Ophthalmic Solution

The FDA granted fast track designation to phentolamine ophthalmic solution 0.75% to treat significant chronic night driving impairment in patients who have undergone keratorefractive surgery.

After receiving a warning letter from the FDA on Aug. 16 citing “significant violations” related to two Regener-Eyes ophthalmic products, the company has implemented several improvements to address the concerns.

LENZ Therapeutics has submitted a new drug application to the FDA for LNZ100, a preservative-free, once-daily aceclidine-based ophthalmic solution designed to treat presbyopia, the company announced in a press release.

The FDA has released a revised draft guidance discussing quality considerations for topical ophthalmic drug products, with the addition of new information related to product sterility and prevention of contamination.

Okyo Pharma announced positive safety and efficacy data from its phase 2 trial of OK-101 ophthalmic solution, a lipid-conjugated chemerin peptide agonist designed to reduce pain and inflammation in patients with dry eye disease.

Ocuphire Pharma has received agreement from the FDA under a special protocol assessment for its LYNX-2 phase 3 trial, a study of phentolamine ophthalmic solution for treatment of reduced visual acuity under low light conditions.

NEW ORLEANS — Twice-daily Cequa improved symptoms of dry eye disease and decreased corneal staining in patients who were still symptomatic or exhibiting signs of disease on current therapy, according to a poster presented at Academy ’23.

LAS VEGAS — The recent FDA approval of Ryzumvi for the reversal of drug-induced mydriasis has created the opportunity to perform more dilated, comprehensive eye exams, according to Paul M. Karpecki, OD, FAAO.

VVN539 ophthalmic solution met its primary endpoints for the treatment of primary open-angle glaucoma or ocular hypertension in a phase 2 study, according to a press release from VivaVision Biotech.

Here it is, at last, the official report of the (not very) momentous (non)randomized (un)controlled clinical trial of “Fauxstasis.”