Regeneron's EYLEA HD posts Phase 3b safety results; dupilumab keloid study completes

Two items surfaced this week involving Regeneron-associated studies, one with posted safety data and one marking study completion.

• Regeneron's Phase 3b "ELARA" study examined how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks¹ in patients with nAMD or DME, with enrollment of 1126 participants (actual)¹. Through week 24, treatment-emergent adverse events were reported in 17.0% of nAMD participants and 22.3% of DME participants, with serious TEAEs affecting 34 of 625 nAMD participants and 40 of 501 DME participants.
• A Phase 2 open-label study testing dupilumab (Dupixent) in keloid patients, sponsored by Beth Israel Deaconess Medical Center with Regeneron as a collaborator, has reached completed status after enrolling 20 participants². The researchers set out to test whether the drug could reduce keloid size and symptoms and help patients' quality of life, as the study's title describes an Open-label Proof of Concept Study Regarding the Efficacy and Safety of Dupilumab in the Treatment of Keloids², using the Patient and Observer Scar Assessment Scale as its primary outcome measure.