Glaucoma's Prospective First Line Agent: Rocklatan



Glaucoma is an eye disorder that has plagued the lives of over 3 million Americans (2019). The National Eye institute projects that this number will reach 4.2 million by the year 2030. The pathophysiology of glaucoma involves an increase in IOP due to an overproduction of aqueous humor, fluid that provides nutrients and maintains the IOP of the eye. Although increased IOP is not the sole diagnostic criteria for glaucoma, there is a positive correlation between the two as increased IOP is a risk factor. This increase in IOP can be observed in both open angle and closed angle glaucoma. However, open angle glaucoma is the most common form and accounts for over 90% of glaucoma cases in the US.

Currently, prostaglandin analogues are the first line agents for glaucoma and although there are four currently FDA approved for treatment of open angle glaucoma, Bimatoprost and Latanoprost are the most prescribed and thus are on the top 200 drug list. Prostaglandin analogues work by reducing intraocular pressure via increasing outflow of aqueous humor through the uveoscleral and to a lesser extent through the trabecular meshwork. However, in 2018 a novel agent by the name of Netarsudil (Rhopressa®) was FDA approved for treating OAG and functions as a rho kinase inhibitor. Rho associated kinase proteins are found within in the eyes and inhibiting them is thought to alter the distribution of actin stress fibers and modulate the cell matrix interactions of both the trabecular meshwork and Schlemm’s canal cells. Thereby, it mainly increases aqueous humor outflow through the trabecular meshwork.

Recently, on March 27 2019 a once daily ophthalmic combination drug containing Latanoprost and Netarsudil (Rocklatan®) was FDA approved for OAG. A Phase 3 clinical trial comparing the efficacy of Rocklatan® to Latanoprost and Rhopressa® alone showed statistically significant reductions in that 3x as many Rocklatan® patients achieved a IOP reduction of 40% or more from baseline versus the Latanoprost and Rhopressa® patients. Also, nearly 60% of Rocklatan® patients achieved and sustained an IOP of 16 mmHg or less versus 37% of latanoprost patients. The primary endpoints were mean IOP at nine time points (8 am, 10 am, 4 pm at week 2, week 6, and month 3) and patients enrolled had to have an IOP > 20 mmHg but < 36 mmHg with the duration of the trial being 3 months. The main adverse effect reported was conjunctival hyperemia in approximately 50% of patients with approximately 80% of those cases being mild. Therefore, these results shows promise with regard to Rocklatan® becoming a possible future first line agent for open angle glaucoma as its shown to be superior at reducing IOP compared to current first line therapy agent latanoprost.


References:

https://www.glaucoma.org/news/glaucoma-awareness-month.php

https://rocklatan.com/hcp/

http://investors.aeriepharma.com/static-files/f4a8a03c-e34e-4017-93db-5b5d17e2bd50

https://www.aao.org/interview/rho-kinase-inhibitors-glaucoma

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5591981/













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