Post on 22-May-2020
pSivida Transforms intoCommercial Stage SpecialtyBioPharmaceutical Company
NASDAQ: EYPT
OIS @ AAOOctober 25, 2018
Forward LookingSAFE 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.
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EyePoint Transforms into a Commercial Stage Organization
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DURASERT™Approved
Technology
Acquisition of Icon Bioscience has accelerated growth
Two potential near-term innovative ophthalmology launches
Strong leadership team with seasoned executives at the helm
Strategy to expand ophthalmic portfolio
Capital infusion of over $80M in 2018 from EW Healthcare, SWK and other accredited investors validates business model
Postoperative inflammation following
cataract surgery
Treatment of chronic non-infectious uveitis affecting
the posterior segment
Transforming Into a Commercial Stage Specialty Biopharmaceutical Company
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YUTIQ™ FDA Approved
10/12/18
YUTIQ™ Posterior Segment Uveitis NDA accepted by
FDA 3/19/18
Transformative acquisition of Icon
Bioscience Inc on 3/28/18 added DEXYCU™
Planned launches of DEXYCUTM and
YUTIQTM* in first half of 2019
Secured pass-through
reimbursement for DEXYCUTM on 9/5/18
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
EyePoint Pharmaceuticals' Product Pipeline – 100% Ophthalmology Focus – 2 FDA Approved Products
Post-CataractSurgery Inflammation
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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
7Source: Wong V. et al. Pharmacokinetic Study of 10090 in the Anterior Chamber of Rabbits (2013). Data on file.Refer to the full DEXYCU™ product label at www.eyepointpharma.com
DEXYCUTM Rapidly Reduces Inflammation as Earlyas Day 1 with Statistical Significance at Day 3 through Day 30
9% 16%20%
26%
35%15%
28%
60% 58%66%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
Prop
ortio
n of
Pat
ient
s (%
)
Postoperative Day
Patients with ACC Clearing at Each Visit
DEXYCU™ [package insert]. EyePoint Pharmaceuticals. 2018.
*
*P≤0.05vsplacebo
Day8Primaryendpoint
Placebo(n=80)
DEXYCU™(n=156)
**
*
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.
DEXYCU™ (dexamethasone intraocular suspension) 9% Placebo-controlled Phase 3 Clinical Study – IOP Levels
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90.1%
3.8% 1.3% 5.1%
76.7%
12.3% 5.2% 5.8%
0%
20%
40%
60%
80%
100%
< 25 mm Hg 25-29 mm Hg 30-34 mm Hg ≥ 35 mm Hg
IOP Intervals on POD 1100.0%
0.0% 0.0% 0.0%
98.0%
0.6% 1.3% 0%
20%
40%
60%
80%
100%
< 25 mm Hg 25-29 mm Hg 30-34 mm Hg ≥ 35 mm Hg
IOP Intervals on POD 3
100.0%
0.0% 0.0% 0.0%
98.0%
1.9% 0%
20% 40% 60% 80%
100%
< 25 mm Hg 25-29 mm Hg 30-34 mm Hg ≥ 35 mm Hg
IOP Intervals on POD 8100.0%
0.0% 0.0% 0.0% 0%
20% 40% 60% 80%
100%
< 25 mm Hg 25-29 mm Hg 30-34 mm Hg ≥ 35 mm Hg
IOP Intervals on POD 15
placebo
DEXYCU
Data on file. Phase III Study 13-04. Post hoc analysis.
% o
f pat
ient
s
% o
f pat
ient
s
% o
f pat
ient
s
% o
f pat
ient
s
DEXYCU – Targeting Inflammation from within
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DURASERT™Approved
Technology
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 at day 8• More than half of all DEXYCU patients did NOT require additional anti-
inflammatory medication during the study
The FIRST and ONLY FDA-approved, single dose, sustained release, intracameral steroid for the treatment of postoperative inflammation
Helps put control in place with a single dose before patients leave the surgical suite
Uses patented Verisome technology - First-in-class sustained release drug delivery system
Postoperative inflammation following cataract surgery
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Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye
FDA Approved 10/12/18
EyePoint has Over 20 Years of Heritage in Ocular Drug Delivery
14 Approved Durasert™ technology products developed by EyePoint (formerly pSivida)
EyePoint has developed four products approved by the FDA for long-term, sustained-release delivery of drug
Retisert®Uveitis
Approved 2005
Vitrasert®CMV retinitis
Approved 1996 Iluvien®
DME
Approved 2012Approved 2018
YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Efficacy Endpoint: Uveitis Recurrence Rates (US Analysis)
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27.6
85.7
0102030405060708090
100
12-Month Recurrence
Patie
nts
(%)
Study -001
YUTIQ (n = 87) Sham (n = 42) P < 0.001 for both studies
Patients with Uveitis Recurrence at 12 Months
32.7
59.6
0102030405060708090
100
12-Month Recurrence
Patie
nts
(%)
Study -005
YUTIQ (n=101) Sham (n=52)
YUTIQ 12 Month Cumulative Recurrence Rates
Presented at ASRS 2018: Dr Quan Nguyen
YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Mean IOP Elevation and Cataract Surgery at 12 Months
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Perc
enta
ge
mm
Hg
1.3
2.0
0.2 0.00.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
PSV-FAI-001 PSV-FAI-005
Mean IOP Elevation:Month 12 vs. Baseline
YUTIQ Sham
n = 84 n = 39
Δ = 1.1 mm Hg
n = 93 n = 49
Δ = 2.0 mm Hg
33.3
18.0
4.88.6
05
101520253035404550
PSV-FAI-001 PSV-FAI-005
Cataract Surgery Through 12 Months [phakic eyes only]
YUTIQ Sham
14/42
1/21
11/61
3/35
EventYUTIQ
(N=188) n (%)Sham
(N=94) n (%)Visual Acuity Reduced 22 (11.7) 10 (10.6)Macular Edema1 21 (11.2) 30 (31.9)Uveitis 17 (9.0) 28 (29.8)Conjunctival Hemorrhage 15 (8.0) 5 (5.3)Hypotony of the Eye2 15 (8.0) 1 (1.1)Eye Pain3 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 edema2 includes hypotony, intraocular pressure decreased and procedural hypotension3 includes eye pain and procedural pain
YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005Safety: Other Adverse Events
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YUTIQ – Three Year Intravitreal Implant for Chronic Noninfectious Posterior Uveitis
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YUTIQ™ delivers uninterrupted, 3 year fluocinolone delivery for patients with chronic noninfectious posterior uveitis
YUTIQ™ was rigorously studied in two pivotal trials• 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 on-
going
YUTIQ significantly extended the time to first recurrence of uveitis
Treatment of chronic non-infectious uveitis affecting the
posterior segment
FDA Approved 10/12/18
Positioned for Commercial Success Ø Potential for Two innovative Ophthalmology Product Launches
in 1H 2019
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
• 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
EyePoint Transforms into a Commercial Stage Organization
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Postoperative inflammation following
cataract surgery
Treatment of chronic non-infectious uveitis affecting
the posterior segment