Despite the rejection, analysts saw Regeneron’s use of an alternate filler for Eylea HD as a positive development, with BMO Capital Markets noting that this could signal the end of manufacturing ...

EYLEA HD has shown impressive durable visual improvements and rapid and resilient fluid control with a safety profile comparable to EYLEA Extended dosing intervals with EYLEA HD have the potential to ...

Three new post-hoc analyses highlight EYLEA HD rapid and sustained fluid control and consistent safety profile over two years in patients with wet age-related macular degeneration (wAMD) New indirect ...

Approval based on the pivotal PULSAR and PHOTON trials in which EYLEA ® HD demonstrated clinically equivalent vision gains to EYLEA (aflibercept) Injection 2 mg that were maintained with fewer ...

4D Molecular Therapeutics has sold the Asia-Pacific rights to its eye gene therapy to Otsuka Pharmaceutical, securing $85 ...

Regeneron is planning to re-apply to the FDA with a new pre-filled syringe manufacturing filler in January 2026.

Supplementary biologics license application planned for submission to the U.S. Food and Drug Administration in the first quarter of 2025 “All currently FDA-approved anti-VEGF therapies for retinal ...

If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated ...

Long-term data and subgroup analyses from pivotal EYLEA HD clinical program highlight durability of visual improvements and consistent safety across extended dosing intervals and patient ...

TARRYTOWN, N.Y., March 08, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced The Lancet published one-year results from the pivotal PULSAR and PHOTON trials for ...