Roclatan TM Mercury 1 Phase 3 Topline Results 1 Exhibit 99.2 |
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 Mercury 1 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, including at our Investor Day on October 5, 2016. 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 |
• Roclatan™ met the criteria for demonstrating superiority over both latanoprost and Rhopressa™ for the primary efficacy analysis – statistical superiority of Roclatan™ was demonstrated at all 9 time points versus latanoprost and versus Rhopressa™ (p<0.0001) • IOP-lowering effect of Roclatan™ was greater (1-3 mmHg) than monotherapy with either latanoprost or Rhopressa™ throughout the duration of the study (i.e., Week 2, Week 6, Month 3) • Roclatan™ reduced mean diurnal IOPs to 16 mmHg or lower in 61 percent of patients, a significantly higher percentage than observed in the comparator arms • The main adverse event for Roclatan™ was conjunctival hyperemia, which was reported in ~50% of patients and was scored as mild for ~80% of these patients • There were no drug-related serious adverse events and no evidence of treatment-related systemic effects Roclatan TM Achieves Primary Clinical Endpoint 3 |
Mercury 1 Trial Design Patients randomized 1:1:1 Primary endpoints: • Efficacy: Mean IOP at nine time points (08:00, 10:00, and 16:00 at Week 2, Week 6, and Month 3) • Safety: Ocular and systemic safety during a 12-month treatment period ClinicalTrials.gov Identifier: NCT02558400 Patients with open angle glaucoma (OAG) or ocular hypertension (OHT) with IOP >20 mmHg and < 36 mmHg N=718 subjects randomized at 58 US sites Roclatan TM PG324 (netarsudil/latanoprost) QD (PM) Rhopressa Netarsudil (AR-13324) 0.02% QD (PM) Latanoprost 0.005% QD (PM) 4 TM |
Disposition Completed Month 3 201 (84.5%) 201 (82.4%) 223 (94.5%) Discontinued Prior to Month 3 37 (15.5%) 43 (17.6%) 13 (5.5%) Reasons for Discontinuation Adverse Event Withdrawal of Consent Non-Compliant Lost to Follow-up Lack of Efficacy Disallowed Concurrent Medication Investigator Decision Protocol Violation Other 25 (10.5%) 4 (1.7%) 0 1 (0.4%) 0 1 (0.4%) 2 (0.8%) 4 (1.7%) 0 23 (9.4%) 4 (1.6%) 1 (0.4%) 3 (1.2%) 5 (2.0%) 4 (1.6%) 0 1 (0.4%) 2 (0.8%) 0 4 (1.7%) 1 (0.4%) 1 (0.4%) 1 (0.4%) 1 (0.4%) 0 5 (2.1%) 0 5 Roclatan TM N = 238 Rhopressa TM N = 244 Latanoprost N = 236 |
Study Design And Analysis • Trial design follows FDA requirement for fixed dose combination – Superiority of combination over each individual component – Statistically significant difference at each measured time point – Higher combo efficacy vs. components at ~1-3 mmHg, as previously accepted by FDA for product approval (i.e., Simbrinza ® ) • The primary statistical modeling of the primary efficacy analysis was agreed with the FDA using the intent to treat (ITT) population with imputation for any missing data* *FDA End of Phase 2 meeting minutes 6 |
