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.
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:
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, 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. Netarsudil works mainly by addressing the TM dysfunction, resulting in increased trabecular outflow of aqueous humour. Together with latanoprost, the complementary modes of action augment both aqueous outflow pathways.
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.
“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. An estimated 76 million people worldwide live with glaucoma. It is estimated that approximately 7.85 million people will suffer from glaucoma in Europe in 2040.