Full Press Release Details
1 | EYEPOINT PHARMACEUTICALS Delivering Innovation to the Eye Investor Presentation January 2022 Exhibit 99.1
Various statements made in this presentation are forward-looking, within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about our expectations regarding the potential benefits of our partnerships and strategic alliances with other companies, as well as the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a vital, novel twice-yearly treatment for wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; and our longer term financial and business goals and expectations, 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 are risks and uncertainties inherent in our business including, without limitation: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the extent to which COVID-19 impacts our business; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; 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; volatility of our stock price; possible dilution; absence of dividends; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. 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. Forward looking statements
Pipeline leveraging proven Durasert technology * Compelling pipeline focused on retinal disease
EYP-1901 - advancing into phase 2 trials for wet AMD, diabetic retinopathy (DR), and retinal vein occlusion (RVO) after positive phase 1 interim results and positive Type C FDA meeting guidance
Additional molecules and MOAs under evaluation
Durasert - proven intravitreal (IVT) drug delivery platform
Sustained local drug delivery
Constant (zero-order kinetics), stable release of drug in the eye over weeks, months or years
Safely administered to thousands of patients' eyes across four FDA approved products
Commercial franchises - YUTIQ and DEXYCU
Positioned to break-even in 2022 as stand-alone franchise
YUTIQ 50 in Phase 3 study supporting an sNDA filing
DEXYCU sales and marketing now managed by commercial partner ImpriminsRx as we focus on retina
3 | EYEPOINT PHARMACEUTICALS *non-erodible
5 | EYEPOINT PHARMACEUTICALS DURASERT Proven sustained release intravitreal drug delivery PLATFORM TECHNOLOGY 4 | EYEPOINT PHARMACEUTICALS
DURASERT Proven safe, sustained intravitreal delivery Delivered by a simple, single in-office intravitreal injection
Continuous, stable release provides consistent and reliable drug delivery over weeks, months, or years Approved Products
YUTIQ (2018, EyePoint) Posterior Segment Uveitis
ILUVIEN (2014, Alimera) - DME
RETISERT (2005, B&L) - Uveitis
VITRASERT (1996, B&L) - CMV retinitis Development Candidates
Diabetic Retinopathy (DR)
Retinal Vein Occlusion (RVO)
Posterior Segment Uveitis
5 | EYEPOINT PHARMACEUTICALS
6 | EYEPOINT PHARMACEUTICALS Retinal disease focused pipeline
EYP-1901 - IVT delivery of vorolanib using bioerodible Durasert as a potential six-month treatment Our goal is nothing short of transforming the treatment of wet AMD, diabetic retinopathy, and retinal vein occlusion PIPELINE 7 | EYEPOINT PHARMACEUTICALS
EYP-1901 RETROSPECTIVE STUDY OF 3350 RANIBIZUMAB AND 4300 AFLIBERCEPT TREATMENT-NAIVE EYES WITH WET AMD 8 | EYEPOINT PHARMACEUTICALS Real World Reality - Even One Missed Injection Can Mean Loss of Vision Study evaluated 1,041 pts getting intravitreal anti-VEGF therapies
60% went to scheduled follow up - 40% did not
Conclusion: With frequent injections required for current standard of care, a delay in care of only 5.34 weeks resulted in visual loss
Sustained release options may give practitioners and patients improved outcomes
Bioerodible Durasert :
Similar technology used in YUTIQ , Retisert , and Vitrasert
Polyimide shell removed (used for 3-year duration)
Bioerodible core matrix remains
Initial burst from the surface of implant
Constant, zero-order kinetic release rate for months EYP-1901 - A Novel Approach to Wet AMD Therapy Vorolanib in Bioerodible Durasert 9 | EYEPOINT PHARMACEUTICALS vorolanib
Receptor-binding, small molecule tyrosine kinase inhibitor (TKI)
Activity against all isoforms of VEGF and PDGF
Oral vorolanib previously studied in a wet AMD ph1 and ph2 programs1,2 Jackson et al. JAMA Ophthalmol 2017
Cohen MN et al. Br J Ophthalmol. 2021
