DME

Regeneron announced that the FDA has amended the EYLEA HD label after the approval, adding 96-week results from the PULSAR wAMD trial and the PHOTON DME trial.

The phase 2a study looks at retinal vascular diseases, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).

Cases highlight faricimab’s dual VEGF/ANG2 action for severe diabetic macular edema—faster drying, better vision, longer intervals.

The trials are evaluating DURAVYU (vorolanib intravitreal insert) for the treatment of diabetic macular edema (DME).

Real-world nAMD/DME care highlights durable anti-VEGF options and emerging TKIs and gene therapy to cut injection burden, improve vision, and reduce fluid.

Under the US agreement, OPUVIZ (aflibercept-yszy), a biosimilar to Eylea (aflibercept) 2 mg, may launch in January 2027.

A closer look at the science powering next-generation retinal treatments

The primary endpoint of the trial is non-inferiority in the mean change from baseline in best-corrected visual acuity (BCVA) at 52 weeks.

The JADE clinical study enrolled more than 160 patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD).

Strategies for treatment intervals, drug selection, and patient expectations.

A trio of retina specialists recently reviewed the clinical benefits of aflibercept 8 mg, including its extended dosing intervals, improved patient satisfaction, and enhanced treatment outcomes for various conditions.

The company noted that this approval marks Celltrion's first Health Canada–approved biologic product in ophthalmology.

Additionally, the FDA approved a monthly dosing option for some patients who may benefit from resuming this dosing schedule across approved indications.

CoTx-101 is intended for the treatment of retinal vascular diseases, such as wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).

The company describes KSI-101 as a “novel, potent, and high-strength (100 mg/mL) antibody-based investigational therapy with a bispecific mechanism of action targeting both interleukin-6 (IL-6) and vascular endothelial growth factor (VEGF).”

Under the terms of the agreement, 4DMT will grant Otsuka exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases in Japan, China, Australia, and other Asia-Pacific markets.

Emerging anti-VEGF agents offer enhanced durability and anatomic outcomes in retinal disease.

Regeneron faces another FDA setback for Eylea HD due to manufacturing issues, but plans for new facilities signal future production improvements.

DURAVYU is being developed as a potential sustained-delivery treatment for patients suffering from serious retinal diseases.

EYDENZELT is Celltrion's first FDA-approved biologic product in ophthalmology.

EYLUXVI (ALT-L9) is an aflibercept (Eylea) biosimilar from Alteogen, co-developed by its subsidiary, Alteogen Biologics.

A new staging system for diabetic retinopathy and macular edema is essential, integrating advanced imaging techniques for better disease management and patient outcomes.

The company’s lead clinical-stage program, OLN324, is a higher potency, higher molar dose VEGF/Ang2 bispecific antibody currently in phase 1b clinical development for patients with either wAMD or DME.