psivida Transforms into Commercial Stage Specialty BioPharmaceutical Company AAO October 25, 2018 NASDAQ: EYPT

Transcription

1 psivida Transforms into Commercial Stage Specialty BioPharmaceutical Company AAO October 25, 2018 NASDAQ: EYPT

2 Forward Looking SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. This presentation is intended for communication for investors only. Nothing in this presentation should be construed as promoting the use of Dexycu or product candidates. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema ("DME"), which depends on Alimera's ability to continue as a going concern; Alimera's ability to obtain marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN; the number of clinical trials and data required for the Durasert technology for the treatment of non-infectious uveitis affecting the posterior segment of the eye, uveitis marketing application approval in the U.S.; our ability to use data in promotion for Durasert micro insert for the treatment of non-infectious uveitis affecting the posterior segment of the eye, U.S. NDA approval which includes clinical trials outside the U.S. U.S. NDA including clinical trials outside the U.S.; our ability to successfully commercialize DEXYCU in the U.S.; our ability to obtain stockholder approval for portions of the EW and SWK investments; our ability to successfully commercialize Durasert three-year uveitis, if approved, in the U.S.; potential off-label sales of ILUVIEN for uveitis; consequences of fluocinolone acetonide side effects; the development of our next-generation Durasert shorter-duration treatment for posterior segment uveitis; potential declines in Retisert royalties; efficacy and the future development of an implant to treat severe osteoarthritis; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements, including our agreement with Alimera; termination or breach of current license agreements, including our agreement with Alimera; our dependence on contract research organizations, vendors and investigators; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; effects of the potential U.K. exit from the EU; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized. 2

3 EyePoint Transforms into a Commercial Stage Organization Two potential near-term innovative ophthalmology launches Acquisition of Icon Bioscience has accelerated growth Postoperative inflammation following cataract surgery DURASERT Approved Capital infusion of over $80M in 2018 from EW Healthcare, SWK and other accredited investors validates business Technology model Strategy to expand ophthalmic portfolio Treatment of chronic noninfectious uveitis affecting the posterior segment 3 Strong leadership team with seasoned executives at the helm

4 Transforming Into a Commercial Stage Specialty Biopharmaceutical Company YUTIQ Posterior Segment Uveitis NDA accepted by FDA 3/19/18 Secured passthrough reimbursement for DEXYCU TM on 9/5/18 Transformative acquisition of Icon Bioscience Inc on 3/28/18 added DEXYCU Planned launches of DEXYCU TM and YUTIQ TM * in first half of 2019 YUTIQ FDA Approved 10/12/18 4

5 EyePoint Pharmaceuticals' Product Pipeline 100% Ophthalmology Focus 2 FDA Approved Products Product Preclinical Phase 1 Phase 2 Phase 3 Filing DEXYCU (dexamethasone intraocular suspension) 9% YUTIQ three-year treatment for posterior-segment uveitis YUTIQ shorter-duration treatment for posterior-segment uveitis Durasert TKI for wet AMD Collaboration on glaucoma Verisome Technology PGE potential indication: glaucoma Verisome Technology NSAID potential indication: cataract surgery inflammation

6 6 Post-Cataract Surgery Inflammation

7 DEXYCU Uses Verisome Technology to Deliver 517 μg of Dexamethasone1 Administered as a single dose of 5-µL, intraocularly into the posterior chamber inferiorly behind the iris at the end of ocular surgery Formulated in the fully bioerodible Verisome technology 7 Source: Wong V. et al. Pharmacokinetic Study of in the Anterior Chamber of Rabbits (2013). Data on file. Refer to the full DEXYCU product label at

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9 DEXYCU TM Rapidly Reduces Inflammation as Early as Day 1 with Statistical Significance at Day 3 through Day % Patients with ACC Clearing at Each Visit Proportion of Patients (%) 90% 80% 70% 60% 50% 40% 30% 20% 15% 28% * * 60% 58% 10% 9% 16% 20% 0% Day 8 Primary Postoperative Day endpoint *P 0.05 vs placebo DEXYCU [package insert]. EyePoint Pharmaceuticals % * 66% 35% * DEXYCU (n=156) Placebo (n=80)

10 DEXYCU (dexamethasone intraocular suspension) 9% Overall Clinical Trial Experience Safety Adverse event rates derived from three clinical trials (including 339 patients receiving the 517 μg dose [DEXYCU]): The most commonly reported adverse reactions, occurring in 5% to 15% of subjects, included increases in intraocular pressure (IOP), corneal edema, and iritis. Other ocular adverse reactions, occurring in 1% to 5% of subjects, included corneal endothelial cell loss, blepharitis, eye pain, cystoid macular edema, dry eye, ocular inflammation, posterior capsule opacification, blurred vision, reduced visual acuity, vitreous floaters, foreign body sensation, photophobia, and vitreous detachment. 10 DEXYCU [package insert]. EyePoint Pharmaceuticals. May 2018.

