Ophthalmology Innovation Showcase 1 - Aerie Pharmaceuticals
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This document provides an overview of a company called Aerie Pharmaceuticals and their glaucoma products. It summarizes results from clinical trials of their two leading investigational drug candidates, Rhopressa and Roclatan. Rhopressa achieved non-inferiority compared to timolol in lowering eye pressure over 6 months in phase 3 trials. A pilot study also found Rhopressa to be effective at lowering pressure during nighttime hours. Roclatan was found to be statistically superior to its individual components, latanoprost and Rhopressa, in lowering pressure at all timepoints in a phase 3 trial. Both drugs demonstrated favorable safety profiles in clinical testing.
Ophthalmology Innovation Showcase 1 - Aerie Pharmaceuticals
- 1. Company Overview OIS @ ASCRS May 4, 2017 MLR-0035 New Investigational Drug OIS @ ASCRS 2017
- 2. Important Information Any discussion of the potential use or expected success of our product candidates is subject to our product candidates being approved by regulatory authorities. The information in this presentation is current only as of its date and may have changed or may change in the future. We undertake no obligation to update this information in light of new information, future events or otherwise. We are not making any representation or warranty that the information in this presentation is accurate or complete. Certain statements in this presentation are “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “will,” “should,” “would,” “could,” “believe,” “expects,” “anticipates,” “plans,” “intends,” “estimates,” “targets,” “projects,” “potential” or similar expressions are intended to identify these forward-looking statements. These statements are based on the Company’s current plans and expectations. Known and unknown risks, uncertainties and other factors could cause actual results to differ materially from those contemplated by the statements. In evaluating these statements, you should specifically consider various factors that may cause our actual results to differ materially from any forward-looking statements. These risks and uncertainties are described more fully in the quarterly and annual reports that we file with the SEC, particularly in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” In particular, the topline Rocket 4 data presented herein is preliminary and based solely on information available to us as of the date of this press release and additional information about the results may be disclosed at any time. Such forward-looking statements only speak as of the date they are made. We undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events or otherwise, except as otherwise required by law. 2
- 3. 3 Aerie Current Glaucoma Products – Patented thru 2030 Pre-Clinical Research • Rhopressa ™ • Improved aqueous outflow via the trabecular meshwork • Anti-fibrotic activity in cultured human trabecular meshwork cells • AR-13154 • Significant lesion size reduction in wet AMD model • Rhopressa ™ (netarsudil ophthalmic solution) 0.02% • Inhibits ROCK, NET, lowers EVP, targets diseased tissue • NDA resubmitted in February 2017; entering launch mode • Roclatan ™ (netarsudil / latanoprost ophthalmic solution) 0.02% / 0.005% • Fixed combination of Rhopressa ™ and latanoprost • Two Phase 3’s in process; first P3 achieved primary efficacy endpoint Aerie – Building a Major Ophthalmic Pharmaceutical Company Data on file OIS @ ASCRS 2017
- 4. 44 RhopressaTM Once-Daily Efficacy Performance: Summary To Date Well researched by 200+ eye doctors in over 2,000 clinical patients Once-daily efficacy demonstrated in 4 Phase 3 trials achieving non-inferiority vs B.I.D. timolol (Rocket 1, 2, 4) and latanoprost (Mercury 1) in subjects with baseline IOP < 25 mmHg Stable IOP lowering through 12 months, no evidence of “IOP drift” Initial evidence of 24-hour IOP control Additional differentiating attributes e.g., trabecular meshwork outflow and anti-fibrotic effects OIS @ ASCRS 2017
- 5. Rocket 4: RhopressaTM Achieved Non-Inferiority in the Primary Efficacy Analysis (Baseline IOP < 25 mmHg) Mean IOP at Each Time Point (PP) – Topline 6-Month 5 • Rhopressa ™ performance remained within the non-inferiority range through 6 months ++Data on File Based on Rocket 4 Topline 6-month safety
- 6. Rocket 4: RhopressaTM Efficacy Stable through 6 Months (8 AM IOP) Baseline < 27 mmHg Rhopressa™ (n=xx) BL W2 W6 M3 M4 M5 M6 ++Data on File Based on Rocket 4 Topline 6-month 8am IOP 6 BL W2 W6 M3 M4 M5 M6 Baseline < 25 mmHg Rhopressa™ (n=186) Rhopressa™ (n=240)
- 7. 7 Rhopressa™ 24-hour IOP Pilot Study Demonstrates Effective Nocturnal Efficacy Rhopressa™ (n=8) Baseline (n=8) ** ** ** *** ** ** *** *** ** p<0.01 *** p<0.001 • Rhopressa™ equally effective during nocturnal and diurnal periods • Current glaucoma medications either have no efficacy at night (beta blockers, alpha agonists) or reduced efficacy at night (PGAs, CAIs) 1 - 6 Data on File: AR-13324-CS204 1. Liu JH, et al. Am J Ophthalmol. 2004; 138:389-395. 2. Gulati V, et al. Arch Ophthalmol. 2012; 130:677-684. 3. Liu JH, et al. Ophthalmology. 2009; 116:449-454. 4. Liu JH, et al. Ophthalmology. 2010; 117:2075-9. 5. Fan S et al. J Glaucoma. 2014; 23:276-81. 6. Liu JH, et al. Am J Ophthalmol. 2016;169:249-257. Pre-dose Post-dose (Day 8/9)
- 8. 88 RhopressaTM Once-Daily Safety Performance: Summary To Date Well tolerated with no evidence of treatment-related serious or systemic AEs Most common AE: conjunctival hyperemia, ~48% incidence - mild for ~75% of patients and sporadic; only 10% of subjects had hyperemia at each study visit. - 4% discontinued due to hyperemia. 20% of subjects had hyperemia at post-washout baseline prior to initiating treatment AEs occurring in ~5-25% of subjects included: cornea verticillata, conjunctival hemorrhage (petechiae), lacrimation increased, erythema of eyelid and vision blurred
- 9. 9 RoclatanTM Achieved Statistical Superiority Over Individual Components At All 9 Time Points Mean IOP at Each Time Point (ITT) ***p<0.0001 vs Latanoprost and RhopressaTM Data on File In Mercury 1, Roclatan™ IOP lowering was 1-3 mmHg greater than monotherapy with latanoprost or Rhopressa™ Mean IOP at Each Time Point (ITT)
- 10. 10 Mercury 1: RoclatanTM Phase 3 Responder Analysis Day 90: % of Patients with IOP Reduced to 18 mmHg or Lower *** *** *** 14% 23% 32% 42% 54% 15% 25% 39% 54% 69% 33% 44% 61% 71% 82% 0% 20% 40% 60% 80% 100% ≤ 14 mmHg ≤ 15 mmHg ≤ 16 mmHg ≤ 17 mmHg ≤ 18 mmHg %ofPatients IOP on Treatment Rhopressa™ (n=198) Latanoprost (n=223) Roclatan™ (n=200) ### ### ***p<0.0001 vs Latanoprost and RhopressaTM ###p<0.0001 vs RhopressaTM, p<0.05 vs Latanoprost Data on file and PG324 - CS301
- 11. 11 Mercury 1: Safety/Tolerability Overview of RoclatanTM • There were no drug-related serious or systemic adverse events • The most common adverse event was conjunctival hyperemia with ~50% incidence*, ~80% mild on biomicroscopy • Other ocular AEs – AEs occurring in ~5-11% of subjects receiving RoclatanTM included: conjunctival hemorrhage, eye pruritus, lacrimation increased and cornea verticillata. * Incidence of conjunctival hyperemia ~50% including baseline at ~20% Data on file and PG324 - CS301