- 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.
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
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.
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.
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.
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.
Pipeline
FDA grants Fast Track designation to OKYO Pharma's NCP therapeutic
New status gives urcosimod an expedited pathway toward potential market approval as first approved treatment for this patient base.
Products
FDA grants ANDA approval to olopatadine hydrochloride for ocular allergy relief
Generic of Alcon’s Pataday Once Daily Relief is intended for use as an antihistamine to treat itchy eyes.Pipeline
Tenpoint submits NDA for Brimochol PF for presbyopia
The FDA begins a 60-day review period to determine if the submission for the pupil-modulating eye drop is acceptable.
Pipeline
FDA rejects Aldeyra's reproxalap NDA for a second time
Agency states the candidate failed to demonstrate efficacy in treating ocular symptoms associated with dry eyes; company plans for a third submission.
Pipeline
OKYO Pharma seeks Fast Track designation for NCP candidate
Designation would give urcosimod (formerly OK-101) an expedited pathway to potentially become the first approved treatment for this orphan disease.
Pipeline