Study: MERCURY-3 trial results support efficacy of Roclanda

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A study, citing results from the MERCURY-3 trial of latanoprost/netarsudil fixed-dose combination (Roclanda, Santen), back it up as an alternative fixed-dose combination (FDC) treatment option for patients with primary open-angle glaucoma (POAG) or ocular hypertension.¹

According to a news release from Santen, the study was published recently in the peer-review journal, Graefe’s Archive for Clinical and Experimental Ophthalmology.

According to the news release, the MERCURY-3 trial was a 6-month prospective, double-masked, randomized, multicenter, 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

The news release noted 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

According to Santen, 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,” Professor Ingeborg Stalmans of University Hospitals UZ Leuven, Belgium, said in the news release.

Ioana Grobeiu, vice-president, Medical Affairs Santen EMEA, pointed out in the news release the therapeutic could fill a void.

“There is still a considerable unmet need in glaucoma – people continue to suffer from glaucoma-related vision loss despite the many options already available,” Grobeiu said in the news release. “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

According to the news release, In October 2020 Santen and Aerie entered into an exclusive development and commercialization 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.

In December 2021, Santen announced the global expansion of its exclusive development and commercialization 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.

According to the news release, Roclanda is approved and sold in the United States by Aerie Pharmaceuticals under the name Rocklatan.

References:

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. Rho-Associated Kinase Inhibitors: Evolving Strategies in Glaucoma Treatment. Drugs. 2019 Jul;79(10):1031-1036. doi: 10.1007/s40265-019-01130-z. PMID: 31134520.

3. Ren R, Li G, Le TD, Kopczynski C, Stamer WD, Gong H. Netarsudil Increases Outflow Facility in Human Eyes Through Multiple Mechanisms. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6197-6209. doi: 10.1167/iovs.16-20189. PMID: 27842161; PMCID: PMC5114035.

4. Asrani S, Bacharach J, Holland E, McKee H, Sheng H, Lewis RA, Kopczynski CC, Heah T. Fixed-Dose Combination of Netarsudil and Latanoprost in Ocular Hypertension and Open-Angle Glaucoma: Pooled Efficacy/Safety Analysis of Phase 3 MERCURY-1 and -2. Adv Ther. 2020 Apr;37(4):1620-1631. doi: 10.1007/s12325-020-01277-2. Epub 2020 Mar 12. PMID: 32166538; PMCID: PMC7140751.

5. European Medicines Agency (EMA). Roclanda summary of product characteristics. https://www.ema.europa.eu/en/medicines/human/EPAR/roclanda

6. Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012 May;96(5):614-8. doi: 10.1136/bjophthalmol-2011-300539. Epub 2011 Dec 1. PMID: 22133988.

7. Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224. PMID: 16488940; PMCID: PMC1856963.

8. Allison K, Patel D, Alabi O. Epidemiology of Glaucoma: The Past, Present, and Predictions for the Future. Cureus. 2020 Nov 24;12(11):e11686. doi: 10.7759/cureus.11686. PMID: 33391921; PMCID: PMC7769798.

9. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26. PMID: 24974815.