- 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 approves Amneal's bimatoprost 0.01% generic
Generic version of Allergan’s LUMIGAN is indicated for reducing elevated IOP in glaucoma and ocular hypertensive patients.
Legal
FDA issues Scope Health warning letter over OPTASE ophthalmic products
Agency names Allegro, MGD Advanced, and Dry Eye Intense eye drops among products identified as unapproved new drugs and misbranded.
Products
FDA sends warning letters to three eye drop manufacturers
Agency identifies iVIZIA eye drops, Revitalize Energizing Eye Drops, and FOCUS PI Eye Drops as unapproved new drugs and misbranded products.
Products
FDA approves LENZ Therapeutics' VIZZ for presbyopia
LNZ100, now VIZZ, is the first and only FDA-approved aceclidine-based eye drop for the treatment of presbyopia in adults.
Pipeline
FDA accepts Aldeyra's resubmitted reproxalap NDA
Company hopes third submission of the DED application is the charm for achieving marketing approval by a Dec. 26, 2025 PDUFA date.
Products
Regener-Eyes ends recall of remaining older product inventory
Company previously issued voluntary recall for older bottles in December 2024 following the launch of updated bottles with backflow prevention technology.
Pipeline
Aldeyra resubmits reproxalap NDA for dry eye (again)
Company includes new phase 3 dry eye crossover data in updated submission package; an FDA acknowledgement response is expected within 30 days.
Products
FDA approves Amneal's prednisolone acetate ophthalmic suspension
Referencing Allergan's Pred Forte, this 1% concentrated drop is expected to hit the U.S. market by Q3 2025.
Pipeline
FDA clears IND for Zhaoke Ophthalmology's CsA ophthalmic gel
Clearance paves the way for a new phase 3 trial to evaluate CsA 0.05% for its safety and efficacy among moderate-to-severe DED patients—with plans for an eventual NDA submission.
Pipeline
FDA accepts Tenpoint's Brimochol PF NDA for presbyopia
Fixed-dose-combo eye drop of brimonidine tartrate and carbachol has demonstrated a statistically significant reduction in pupil size up to 10 hours; PDUFA date set for January.
Products