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17-Jul-2023

Santen launches Roclanda®, with the ROCK inhibitor netarsudil, in the UK – representing the first new class of medication for the medical management of glaucoma in Europe in 25 years

Today, Santen, a global specialist in ophthalmology, announces the launch of Roclanda® in the UK. Roclanda® is a fixed-dose combination (FDC) of latanoprost and netarsudil, a novel Rho-kinase (ROCK) inhibitor, that effectively lowers intraocular pressure (IOP) while targeting trabecular meshwork (TM) dysfunction.2,3


Roclanda is indicated for the reduction of elevated IOP in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil insufficient IOP reduction.2
As the only modifiable risk factor for the development and progression of the disease, controlling IOP remains the cornerstone of glaucoma management.4,5,6,7 However, despite the proven efficacy of currently available topical therapies, some patients still progress to vision loss.8
As the main pathway responsible for aqueous humour (AH) drainage out of the eye, the TM plays a critical role in maintaining IOP within a normal range.4,9 Dysfunction of the TM is recognised as a primary cause of increased outflow resistance and subsequent elevation of IOP, making it one of the most significant factors underlying primary open-angle glaucoma (POAG).10,11,12,13,14,15


Until now, no currently available medical therapies have directly targeted this underlying cause;5 they solely act to lower IOP by primarily targeting uveoscleral outflow and/or AH production.5,16*
“The launch of Roclanda® is a significant moment in the management of glaucoma. Evidence shows there is a clear benefit to addressing both aqueous humour outflow mechanisms to effectively control intraocular pressure. The introduction of Roclanda® in the UK represents a paradigm shift in the medical management of glaucoma, bringing therapy closer to a source of the disease†”, says Dr Nishani Amerasinghe, ophthalmology surgeon consultant University Hospital Southampton.

The introduction of Roclanda®, with the ROCK inhibitor netarsudil, represents the first new class of medication for medical management of glaucoma in Europe in 25 years,1 and signifies a new direction for the management of glaucoma for UK patients. POAG affects about 2% of people in the UK older than 40 years.17 The prevalence increases with increasing age.

About Roclanda®
Netarsudil and latanoprost act in a complementary manner to target both outflow pathways implicated in elevated IOP; increasing outflow through both the trabecular (‘conventional’) and uveoscleral (‘unconventional’) pathways.2 A FDC of netarsudil 0.02% and latanoprost 0.005% received FDA approval in March 2019 (Rocklatan®), and EMA approval in January 2021 (Roclanda®), for the reduction of elevated IOP in adult patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.2,18 Netarsudil/latanoprost FDC (NET/LAT) has demonstrated statistically superior (p<0.0001) reduction in IOP compared with netarsudil and latanoprost individually at all timepoints from Week 2 through to the primary efficacy endpoint at 3 months in the MERCURY-1 and -2 studies, within the individual trials and as a pooled analysis.18,19,20 In clinical trials, NET/LAT FDC is generally well tolerated and the majority of reported adverse events are mild.2,15

About Santen
As a specialised company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and devices. Santen has long been the market leader in Japan for prescription ophthalmic pharmaceuticals and is now a leader in this sector in the EMEA (Europe, Middle East and Africa) region. With scientific knowledge and organisational capabilities nurtured over 130 years, Santen provides products and services to contribute to the well-being of patients, their loved ones, and consequently to society, in more than 60 countries. For more information, please visit Santen’s websites www.santen.com (Japan headquarters) and www.santen.eu (EMEA).

Isabelle Scali, MHP group, +44 (0)7824 142725
*Cholinergic medications (e.g. pilocarpine) facilitate AH outflow indirectly by contraction of the ciliary muscle, tension of the scleral spur and traction on the TM.10
†POAG.

1 Schehlein EM, Robin AL. Rho-associated kinase inhibitors: Evolving strategies in glaucoma treatment. Drugs 2019;79:1031–6.
2 Roclanda® (latanoprost 0.005%/netarsudil 0.02% eye drops, solution). Summary of Product Characteristics. Last updated December 2022.
3 Buffault J, et al. The dual effect of Rho-kinase inhibition on trabecular meshwork cells cytoskeleton and extracellular matrix in an in vitro model of glaucoma. J Clin Med 2022;11:1001.
4 Machiele R, et al. Intraocular pressure. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022. Available at: https://www.ncbi.nlm.nih.gov/books/NBK532237.
5 European Glaucoma Society (EGS)., 5th edition. Br J Ophthalmol 2021;105(Suppl 1):1–169.
6 Storgaard L, et al. Glaucoma clinical research: Trends in treatment strategies and drug development. Front Med (Lausanne) 2021;8:733080

 

 

 

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Last Updated: 17-Jul-2023