August 28th 2025
FDA issues a complete response letter to Outlook Therapeutics for ONS-5010, citing insufficient evidence of effectiveness for wet AMD treatment.
Regeneron’s sBLA for Eylea HD accepted for priority review by FDA
April 17th 2025The supplemental BLA seeks approval for Eylea HD for both the treatment of macular edema following retinal vein occlusion and for broadening the dosing schedule to include every-4-week dosing across approved indications.
FDA approves ranibizumab for the treatment of diabetic macular edema via continuous delivery implant
February 4th 2025Susvimo 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure, continuously delivering a customized formulation of ranibizumab over time.
US FDA grants Fast Track designation for NPI-001 tablets for treatment of retinitis pigmentosa
January 22nd 2025Preclinical studies evaluating NPI-001 have found that it boosts the endogenous antioxidant glutathione, which stops chemically aggressive oxygen molecules from further damaging retinal cells, according to Nacuity Pharmaceuticals.