Roclatan TM Achieved Statistical Superiority Over Individual Components at All Time Points Mean IOP at Each Time Point (ITT) ***p<0.0001 vs Latanoprost and Rhopressa TM 7 |
Roclatan TM Phase 3, ITT Roclatan TM superior to latanoprost by 1.3 - 2.5 mmHg (p<0.0001) Roclatan TM superior to Rhopressa TM by 1.8 - 3.0 mmHg (p<0.0001) 8 8:00 AM 24.8 24.8 24.6 10:00 AM 23.7 23.5 23.4 4:00 PM 22.6 22.6 22.4 Mean Diurnal 23.7 23.6 23.5 8:00 AM 15.6 18.6 17.8 -3.0 (-3.6, -2.5) -2.2 (-2.8, -1.7) 10:00 AM 14.9 17.8 17.4 -2.9 (-3.5, -2.3) -2.5 (-3.1, -1.9) 4:00 PM 14.8 17.2 17.2 -2.4 (-2.9, -1.9) -2.3 (-2.9, -1.8) Mean Diurnal 15.1 17.9 17.5 -2.8 (-3.3, -2.3) -2.4 (-2.9, -1.9) 8:00 AM 16.0 19.0 17.7 -3.0 (-3.6, -2.4) -1.7 (-2.3, -1.1) 10:00 AM 15.3 18.0 17.1 -2.7 (-3.3, -2.2) -1.9 (-2.5, -1.3) 4:00 PM 15.3 17.5 17.0 -2.2 (-2.7, -1.6) -1.7 (-2.2, -1.1) Mean Diurnal 15.5 18.2 17.3 -2.7 (-3.1, -2.2) -1.8 (-2.3, -1.3) 8:00 AM 16.2 18.9 17.6 -2.7 (-3.4, -2.1) -1.5 (-2.1, -0.9) 10:00 AM 15.3 18.2 16.9 -2.9 (-3.5, -2.3) -1.6 (-2.2, -1.0) 4:00 PM 15.4 17.2 16.7 -1.8 (-2.4, -1.2) -1.3 (-2.0, -0.7) Mean Diurnal 15.6 18.1 17.1 -2.5 (-3.0, -2.0) -1.5 (-2.0, -1.0) Day 90 Mean IOP mmHg Rhopressa™ Day 43 Day 15 Latanoprost Difference from Roclatan™ (95% CI) Roclatan™ N=238 Rhopressa™ N=244 Latanoprost N=236 Baseline |
Roclatan TM Phase 3 Responder Analysis Day 90: % of Patients with IOP Reductions of 20% ***p<0.0001 vs Latanoprost and Rhopressa TM ### p<0.0001 vs Rhopressa TM , p<0.05 vs Latanoprost *** *** *** ### 9 7% 18% 29% 43% 56% 9% 21% 37% 61% 78% 35% 46% 65% 77% 88% 0% 20% 40% 60% 80% 100% 40% 35% 30% 25% 20% ### Rhopressa™(n=198) Latanoprost (n=223) Roclatan™ (n=200) Reduction |
Roclatan TM Phase 3 Responder Analysis Day 90: % of Patients with IOP Reduced to 18 mmHg or Lower *** *** *** 10 14% 23% 32% 42% 54% 15% 25% 39% 54% 69% 33% 44% 61% 71% 82% 0% 20% 40% 60% 80% 100% IOP on Treatment Rhopressa™ (n=198) Latanoprost (n=223) Roclatan™ (n=200) ### ### ***p<0.0001 vs Latanoprost and Rhopressa TM ### p<0.0001 vs Rhopressa TM , p<0.05 vs Latanoprost 17 mmHg 18 mmHg 16 mmHg 15 mmHg 14 mmHg |
Safety/Tolerability Overview of Roclatan TM • There were no drug-related serious adverse events (SAEs) • There were no evidence of treatment-related systemic effects • 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 Roclatan TM included: conjunctival hemorrhage, eye pruritus, lacrimation increased and cornea verticillata. * Incidence of conjunctival hyperemia ~50% including baseline at ~20% 11 |
Roclatan TM Phase 3 Safety Profile Eye Disorders Conjunctival Hyperemia 126 (52.9%) 99 (40.6%) 33 (14.0%) Conjunctival Hemorrhage 25 (10.5%) 34 (13.9%) 1 ( 0.4%) Eye Pruritus 18 ( 7.6%) 17 ( 7.0%) 3 ( 1.3%) Lacrimation Increased 14 ( 5.9%) 15 ( 6.1%) 1 ( 0.4%) Cornea Verticillata 12 ( 5.0%) 9 ( 3.7%) 0 (0.0%) Administration Site Conditions Instillation site pain 45 (18.9%) 51 ( 20.9%) 15 ( 6.4%) Patients with known contraindications or hypersensitivity to latanoprost were excluded 12 n=238 Roclatan TM Rhopressa TM n=244 Latanoprost n=236 Adverse Events ( 5.0% in any group) |
