Article

ISTA submits sNDA for once-daily bromfenac

ISTA Pharmaceuticals Inc. has submitted a supplemental new drug application to the FDA for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery.

Irvine, CA

-ISTA Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the FDA for bromfenac ophthalmic solution dosed once-daily as a treatment for ocular inflammation and pain following cataract surgery.

The company markets a 0.09% bromfenac eye drop (Xibrom) for twice-daily use beginning 24 hours after cataract surgery. If the new dosing is approved, ISTA plans to market the once-daily topical non-steroidal anti-inflammatory compound under a different brand name (XiDay).

The company expects the review to be completed in about 6 months.

Newsletter

Don’t miss out—get Ophthalmology Times updates on the latest clinical advancements and expert interviews, straight to your inbox.

Related Videos
(Image credit: Ophthalmology Times) NeuroOp Guru: Using OCT to forecast outcomes in ethambutol optic neuropathy
(Image credit: Ophthalmology Times) Inside NYEE’s new refractive solutions center with Kira Manusis, MD
(Image credit: Ophthalmology Times) Dilsher Dhoot, MD, on the evolution of geographic atrophy therapy: where are we now?
(Image credit: Ophthalmology Times Europe) Anat Loewenstein, MD, shares insights on the real-world results of remote retinal imaging
(Image credit: Ophthalmology Times) Two-wavelength autofluorescence for macular xanthophyll carotenoids with Christine Curcio, PhD
(Image credit: Ophthalmology Times) FLIO and the brain: Making the invisible visible with Robert Sergott, MD
(Image credit: Ophthalmology Times) Structure-function correlates using high-res OCT images with Karl Csaky, MD, PhD
(Image credit: Ophthalmology Times) SriniVas Sadda, MD, on high-res OCT of atrophic and precursor lesions in AMD
(Image credit: Ophthalmology Times) Christine Curcio, PhD, shares histology update supporting review software and revised nomenclature for <3 μm OCT
© 2025 MJH Life Sciences

All rights reserved.