• Tags: FDA
Alcon voluntarily recalls Systane Lubricant Eye Drops Ultra PF
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.
FDA accepts Lenz Therapeutics’ NDA for presbyopia 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
FDA grants tentative approval for Lupin's Lumify generic eye drops
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.
FDA issues warning against unapproved B+L copycat eye drops
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.
FDA issues new warnings and guidance on OTC 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.
Initial FDA inspection findings of recalled eye drops manufacturer indicate 14 problems
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. 
Amazon receives FDA warning for selling 7 unapproved eye drops
Products

Amazon receives FDA warning for selling 7 unapproved eye drops

Agency cites numerous federal violations and significant public health concerns.
FDA issues warning against use of two MSM eye drops
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.
FDA warns against use of unapproved amniotic fluid eye drops
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.
FDA approves LENZ Therapeutics' VIZZ for presbyopia
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.
FDA accepts Aldeyra's resubmitted reproxalap NDA
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.
Regener-Eyes ends recall of remaining older product inventory
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.
Aldeyra resubmits reproxalap NDA for dry eye (again)
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.
FDA approves Amneal's prednisolone acetate ophthalmic suspension
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.
FDA clears IND for Zhaoke Ophthalmology's CsA ophthalmic gel
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.
FDA accepts Tenpoint's Brimochol PF NDA for presbyopia
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.
FDA approves Alcon's TRYPTYR (acoltremon ophthalmic solution) 0.003% for DED
Products

FDA approves Alcon's TRYPTYR (acoltremon ophthalmic solution) 0.003% for DED

The prescription-based eye drop is the first that stimulates corneal nerves to directly address tear deficiency; company plans for a Q3 2025 U.S. launch.
FDA clears Selagine's immunoglobulin DED drops for phase 2 trial
Pipeline

FDA clears Selagine's immunoglobulin DED drops for phase 2 trial

IND approval supports clinical development and evaluation of the anti-inflammatory and immunomodulatory biologic drug, potentially the first of its kind in the U.S.
Voluntary recall issued for over 75K OTC eyecare products
Products

Voluntary recall issued for over 75K OTC eyecare products

Fearing potential sterility issues, supplier AvKare is asking for ECPS and consumers to discontinue use and return five ophthalmic products distributed nationwide.
Aldeyra to resubmit reproxalap NDA following positive phase 3 data
Pipeline

Aldeyra to resubmit reproxalap NDA following positive phase 3 data

Company reports statistically significant findings supporting the potential DED treatment after last month’s FDA-issued CRL.