Mercury-3 trial data published in Graefe’s Archive for Clinical and Experimental Ophthalmology
MERCURY-3 trial data show Roclanda® – latanoprost/netarsudil fixed dose combination – demonstrated comparable IOP lowering efficacy to bimatoprost/timolol combination, in patients with primary open-angle glaucoma or ocular hypertension
Results newly published in the peer-review journal, Graefe’s Archive for Clinical and Experimental Ophthalmology, from the MERCURY-3 trial support the addition of Roclanda® as an alternative fixed-dose combination (FDC) treatment option for patients with primary open-angle glaucoma (POAG) or ocular hypertension.1
MERCURY-3 was a 6-month prospective, double-masked, randomised, multicentre, active-controlled, parallel-group non-inferiority study comparing Roclanda® – FDC of latanoprost 50 micrograms/ml and netarsudil 200 micrograms/ml ophthalmic solution – with FDC of bimatoprost 300 micrograms and timolol maleate 500 micrograms/ml. The primary efficacy endpoint of non-inferiority at month 3 was assessed and met.
Key findings from the MERCURY-3 trial for latanoprost/netarsudil FDC include:1
- Comparable IOP lowering versus bimatoprost/timolol at all time points
- Sustained IOP reduction through 6 months
- No serious treatment-related adverse events (AEs) and minimal systemic AEs.
The rho kinase inhibitor netarsudil is the first new therapeutic class in the medical management of glaucoma during the last 25 years in Europe,2 which brings a novel mode of action by primarily targeting trabecular meshwork (TM) dysfunction. In open-angle glaucoma, cellular dysfunction of the TM can lead to contraction and stiffness resulting in increased outflow resistance causing an elevation of IOP.3 Netarsudil works mainly by addressing the TM dysfunction, resulting in increased trabecular outflow of aqueous humour.3 Together with latanoprost, the complementary modes of action augment both aqueous outflow pathways.4
Roclanda® is indicated for the reduction of elevated IOP in adult patients with POAG or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.5
“These data underline the role for Roclanda® with its complementary modes of action for those with POAG or ocular hypertension for whom monotherapy has provided insufficient IOP reduction. It is refreshing to have a new option after a long period without innovation in medical therapy for glaucoma,” said Professor Ingeborg Stalmans of University Hospitals UZ Leuven, Belgium.
Ioana Grobeiu, Vice-President, Medical Affairs Santen EMEA added, “There is still a considerable unmet need in glaucoma – people continue to suffer from glaucoma-related vision loss despite the many options already available. Therapeutic progress is still very much in demand, so Santen is incredibly proud to bring this innovation to the ophthalmology community across the region.”
Glaucoma affects the optic nerve connecting the eye to the brain and it is the second most common cause of blindness worldwide.6,7,8 An estimated 76 million people worldwide live with glaucoma.8,9 It is estimated that approximately 7.85 million people will suffer from glaucoma in Europe in 2040.9
As a specialised company dedicated to ophthalmology with a global footprint in over 60 countries, Santen is committed to reducing the loss of social and economic opportunities due to eye conditions, aspiring to bring “Happiness with Vision” around the world.
1. Stalmans I, et al. Graefes Arch Clin Exp Ophthalmol 2023 https://doi.org/10.1007/s00417-023-06192-0
2. Schehlein EM, Robin AL. Drugs 2019;79:1031–6
3. Ren R, Li G et al. Invest Ophthalmol Vis Sci. 2016;1;57(14):6197-6209
4. Asrani S, Bacharach J et al. Adv Ther. 2020;37:1620-1631
5. European Medicines Agency (EMA). Roclanda summary of product characteristics
6. Pascolini D et al. Br J Ophthalmol. 2012;96:614-618
7. Quigley HA et al. Br J Ophthalmol. 2006;90:262-267
8. Allison, K., Patel, D. and Alabi, O., 2020. Cureus, 12(11)
9. Tham Y-C et al. Ophthalmology. 2014;121(11):2081-2090
Notes to editors
In October 2020 Santen and Aerie entered into an exclusive development and commercialisation agreement for Rhopressa® (netarsudil 0.02%) and Rocklatan® (netarsudil 0.02% and latanoprost 0.005%) in Japan, along with rights for several other Asian countries. On 7 December 2021, Santen announced the global expansion of its exclusive development and commercialisation agreement with Aerie to target additional territories including Europe, China and several other regions. Roclanda® was approved by the European Medicines Agency (EMA) in January 2021. Roclanda® is approved and sold in the United States by Aerie Pharmaceuticals (“Aerie”) under the name Rocklatan®.
About Santen As a global specialised company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices that benefit patients in over 60 countries. Santen’s long-term vision is to become a social innovator in ophthalmology and address social and economic issues related to eye health by strategically exploring advancing technologies and collaborating with key leaders around the world. Underpinned by its people-centric values, Santen aims to ultimately deliver happiness with vision – a life with the best vision experience for every individual around the world. 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. For more information, please visit Santen’s websites www.santen.eu (Europe, Middle East and Africa, EMEA) and www.santen.com (Japan headquarters).
Document number: NP-ROC-EMEA-0076
Date of preparation: August 2023