Glanatec (Ripasudil) 0.4% ophthalmic solution, 5 ml, 5 vials: profile, composition and research

Reference page for Glanatec (Ripasudil) 0.4% ophthalmic solution, 5 ml, 5 vials. Active substance: Рипасудила гидрохлорид гидрат / Ripasudil hydrochloride hydrate.

Key facts

What ripasudil is

Ripasudil belongs to the group of Rho-kinase inhibitors. It was developed for topical use in ophthalmology and is supplied as a clear eye solution. The active substance is ripasudil hydrochloride hydrate.

The solution has a concentration of 0.4%. Each vial holds 5 ml, and a pack contains five vials. This is a topical form: the drops act directly in the front part of the eye rather than through the general bloodstream.

Ripasudil represents a comparatively new class of pressure-lowering agents that works differently from familiar prostaglandins or beta-blockers. It is considered when standard treatment proves insufficient or does not suit the patient.

How ripasudil lowers intraocular pressure

Rho kinase and the cytoskeleton

Rho kinase is an enzyme that governs the contractile machinery of a cell and the remodelling of its skeleton. In the trabecular meshwork of the eye, through which aqueous humour drains, the activity of this enzyme keeps the tissue tense and hinders the flow of fluid.

Opening the outflow pathways

Ripasudil suppresses Rho kinase, so the contractile structures of the trabecular meshwork relax, the spaces between them widen and aqueous humour leaves more easily. Pressure falls through better outflow rather than through reduced production of fluid.

Further effects

Studies also note an influence on the blood supply to the optic nerve. The mechanism is regarded as multi-component, so the medicine is examined not only as a pressure-lowering agent but also as possible support for nerve fibres.

Approved areas of use

The product information names glaucoma and ocular hypertension, including cases where other medicines have proved insufficient or cannot be used. Ripasudil is often prescribed in addition to drops already in use.

The medicine is instilled into the conjunctival sac. The number of instillations, the schedule and the duration are set by an ophthalmologist; a reference page does not replace that. The drops are applied so that the tip of the bottle does not touch the eye.

If other eye drops are used at the same time, an interval is left between instillations. With soft contact lenses a separate consultation is needed, because the preservative can accumulate in the lens.

What the research shows

The evidence base for ripasudil is smaller than for first-line glaucoma medicines. A review in Expert Opinion on Pharmacotherapy (2017) describes the mechanism and clinical profile of the substance, drawing mainly on Japanese studies.

A randomised study in JAMA Ophthalmology (2015) found an additional fall in pressure when ripasudil was added to timolol or latanoprost. That concerned a combination, not a replacement for baseline therapy.

A systematic review in Graefe's Archive (2022) pooled randomised work on Rho-kinase inhibitors and confirmed the pressure reduction, but noted that the follow-up periods are often short and that direct comparison with other drug classes is limited.

Published research

Primary sources, verified against PubMed:

• Additive Intraocular Pressure-Lowering Effects of the Rho Kinase Inhibitor Ripasudil (K-115) Combined With Timolol or Latanoprost: A Report of 2 Randomized Clinical Trials., PubMed 25880207 (JAMA Ophthalmol, 2015).
• Ripasudil hydrochloride hydrate: targeting Rho kinase in the treatment of glaucoma., PubMed 28893104 (Expert Opin Pharmacother, 2017).
• Intraocular pressure-lowering efficacy and ocular safety of Rho-kinase inhibitor in glaucoma: a meta-analysis and systematic review of prospective randomized trials., PubMed 34491427 (Graefes Arch Clin Exp Ophthalmol, 2022).
• Additive intraocular pressure-lowering effects of the Rho kinase inhibitor ripasudil in Japanese patients with various subtypes of glaucoma., PubMed 30368633 (Jpn J Ophthalmol, 2019).

Listed for reference. Publication of a study is not a claim about this particular product.

Precautions

• This is a prescription medicine. An ophthalmologist decides on treatment, sets the schedule and monitors progress.
• Common unwanted effects are conjunctival redness, conjunctival inflammation, blepharitis and eye irritation. Persistent symptoms should be reported to a doctor.
• The tip of the bottle must not touch the eye or the eyelid: this keeps the solution from being contaminated.
• With soft contact lenses the medicine is not advised without a specialist's opinion.
• Do not stop using the medicine unless a doctor tells you to, even if the condition seems stable.
• Tell your doctor about past allergic reactions, about pregnancy and breastfeeding, and about other medicines you take.

Frequently asked