Bimatoprost gel matches preserved drops

A new set of glaucoma data is getting attention because it addresses a familiar tradeoff in topical therapy: pressure control versus ocular-surface tolerance. A pooled analysis published in *Clinical Ophthalmology* found that preservative-free bimatoprost 0.01% ophthalmic gel was noninferior to benzalkonium chloride-preserved bimatoprost 0.01% solution in patients with open-angle glaucoma or ocular hypertension. The report was highlighted on June 1 by Optometry Advisor, which said the analysis combined two phase 3 international randomized trials sponsored by Laboratoires Théa. That matters because bimatoprost is a standard prostaglandin analogue, while benzalkonium chloride — usually shortened to BAK — has long been linked to ocular-surface irritation in chronic drop users. The preservative-free version uses a gel vehicle rather than a standard solution, a formulation choice Théa and outside clinicians have said is designed to maintain corneal contact time without relying on BAK to aid penetration. (optometryadvisor.com) ### What exactly did the new comparison show? The pooled analysis included 951 patients with open-angle glaucoma or ocular hypertension, with 468 assigned to preservative-free bimatoprost gel and 483 assigned to preserved bimatoprost solution dosed once nightly for three months. The primary endpoint was change in intraocular pressure, with a noninferiority margin of 1.5 mm Hg. (optometryadvisor.com) At week 12, mean intraocular pressure was similar across the day in both groups: 15.80 versus 15.70 mm Hg at 8 a.m., 15.51 versus 15.39 mm Hg at 10 a.m., and 15.47 versus 15.33 mm Hg at 4 p.m. Mean changes from baseline were also close, at minus 8.90 versus minus 8.98 mm Hg at 8 a.m., minus 8.21 versus minus 8.44 mm Hg at 10 a.m., and minus 7.64 versus minus 7.73 mm Hg at 4 p.m., according to Optometry Advisor’s summary of the paper. (optometryadvisor.com) ### Was this the first signal, or a confirmation? A 2024 phase 3 trial report in the *Journal of Glaucoma* had already shown comparable pressure lowering between preservative-free bimatoprost 0.01% gel and BAK-preserved bimatoprost 0.01% solution over three months. Glaucoma Physician reported that trial enrolled 485 patients and found lower rates of conjunctival hyperemia at weeks 6 and 12 in the preservative-free group. (optometryadvisor.com) The newer pooled analysis appears to extend that finding by combining two pivotal trials: LT4032-301, identified by EudraCT number 2017-000846-23, and LT4032-302, listed on ClinicalTrials.gov as NCT05397600. ClinicalTrials.gov describes NCT05397600 as a completed study comparing unpreserved bimatoprost 0.01% with Lumigan 0.01% in ocular hypertensive or glaucomatous patients. (glaucomaphysician.net) ### Did the preservative-free gel look safer or just equivalent? Week-12 safety measures in the pooled analysis were broadly similar, but several tolerability signals favored the gel. Optometry Advisor reported no significant difference in conjunctival hyperemia, 50.2% versus 55.6%, or corneal staining, 33.3% versus 38.2%, while treatment-emergent adverse events occurred in 23.8% of gel-treated patients and 27.6% of solution-treated patients. (optometryadvisor.com) Subjective symptoms were lower in the preservative-free arm. Irritation or burning was reported in 15.6% of patients on gel versus 23.8% on preserved solution, and itching in 11.7% versus 16.2%, the same report said. In the earlier 2024 phase 3 study, Glaucoma Physician also said eye dryness and irritation favored the preservative-free formulation. (optometryadvisor.com) ### Why does the formulation matter in glaucoma practice? BAK has been associated with ocular-surface damage in long-term glaucoma therapy, and a 2009 review in *Cornea* said preserved antiglaucoma drops are frequently linked with dry eye and other ocular-surface symptoms. A 2013 *Journal of Glaucoma* report also examined whether preservative exposure affected later trabeculectomy outcomes. (optometryadvisor.com) Eydie Miller-Ellis of the University of Pennsylvania’s Scheie Eye Institute said at the 2026 American Glaucoma Society meeting that the goal of the gel formulation was to lower intraocular pressure while minimizing ocular-surface irritation. She said Théa expects the product, to be marketed as Zolymbus, to be available in the U.S. toward the end of 2026. (journals.lww.com) ### What should readers watch next? ClinicalTrials.gov shows NCT05397600 as completed, and the next milestone is regulatory and commercial rather than enrollment. Théa’s U.S. launch timing, cited by Miller-Ellis as late 2026, and any additional peer-reviewed publication details from the pooled analysis will be the next concrete markers to watch. (clinicaltrials.gov) (glaucomaphysician.net)