Conjunctival Hyperemia Adverse Event rates: • Roclatan TM : ~50% • Rhopressa TM : ~40% • ~50% reported in Rocket 1 and Rocket 2 • Latanoprost: ~15 % Biomicroscopy: • ~80% hyperemia graded as mild (Roclatan TM and Rhopressa TM ) – Hyperemia severity did not increase with continued dosing – Majority of the hyperemia was sporadic Hyperemia severity 0 = none 1 = mild 2 = moderate 3 = severe 13 0.0 0.5 1.0 1.5 2.0 2.5 3.0 Baseline Week 2 Week 6 Month 3 Roclatan™ (N=238) Rhopressa™ (N=244) |
14 When Present, 80% of Roclatan TM QD Hyperemia Graded as Mild For illustrative purposes only Grade Image Description 0 None/Normal 1 Mild 2 Moderate 3 Severe |
Conjunctival Hemorrhage Subconjunctival petechiae coded as conjunctival hemorrhage: • Roclatan TM : ~10% • Rhopressa TM : ~14% • ~14% reported in Rocket 1 and Rocket 2 • Latanoprost: <1% 15 |
Cornea Verticillata Cornea verticillata (lipid micro-deposits in the corneal epithelial layer) • Roclatan TM : ~5% • Rhopressa TM : ~4% • ~5-9% reported in Rocket 1 and Rocket 2 • Asymptomatic • Only visible via biomicroscopy evaluation • Benign corneal deposits (phospholipidosis) are a familiar outcome with other drugs such as amiodarone 16 |
Rhopressa TM Performance Summary • Demonstrated non-inferiority to latanoprost in patients with baseline IOP < 25 mmHg • Efficacy relative to latanoprost improves as baseline IOP declines • Rhopressa TM maintained consistent IOP lowering across all baseline IOPs including > 25 mmHg • Stable efficacy from week 2 to month 3 • Adverse event profile consistent with previous studies 17 |
Roclatan™ Summary • Demonstrated superiority over both latanoprost and Rhopressa™ for the primary efficacy analysis at all 9 time points (p<0.0001) • IOP-lowering effect was greater (1-3 mmHg) than monotherapy with either latanoprost or Rhopressa™ throughout the duration of the study • There were no drug-related serious adverse events and no evidence of treatment-related systemic effects • The main adverse event was conjunctival hyperemia, ~50% of patients and was scored as mild for ~80% of these patients Next Steps: • Mercury 2: Topline 3-month expected H1 2017 • Mercury 3 (Europe): Efficacy study, comparing to a leading combo product marketed in Europe, expected to commence in H1 2017 • Roclatan TM NDA filing expected near year-end 2017 Aerie will present additional details at Investor Day in NYC, Oct 5 18 |
2016 2017 Rhopressa TM and Roclatan TM Key Milestones Q3-2017: Roclatan™ P3 Mercury 1 Topline safety (12 mos) Near YE 2017: Roclatan™ NDA filing expected 1H-2017: Roclatan™ P3 Mercury 3 (EU) to be initiated Q1-2016: Rhopressa™ Rocket 2 Topline safety (12 mos) Q3-2016: Rhopressa™ NDA filed Q4-2016: Rhopressa™ Rocket 4 Topline efficacy (3 mos) Q3-2016: Roclatan™ P3 Mercury 1 Topline efficacy (3 mos) Q2-2017: Roclatan™ P3 Mercury 2 Topline efficacy (3 mos) Q1-2016: Roclatan™ P3 Mercury 2 initiated 19 |