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Bausch + Lomb's glaucoma neuroprotective candidate fails Phase II primary endpoint

Bausch + Lomb's glaucoma neuroprotective candidate fails Phase II primary endpoint

Bausch + Lomb's BL1107 glaucoma Phase II trial failed to replicate earlier visual function signals in primary open-angle glaucoma, a setback that closes the topical eye drop program but leaves the company's broader neuroprotective ambitions intact through a pivot to a sustained-release implant for geographic atrophy.

The Phase II study (NCT07168902) enrolled 159 adults with primary open-angle glaucoma or ocular hypertension in a randomized, double-masked, three-arm, parallel-group design comparing BL1107 against timolol maleate 0.5%. The primary endpoint — change from baseline in visual field mean deviation at Day 28 — was not met, and key secondary endpoints assessing visual function, including low-luminance best-corrected visual acuity responder rates, were also not achieved. One secondary endpoint was met: a reduction in intraocular pressure at Day 28, which the company described as evidence of ocular target engagement. No quantitative data were disclosed. The safety profile was consistent with prior BL1107 clinical experience, with no new safety signals identified.

The trial was designed to confirm visual function improvements observed in a smaller Phase I/IIa study following 28 days of topical administration. The Phase II enrolled 159 patients, and the data represent a complete topline readout rather than an interim analysis. No efficacy data by treatment arm were reported, and the company did not disclose individual dose levels for BL1107 across the three study arms.

Bausch + Lomb (NYSE/TSX: BLCO), headquartered in Vaughan, Ontario, acquired Whitecap Biosciences in 2025 primarily to develop BL1107 — originally designated WB007 — as a sustained-release implant for geographic atrophy, a late-stage complication of age-related macular degeneration that causes progressive central vision loss. The glaucoma neuroprotection program was pursued in parallel as a secondary strategic objective. Following the Phase II failure, the company said it will discontinue the topical eye drop program entirely and focus on the GA implant, with clinical trials anticipated to begin in 2028 in collaboration with Ripple Therapeutics, whose polymer-free controlled-release technology underpins the delivery platform.

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BL1107's mechanism of action has not been fully disclosed publicly, though the asset is characterized as a small molecule with alpha-2 adrenergic agonist properties, a class with established IOP-lowering and proposed neuroprotective effects in glaucoma. BL1107's failure to replicate even a directional visual field signal at Day 28 in a large, adequately powered cohort raises questions about whether the earlier Phase I/IIa findings reflected a true treatment effect or were subject to small-sample variability. For IOP reduction specifically, netarsudil 0.02% (Rhopressa), a Rho kinase inhibitor, achieved non-inferior IOP lowering to twice-daily timolol in the pivotal ROCKET program, illustrating the competitive standard BL1107 faced on that secondary measure. Cross-trial comparisons are limited by differences in study design, duration, and patient populations.

The outcome is consistent with a broader pattern in glaucoma neuroprotection research, where preclinical and small-study signals have repeatedly failed to translate into statistically significant visual field benefits in larger trials. The field has yet to produce an approved neuroprotective agent, and BL1107's Phase II result does not alter that landscape. Bausch + Lomb's decision to discontinue the topical program while preserving the sustained-release implant reflects a calculation that the GA opportunity — a larger and less crowded indication — justifies continued investment in the molecule through a different delivery format, even absent confirmatory glaucoma efficacy data.


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