- tags:FDA
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 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
Lenz Therapeutics submits NDA for presbyopia eye drop
FDA has 60 days to review LNZ100 (1.75% aceclidine) as a pupil-selective and long-lasting therapeutic option.
Pipeline
Aldeyra to resubmit NDA for reproxalap DED treatment
Company plans to initiate a dry eye chamber trial four months after the FDA voiced concerns over the candidate’s clinical efficacy.
Products
FDA approves clobetasol propionate suspension for postop inflammation and pain
Developed by Formosa with exclusive U.S rights owned by Eyenovia, the novel ophthalmic APP13007 is expected to launch mid-2024.
Products
FDA sends warning letters to 4 eye drop manufacturers, distributors
Agency cited multiple violations for EzriCare, Delsam Pharma, LightEyez, and Amman Pharmaceuticals.
Products
CDC identifies source of multistate bacteria outbreak due to artificial tears
Federal, state, and local investigation uncovers origination of nationwide infections and death.
Products
Generic brimonidine ophthalmic solution launches for IOP reduction
Alembic Pharmaceuticals’ generic formulation is indicated to reduce IOP in patients with OAG and OHT.
Products
FDA approves Lupin's BromSite generic equivalent for postop inflammation and pain
Company is the first-to-file for generic formulation of bromfenac ophthalmic solution, 0.075%.
Pipeline