- The first new chemical entity 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
- One approved product – Rhopressa® (netarsudil ophthalmic solution) 0.02% and one late development-stage product – Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%
- Both products are eye drops taken once a day in the evening
- Significant 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
- FDA U.S. approval obtained December 18, 2017. Phase 1 and Phase 2 clinical trials in process for potential approval in Japan.
- Mechanism of action –
- Increases fluid outflow through the eye’s main drain, the diseased tissue in glaucoma1
- A fixed-dose combination product that completed two successful Phase 3 registration trials in the United States. NDA filing expected in 2Q 2018. Ongoing Phase 3 clinical trial in Europe for the European market.
- A combination of Rhopressa® ophthalmic solution with latanoprost, the most prescribed medication currently approved to treat glaucoma.
- The mechanism of Rhopressa® ophthalmic solution while also adding the targeting of the eye’s secondary drain. 3
- Based on Mercury 1 Phase 3 registration trial topline date — Roclatan™ reduced mean diurnal IOPs to 16 mmHg or lower in 61% of patients, compared to 39% of patients for latanoprost.
- Based on Mercury 2 Phase 3 registration trial topline date — Roclatan™ reduced mean diurnal IOPs to 16 mmHg or lower in 56% of patients, compared to 36% of patients for latanoprost.
Research and Business Development Initiatives and Expansion Opportunities:
- 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.
- Rhopressa® has demonstrated effective nocturnal efficacy in a 24-hour IOP pilot study. Current glaucoma medications either have no efficacy at night or reduced efficacy at night.
- Our owned molecule AR-13503 has preclinically demonstrated the potential for the treatment of wet AMD (age-related macular degeneration) and DME (diabetic macular edema), with significant lesion size reduction comparable to a current market leading product, and has also shown preclinically that it meaningfully enhances the efficacy of the market leading product when taken in combination.
- AR-1105 dexamethasone steroid preclinical candidate for the treatment of DME.
- DSM collaboration focused on development of sustained-release, bio-erodible implant technology for evaluation in use with Aerie’s retinal disease product candidates.
- Ophthalmic rights to PRINT® manufacturing technology capable of creating precisely engineered sustained-release products using fully scalable manufacturing processes. Expected to accelerate Aerie’s retinal disease program.
- Evaluating Aerie’s 3,000+ owned Rock inhibitor molecules for additional indications beyond ophthalmology.
- Expanding to Europe and Japan. Executing clinical trial programs and developing commercialization strategies.
- Construction of manufacturing facility in Ireland underway.
- 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.
- 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.
- Xalatan® Package Insert Revised November 2014.