- 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 approves RYZUMVI for presbyopia
Phentolamine ophthalmic solution 0.75% now has two indications in the U.S.; commercial launch timeframe is unknown as Viatris seeks a partner.
Pipeline
Aldeyra to formally appeal third reproxalap CRL
Company to submit a formal dispute resolution request following Type A and D meetings with FDA over the investigational DED drop.
Pipeline
FDA accepts Nicox's NDA for IOP-lowering glaucoma drop
PDUFA target action date of April 30, 2027, is set for the newly-renamed K-911, a nitric oxide-donating bimatoprost formulation.
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