A multinational Phase III clinical trial has demonstrated the superior efficacy and improved tolerability of a novel preservative-free latanoprost eye drop emulsion compared to standard preserved latanoprost for treating open-angle glaucoma and ocular hypertension.
The double-masked, randomized study involving 386 patients across 47 sites showed that the preservative-free formulation achieved the primary endpoint of non-inferiority in intraocular pressure (IOP) reduction. At 12 weeks, the new formulation demonstrated greater IOP lowering at peak measurement with a treatment difference of -0.6 mmHg (p=0.023) compared to preserved latanoprost.
Enhanced Clinical Outcomes
The preservative-free formulation showed particular strength in achieving targeted treatment goals. A significantly higher proportion of patients achieved IOP reduction to ≤18 mmHg at trough measurement (87.6% vs 79.3%, p=0.029). Additionally, 74.5% of patients receiving the new formulation achieved ≥30% IOP reduction compared to 64.0% in the preserved latanoprost group (p=0.028).
Improved Ocular Surface Health
A key advantage of the new formulation emerged in its effects on ocular surface disease (OSD), a common complication affecting 22-78% of glaucoma patients. The preservative-free emulsion demonstrated superior improvement in corneal fluorescein staining scores, decreasing from 1.4 to 0.8 compared to a reduction from 1.3 to 1.1 in the preserved latanoprost group (p=0.001).
Superior Patient Experience
Patient satisfaction metrics strongly favored the new formulation, with 98.4% of patients rating treatment as 'satisfactory' or 'very satisfactory' compared to 90.5% in the preserved latanoprost group. Notably, 52.4% of patients using the preservative-free formulation reported being 'very satisfied' versus 36.3% in the control group.
Safety Profile
The preservative-free formulation demonstrated an improved safety profile with fewer treatment-related adverse events (5.7%) compared to preserved latanoprost (10.9%). The most common side effects in both groups were ocular and conjunctival hyperemia, occurring at lower rates in the preservative-free group.
Clinical Implications
The study results suggest that the preservative-free latanoprost emulsion offers a compelling new treatment option that combines effective IOP control with better ocular surface protection. This dual benefit could potentially improve treatment adherence, a critical factor in managing glaucoma progression.
The cationic emulsion technology used in the formulation appears to provide additional benefits by stabilizing the tear film and improving ocular surface health, addressing an important aspect of long-term glaucoma management that has often been overlooked in traditional treatments.
