- Tags: FDA
Products
Alcon voluntarily recalls Systane Lubricant Eye Drops Ultra PF
Late last month, the FDA reported a potential risk for fungal contamination associated with one lot of the preservative-free eye drops.
Pipeline
FDA accepts Lenz Therapeutics’ NDA for presbyopia eye drops
PDUFA target action date on LNZ100 (1.75% aceclidine) is set for August 2025
Products
FDA grants tentative approval for Lupin's Lumify generic eye drops
Brimonidine tartrate ophthalmic solution, 0.025% is indicated to treat ocular redness due to minor irritations in the eye.
Products
FDA issues warning against unapproved B+L copycat eye drops
Sample testing has identified bacterial contamination from products falsely marketed as a generic formulation of LUMIFY eye drops.
Products
FDA issues new warnings and guidance on OTC eye drops
Agency updates consumer tips and recommendations after a busy year of product recalls and warnings.
Products
Initial FDA inspection findings of recalled eye drops manufacturer indicate 14 problems
Agency reports unsanitary facility conditions and omitted/falsified contamination and sterility test results, among other violations.
Products
Amazon receives FDA warning for selling 7 unapproved eye drops
Agency cites numerous federal violations and significant public health concerns.
Products
FDA issues warning against use of two MSM eye drops
Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops are at the center of the latest recall.
Legal
FDA warns against use of unapproved amniotic fluid eye drops
Notification follows letters to Regener-Eyes and M2 Biologics for invalidated DED products on the market.
Products
FDA clears Harrow's IND to initiate phase 3 trial on TRIESENCE
Study to kick off in Q1 2026, supporting expansion of corticosteroid’s on-label usage for postop inflammation and pain among all cataract surgery patients.
Pipeline
FDA accepts sNDA of phentolamine 0.75% for presbyopia
Already FDA-approved and commercially available as RYZUMVI, the eye drop has been assigned a PDUFA date of Oct. 17, 2026.
Pipeline
Nicox reports positive pre-NDA FDA meeting for IOP-lowering drop
NO-donating bimatoprost formulation remains on track for a summer 2026 new drug application submission.
Pipeline
FDA clears Cloudbreak Pharma's IND for phase 2 presbyopia drop trials
Clearance green lights advancement of CBT-199, an ophthalmic emulsion with a proprietary, water-free formulation and parasympathomimetic miotic agent.
Products
FDA approves Tenpoint's YUVEZZI as first dual-agent presbyopia drop
First and only combination drop of carbachol and brimonidine tartrate achieves miosis within 30 minutes and lasts up to 10 hours following once-daily dosing.
Products
FDA approves Alembic's difluprednate 0.05% generic
Generic version of Sandoz’s Durezol is indicated for postop pain and inflammation as well as endogenous anterior uveitis.
Products
FDA approves Gland Pharma's OTC Extra Strength Pataday generic
Olopatadine HCl ophthalmic solution 0.7% is indicated to temporarily relieve itchy eyes due to pollen, ragweed, grass, animal hair, and dander for 24 hours.
Pipeline
FDA extends reproxalap's PDUFA to March 2026
Updated target action date applies to Aldeyra’s third NDA submission of the investigational DED eye drop.
Pipeline
Cloudbreak advances vascularized pinguecula eye drop to phase 3 trials
Company’s investigational multi-kinase inhibitor targeting VEGFs and PD-GFRs met phase 2 primary endpoint of conjunctival hyperemia earlier this year
Products
FDA approves Alembic Pharma's loteprednol etabonate and tobramycin ophthalmic suspension
Generic of Bausch + Lomb’s ZYLET for steroid-responsive inflammatory ocular conditions qualifies for 6 months of market exclusivity once commercially launched.
Products