psivida transforms into commercial stage …transforming into a commercial stage specialty...

20
pSivida Transforms into Commercial Stage Specialty BioPharmaceutical Company NASDAQ: EYPT OIS @ AAO October 25, 2018

Upload: others

Post on 22-May-2020

1 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

pSivida Transforms intoCommercial Stage SpecialtyBioPharmaceutical Company

NASDAQ: EYPT

OIS @ AAOOctober 25, 2018

Page 2: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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.

2

Page 3: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

EyePoint Transforms into a Commercial Stage Organization

3

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

Page 4: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

Transforming Into a Commercial Stage Specialty Biopharmaceutical Company

4

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

Page 5: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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

Page 6: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

Post-CataractSurgery Inflammation

6

Page 7: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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

Page 8: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA
Page 9: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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)

**

*

Page 10: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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.

Page 11: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

DEXYCU™ (dexamethasone intraocular suspension) 9% Placebo-controlled Phase 3 Clinical Study – IOP Levels

11

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

Page 12: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

DEXYCU – Targeting Inflammation from within

12

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

Page 13: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

13

Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye

FDA Approved 10/12/18

Page 14: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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

Page 15: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Efficacy Endpoint: Uveitis Recurrence Rates (US Analysis)

15

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)

Page 16: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

YUTIQ 12 Month Cumulative Recurrence Rates

Presented at ASRS 2018: Dr Quan Nguyen

Page 17: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

YUTIQ Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Mean IOP Elevation and Cataract Surgery at 12 Months

17

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

Page 18: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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

18

Page 19: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

YUTIQ – Three Year Intravitreal Implant for Chronic Noninfectious Posterior Uveitis

19

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

Page 20: pSivida Transforms into Commercial Stage …Transforming Into a Commercial Stage Specialty Biopharmaceutical Company 4 YUTIQ FDA Approved 10/12/18 YUTIQ Posterior Segment Uveitis NDA

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

20

Postoperative inflammation following

cataract surgery

Treatment of chronic non-infectious uveitis affecting

the posterior segment