Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings.

Abstract

PURPOSE:

To compare the diurnal intraocular pressure (IOP)-lowering effect of latanoprostene bunod (LBN) 0.024% with timolol maleate 0.5% in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).

PATIENTS AND METHODS:

Pooled analysis of two phase 3, randomized, multicenter, double-masked, parallel-group, noninferiority trials (APOLLO and LUNAR), each with open-label safety extension phases. Adults with OAG or OHT were randomized 2:1 to double-masked treatment with LBN once daily (qd) or timolol twice daily (bid) for 3 months followed by open-label LBN treatment for 3 (LUNAR) or 9 (APOLLO) months. IOP was measured at 8 AM, 12 PM, and 4 PM at week 2, week 6, and months 3, 6, 9, and 12.

RESULTS:

Of the 840 subjects randomized, 774 (LBN, n=523; timolol crossover to LBN, n=251) completed the efficacy phase, and 738 completed the safety extension phase. Mean IOP was significantly lower with LBN versus timolol at all 9 evaluation timepoints during the efficacy phase (P<0.001). A significantly greater proportion of LBN-treated subjects attained a mean IOP ≤18 mm Hg and IOP reduction ≥25% from baseline versus timolol-treated subjects (P<0.001). The IOP reduction with LBN was sustained through the safety phase; subjects crossed over from timolol to LBN experienced additional significant IOP lowering (P≤0.009). Both treatments were well tolerated, and there were no safety concerns with long-term LBN treatment.

CONCLUSIONS:

In this pooled analysis of subjects with OAG and OHT, LBN 0.024% qd provided greater IOP-lowering compared with timolol 0.5% bid and maintained lowered IOP through 12 months. LBN demonstrated a safety profile comparable to that of prostaglandin analogs.

• Authors: Robert N Weinreb, Jeffrey M Liebmann, Keith R Martin, Paul L Kaufman, Jason L Vittitow
• Journal: Journal of glaucoma (J Glaucoma) Vol. 27 Issue 1 Pg. 7-15 (01 2018) ISSN: 1536-481X [Electronic] United States
• PMID: 29194198 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antihypertensive Agents
• BOL 303259-X
• Ophthalmic Solutions
• Prostaglandins F, Synthetic
• Timolol

Topics

• Adult
• Aged
• Aged, 80 and over
• Antihypertensive Agents (therapeutic use)
• Cross-Over Studies
• Double-Blind Method
• Female
• Glaucoma, Open-Angle (drug therapy, physiopathology)
• Humans
• Intraocular Pressure (drug effects)
• Male
• Middle Aged
• Ocular Hypertension (drug therapy, physiopathology)
• Ophthalmic Solutions
• Prostaglandins F, Synthetic (therapeutic use)
• Timolol (therapeutic use)
• Tonometry, Ocular
• Visual Acuity (physiology)
• Young Adult