• The first new mechanisms of action (MOA) in a generation to treat patients with glaucoma1 2
  • Designed to reduce elevated intraocular pressure (IOP), the cause of vision loss in open-angle glaucoma
  • Two late development-stage products – Rhopressa™ (netarsudil ophthalmic solution) 0.02% and Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
  • Both products are eye drops taken once a day in the evening
  • Each product has multiple mechanisms of action, including the novel targeting of the diseased tissue, or main drain in the eye – the source of elevated IOP; potential for disease modification
  • Blockbuster revenue potential in an approximately $5 billion market in the U.S., Europe and Japan, which is expected to grow to more than $8 billion by 2023
  • All products fully owned by Aerie with patents through at least 2030

Rhopressa:

  • Resubmitted NDA on February 28, 2017
  • Mechanisms of action –
    • Increases fluid outflow through the eye’s main drain, the diseased tissue in glaucoma1
    • Reduces pressure in the episcleral veins, where eye fluid is ultimately absorbed2
    • May reduce production of eye fluid1

Roclatan:

  • A fixed-dose combination product currently in Phase 3 registration trials
  • A combination of Rhopressa™ ophthalmic solution with latanoprost, the most prescribed medication currently approved to treat glaucoma.
  • All of the mechanisms of action of Rhopressa™ ophthalmic solution while also adding the targeting of the eye’s secondary drain. 3
  • Based on the Mercury 1 Phase 3 registration trial top line data – lowering IOP by 1.3 to 2.5 mmHg greater than market leading latanoprost and generating IOP reductions of over 35% in nearly half of the patients in the study – over twice that of latanoprost in the same study.4

Research Initiatives:

  • The active ingredient of Rhopressa™ ophthalmic solution, AR-13324, has preclinically demonstrated the potential to have disease-modifying activity in glaucoma patients by stopping and reversing fibrosis in the trabecular meshwork, and also increasing perfusion in the trabecular outflow pathway thus increasing both drainage and the delivery of nutrients to the diseased tissue.
  • Our research has also shown the potential of Rhopressa™ ophthalmic solution to promote retinal ganglion cell survival and axon regeneration thus showing the potential for neuroprotection.
  • Our owned molecule AR-13154 has preclinically demonstrated the potential for the treatment of wet AMD (age-related macular degeneration), with significant lesion size reduction.

Business Development:

  • Evaluating technology for sustained delivery of Rhopressa™ ophthalmic solution to the front of the eye for the treatment of glaucoma or ocular hypertension, and technology for sustained delivery of AR-13154 to the back of the eye for wet AMD.
References
  1. Wang RF, Williamson JE, Kopczynski C, Serle JB. Effect of 0.04% AR-13324, a ROCK, and norepinephrine transporter inhibitor, on aqueous humor dynamics in normotensive monkey eyes. J Glaucoma 2015. 24(1):51-4.
  2. Kiel JW, Kopczynski C. Effect of AR-13324 on Episcleral Venous Pressure (EVP) in Dutch Belted Rabbits. J Ocul Pharmacol Ther 2015; 31(3):146-151.
  3. Xalatan® Package Insert Revised November 2014.
  4. Data on File.