11 DEXYCU (dexamethasone intraocular suspension) 9% Placebo-controlled Phase 3 Clinical Study IOP Levels IOP Intervals on POD 1 IOP Intervals on POD 3 % of patients 100% 80% 60% 40% 20% 0% 90.1% 76.7% 12.3% 3.8% 5.2% 5.1% 5.8% 1.3% < 25 mm Hg mm Hg mm Hg 35 mm Hg % of patients 100% 80% 60% 40% 20% 0% 100.0% 98.0% 0.0% 0.6% 0.0% 1.3% 0.0% < 25 mm Hg mm Hg mm Hg 35 mm Hg IOP Intervals on POD 8 IOP Intervals on POD 15 % of patients 100% 80% 60% 40% 20% 0% 100.0% 98.0% 0.0% 1.9% 0.0% 0.0% < 25 mm Hg mm Hg mm Hg 35 mm Hg % of patients 100% 80% 60% 40% 20% 0% 100.0% 0.0% 0.0% 0.0% < 25 mm Hg mm Hg mm Hg 35 mm Hg placebo DEXYCU 11 Data on file. Phase III Study Post hoc analysis.

12 DEXYCU Targeting Inflammation from within The FIRST and ONLY FDA-approved, single dose, sustained release, intracameral steroid for the treatment of postoperative inflammation Postoperative inflammation following cataract surgery Targeted anti-inflammatory steroid treatment provides Complete anterior chamber cell clearing started as early as day1 and continued through day 30 3X more DEXYCU patients had complete AC clearing vs placebo DURASERT at day 8 More than half of all DEXYCU patients did NOT require additional Approved antiinflammatory medication during the study Technology Uses patented Verisome technology - First-in-class sustained release drug delivery system Helps put control in place with a single dose before patients leave the surgical suite 12

13 Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye FDA Approved 10/12/18 13

14 EyePoint has Over 20 Years of Heritage in Ocular Drug Delivery EyePoint has developed four products approved by the FDA for long-term, sustained-release delivery of drug Approved 2012 Approved 2018 Approved 2005 Approved 1996 Vitrasert CMV retinitis 14 Retisert Uveitis Iluvien DME Approved Durasert technology products developed by EyePoint (formerly psivida)

15 YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Efficacy Endpoint: Uveitis Recurrence Rates (US Analysis) Patients with Uveitis Recurrence at 12 Months Study -001 Study Patients (%) Patients (%) Month Recurrence 0 12-Month Recurrence 15 YUTIQ (n = 87) Sham (n = 42) P < for both studies YUTIQ (n=101) Sham (n=52)

16 YUTIQ 12 Month Cumulative Recurrence Rates Presented at ASRS 2018: Dr Quan Nguyen

17 YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Mean IOP Elevation and Cataract Surgery at 12 Months Mean IOP Elevation: Month 12 vs. Baseline Cataract Surgery Through 12 Months [phakic eyes only] mm Hg n = 84 n = PSV-FAI-001 YUTIQ Δ = 1.1 mm Hg Sham n = 93 n = 49 PSV-FAI-005 Δ = 2.0 mm Hg Percentage / / PSV-FAI-001 YUTIQ Sham 11/ / PSV-FAI

18 YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Safety: Other Adverse Events Event YUTIQ (N=188) n (%) Sham (N=94) n (%) Visual Acuity Reduced 22 (11.7) 10 (10.6) Macular Edema 1 21 (11.2) 30 (31.9) Uveitis 17 (9.0) 28 (29.8) Conjunctival Hemorrhage 15 (8.0) 5 (5.3) Hypotony of the Eye 2 15 (8.0) 1 (1.1) Eye Pain 3 15 (8.0) 10 (10.6) Anterior Chamber Cell 10 (5.3) 4 (4.3) Dry Eye 10 (5.3) 2 (2.1) 1 includes macular edema and cystoid macular edema 2 includes hypotony, intraocular pressure decreased and procedural hypotension 3 includes eye pain and procedural pain 18

19 YUTIQ Three Year Intravitreal Implant for Chronic Noninfectious Posterior Uveitis YUTIQ delivers uninterrupted, 3 year fluocinolone delivery for patients with chronic noninfectious posterior uveitis YUTIQ was rigorously studied in two pivotal trials Treatment of chronic noninfectious uveitis affecting the posterior segment FDA Approved 10/12/18 19 Proven to significantly reduce uveitis recurrence at 6 and 12 months Uveitis recurrence rates decreased by as much as 77% at 6 months, and 68% at 12 months Analyses of the rate of uveitis reduction at 236 months are ongoing YUTIQ significantly extended the time to first recurrence of uveitis

20 EyePoint Transforms into a Commercial Stage Organization Positioned for Commercial Success Ø Potential for Two innovative Ophthalmology Product Launches in 1H 2019 Postoperative inflammation following cataract surgery Ø Capital infusion of over $80M in 2018 from EW Healthcare, SWK and other accredited investors validates business model Ø Seasoned Ophthalmic Leadership Team with Numerous Successful Launches Treatment of chronic noninfectious uveitis affecting the posterior segment VP of Marketing and Sales VP of Medical Affairs VP of Market Access Ø Premier Contract Sales Organization hired Dedicated team with deep ophthalmology experience 20