the FDA this year. The company today announced results from a Phase III trial evaluating Eylea in […]
Eylea wins approval in China for diabetic macular edema
Bayer (ETR:BAYN) said today that the Chinese State Food and Drug Administration has approved Eylea to treat patients who have visual impairment due to diabetic macular edema. It’s the first indication for Eylea to be approved by the Chinese regulatory body. The injectable eye drug is sold by Regeneron (NSDQ:REGN) in the U.S. and has been approved […]
Mylan, Momenta take aim at Regeneron’s Eylea with biosimilar
Momenta Pharmaceuticals (NSDQ:MNTA) and Mylan (NSDQ:MYL) announced yesterday that they plan to launch a pivotal trial in the first half of 2018 for a proposed biosimilar to Regeneron‘s (NSDQ:REGN) blockbuster drug, Eylea. Eylea, a VEGF-inhibitor designed to treat wet age-related macular degeneration and diabetic macular edema, has little competition on today’s market. The drug brought in […]
How this biotech plans to go up against big pharma with its eye disease products
Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena – after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to bring eye disease products to the patients that big pharma’s drugs have left out. “There’s […]
