- 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 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
FDA accepts NDA for Sydnexis's low-dose atropine for pediatric myopia
Once-daily drop features unique establishing excipient to avoid rapid atropine degradation; may become first eye drop with 3-year shelf-life.
Pipeline
Opus Genetics receives Fast Track designation, reports phase 3 updates for phentolamine solution
VEGA-3 and LYNX-2 trials report completion and near completion of patient enrollment evaluating POS 0.75% for presbyopia and visual loss in low light conditions associated with keratorefractive surgery, respectively.
Pipeline
FDA accepts Aldeyra's reproxalap DED NDA resubmission
With a new PDUFA data set for April 2024, the company also announced expansions to its option agreement with AbbVie.
Pipeline
Aldeyra resubmits reproxalap NDA for DED
Submission includes recent data from phase 3 dry eye chamber trial supporting the candidate’s acute and chronic activity in reducing symptoms.
Products
FDA sends warning letter to Regener-Eyes for cGMP violations, unapproved new drugs
Agency notes significant and unaddressed concerns pertaining to company’s Regener-Eyes PRO and LITE products following June 2023 inspection.
Pipeline
FDA OKs Palatin's phase 3 DED trials on melanocortin agonist
Patient enrollment for MELODY-2 and MELODY-3 studies is expected to start Q4 2024.
Pipeline