23 | EYEPOINT PHARMACEUTICALS Effective blocking of VEGFR Prevents Exudation and Loss of Vision PIPELINE
EYP-1901 VEGF-B VEGF-C VEGF-D VEGF-A R1 / INFLAMMATION R2 / BLOOD VESSEL LEAKAGE R3 / BLOOD VESSEL GROWTH & LEAKAGE VEGF SIGNALING PATHWAYS VOROLANIB 10 | EYEPOINT PHARMACEUTICALS Approved
Anti-VEGF-A therapies VOROLANIB VOROLANIB
EYP-1901 - Intellectual Property Overview 11 USFDA Exclusivity
Potential 5 years for new chemical entity or 3 years for new clinical investigation
In-Licensed Patents and Applications
US patents expiring in 2027
US patent expiring in 2037, and related pending US application
Ex-US patents and pending patent applications
EyePoint Patent Applications
International Patent Application (PCT) filed in September 2021
US provisional application filed in October 2021
EYP-1901 phase 1 trial interim results 12 | EYEPOINT PHARMACEUTICALS
6-month interim data summary: All study objectives successfully met Positive safety data:
No ocular Serious Adverse Events (SAEs) reported
No drug-related systemic SAEs reported
All ocular AEs were < grade 2; the only grade 3 AE was not drug-related EFFICACY Positive efficacy Data:
Median time to rescue: 6 months
Clinically significant reduction in treatment burden SAFETY 13 | EYEPOINT PHARMACEUTICALS EYP-1901 -DAVIO Phase 1 Study in Wet AMD
"Durasert and Vorolanib in Ophthalmology"
NO mandated EYP 1901 retreatments
Criteria for rescue anti-VEGF therapy*:
New fluid > 75 microns (OCT) compared to Day-0
2 lines of BCVA secondary to wet AMD compared to Day-0
New macular hemorrhage secondary to wet AMD
Previously treated wet AMD eyes only
No exclusion for presence of fluid
Primary endpoint: safety
Full readout at month-12
Secondary endpoints:
CST as measured by OCT
Note: All doses delivered in a single intravitreal injection.
BCVA: best corrected visual acuity; OCT: optical coherence tomography; CST: central subfield thickness
14 | EYEPOINT PHARMACEUTICALS EYP-1901 - DAVIO Phase 1 Study in Wet AMD Open label, Dose Escalation, No Control Arm *at the discretion of the investigator Screening visit SOC Injection EYP 1901 7 - 10 days later Low Dose (440 g) N=3 Low-Mid Dose (1030 g) N=1 Mid Dose (2060 g) N=8 High Dose (3090 g) N=5 RESULTS Month-12 Full Read Day 0 Month 1 Month 2 Month 3 Month 4 Month 5 RESULTS Month 6 Interim data Month 7 Month 8 Month 9 Month 10 Month 11 Month 12
BCVA: best corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; CST: central subfield thickness 15 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study
Participants and 6-month Follow-Up
16 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study
6-Month Results: Safety
No other reported significant adverse events such as:
No vitreous floaters
No retinal detachment
No implant migration in the anterior chamber
No retinal vasculitis
No posterior segment inflammation
AC, anterior chamber; AE, adverse event; BCVA, best corrected visual acuity; SAE, serious adverse event Positive overall safety data
No ocular serious adverse events (SAEs) reported
No drug-related systemic SAEs reported
One eye: mild asymptomatic anterior chamber cell/flare; Treated with Maxitrol eyedrops - resolved in 8 days -no sequelae or recurrence
One eye: asymptomatic vitreous hemorrhage from injection; Observed 17 | EYEPOINT PHARMACEUTICALS EYP-1901 - Phase 1 DAVIO Study
Primary Endpoint - Safety at 6 months
a. All mild-to-moderate in severity and determined not related to study drug
b. Grade 1/Mild AEs of particular interest AC anterior chamber; AE, adverse event; BCVA, best corrected visual acuity; OS, left eye; OU; both eyes 18 | EYEPOINT PHARMACEUTICALS EYP-1901 - Phase 1 DAVIO Study
Summary at 6 Months - Ocular Safety
19 | EYEPOINT PHARMACEUTICALS EYP-1901 Phase 1 DAVIO Study
6 Month Results: visual acuity, CST, rescue free rates, and reduction in treatment burden
EYP-1901 - Phase 1 DAVIO Study Average Visual Acuity (VA) Stable 6 Months After Treatment 20 BCVA: best corrected visual acuity Interim data - monitored through 6 months For all 17 eyes at 6 months
OCT: optical coherence tomography; CST: central subfield thickness
Interim data - monitored through 6 months 21 | EYEPOINT PHARMACEUTICALS EYP-1901 - Phase 1 DAVIO Study
Central Subfield Thickness (CST) Sustainable Anatomical Control & Efficacy For all 17 eyes at 6 months