- Tags: FDA
Products
FDA initiates nationwide recall of 2.5M prednisolone acetate eye drops
Federal agency warns that Lupin’s generic of the prescription-based Pred Forte may have the presence of a foreign substance in its formulation.
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 recalls over 39K bottles of CLEAR EYES Maximum Itchy Relief drops
Federal agency added Class II classification last week after identifying the potential risk for sterility issues with the OTC product.
Products
FDA recalls nearly 12M Rohto cooling eye drop products
Agency classifies nationwide Class II recall after identifying several products sold under the Rohto name connected to a potential risk for sterility issues.
Pipeline
FDA forms advisory committee to review Sydnexis's low-dose atropine
Federal agency to discuss phase 3 clinical data supporting SYD-101 for the treatment of pediatric progressive myopia following NDA rejection.
Pipeline
Kowa submits NDA for NCX 470, a IOP-lowering glaucoma drop
Pending FDA review, Nicox’s NO-donating bimatoprost formulation could receive approval and commercially launch by the end of 2027.
Pipeline
OKYO's urcosimod gets FDA nod, moves to global phase 3 trial for NCP
Positive Type D meeting feedback supports topical therapeutic’s continued path toward becoming the first approved treatment for neuropathic corneal pain.
Pipeline
FDA grants TearSolutions' NK peptide therapy two FDA designations
Investigational eye drop acts as a replacement for lacritin by restoring homeostasis to the ocular surface; phase 2 trial initiation is underway.
Products
FDA issues nationwide voluntary recall for over 3M eye drop bottles
Federal agency identifies eight types of generic eye drops sold under store-brand names connected to potential risk for sterility issues.
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