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Crossover Randomized Study of Pharmacologic Effects of Ripasudil-Brimonidine Fixed-Dose Combination Versus Ripasudil
Hidenobu Tanihara1, Tetsuya Yamamoto2, Makoto Aihara3
1Department of Ophthalmology, Biei Municipal Hospital, 3-8-35 Naka-machi, Biei Town, Kamikawa-gun, Hokkaido, 071-0207, Japan. tanihara@pearl.ocn.ne.jp.
Advances in Therapy
|June 18, 2023
Summary
The fixed-dose combination of ripasudil-brimonidine (RBFC) effectively lowers intraocular pressure (IOP) compared to individual components. This combination drug offers a promising option for glaucoma management, potentially improving adherence.
Area of Science:
- Ophthalmology
- Pharmacology
Background:
- Glaucoma treatment adherence is often poor with multidrug regimens.
- Fixed-dose combination (FDC) drugs may improve adherence and simplify treatment.
- The ripasudil-brimonidine fixed-dose combination (RBFC) is a novel ophthalmic solution combining a Rho kinase inhibitor and an α2-adrenoceptor agonist.
Purpose of the Study:
- To evaluate the pharmacologic effects of RBFC compared to its individual components, ripasudil and brimonidine.
- To assess the efficacy of RBFC in reducing intraocular pressure (IOP).
- To investigate the safety and tolerability of RBFC, including effects on conjunctival hyperemia and corneal endothelium.
Main Methods:
- A single-center, prospective, randomized, open-label, blinded endpoint study with a 3x3 crossover design was conducted.
- Healthy adult men were assigned to three groups, receiving consecutive 8-day administrations of RBFC, ripasudil, and brimonidine with washout periods.
- Endpoints included changes in IOP, conjunctival hyperemia, corneal endothelial cell morphology, pupil diameter, and pharmacokinetics.
Main Results:
- RBFC significantly reduced IOP from baseline at 1-hour post-instillation on days 1 and 8.
- RBFC demonstrated significantly greater IOP reductions than ripasudil or brimonidine at multiple time points.
- The most common adverse event was mild conjunctival hyperemia; transient corneal endothelial cell changes occurred with RBFC and ripasudil, but not brimonidine.
Conclusions:
- RBFC significantly reduced IOP compared to monotherapy with ripasudil or brimonidine.
- RBFC exhibited a combined pharmacologic profile of its individual components.
- RBFC represents a potentially effective and well-tolerated treatment option for glaucoma management.
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