Phase II Data May Be Good Sign For 8mg Aflibercept, But Will Payers Bite?

There are concerns that even with better efficacy and dosing versus Eylea and biosimilars, payers may impose step-edits on Regeneron’s new high-dose version.

Female eye with long eyelashes close up. Closeup shot of female gray - blue colour eye with day makeup. Beauty female eye with curl long eyelashes
Regeneron announced Phase II data for aflibercept 8mg in wet AMD • Source: Shutterstock

Phase II data for Regeneron Pharmaceuticals, Inc.’s high-dose version of aflibercept appear to bode well for a Phase III readout expected later this year and give it a decent shot at competing against other newer drugs for wet age-related macular degeneration (AMD). Still, there is a chance that it could run up against restrictions in insurance coverage, based on concerns that physicians have previously expressed.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Sensory

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

 

The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.

GSK’s Linerixibat GLISTENs In PBC Itching

 

But differences in trial design means it is hard to handicap GSK’s product against Mirum’s volixibat.

Clearside Clears Way For Phase III After Positive CLS-AX Results In Wet AMD

 

The company is developing the drug as a way to reduce injection burden for wet AMD patients and plans to meet with the US FDA early next year to discuss Phase IIb topline results.

More from Therapy Areas

US FDA Expands Label For BMS’s Camzyos Days After Phase III Stumble

 

The agency loosened requirements for echocardiograms and removed contraindications for a number of commonly used drugs.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By 

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Lilly Scores With Orforglipron In Diabetes, Generating Excitement For Obesity

 

The company announced positive topline results for the oral GLP-1 drug in type 2 diabetes that beat expectations.