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8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): October 15, 2018

 

 

EyePoint Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-51122   26-2774444

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

480 Pleasant Street

Watertown, MA

   02472
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 926-5000

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 

Item 8.01.

Other Events.

On October 15, 2018, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration approved YUTIQ™ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated by reference herein.

On October 15, 2018, the Company also posted an updated corporate presentation on its website at www.eyepointpharma.com. A copy of the presentation is filed herewith as Exhibit 99.2 and is incorporated by reference herein.

 

Item 9.01.

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

    No.    

   

Description

99.1    Press release of EyePoint Pharmaceuticals, Inc. dated October 15, 2018.
99.2    Corporate Presentation, dated October 15, 2018.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    EYEPOINT PHARMACEUTICALS, INC.
Date: October 15, 2018     By:  

/s/ Nancy Lurker

    Name:   Nancy Lurker
    Title   President and Chief Executive Officer
EX-99.1

Exhibit 99.1

 

LOGO

EyePoint Pharmaceuticals Receives FDA Approval of YUTIQ™ (fluocinolone acetonide intravitreal implant) 0.18 mg

- The first long-lasting, FDA approved micro-insert for up to three years of continuous control in chronic, non-infectious posterior segment uveitis, the third leading cause of blindness in the U.S.

- Company to host conference call today at 8:30 a.m. ET

WATERTOWN, Mass., October 15, 2018 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products, announced today that the U. S. Food and Drug Administration (FDA) has approved YUTIQ™ (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. YUTIQ utilizes the Company’s Durasert™ drug delivery technology and is a non-bioerodible intravitreal micro-insert in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release consistently over 36 months. YUTIQ is supplied in a sterile single-dose preloaded applicator that can be administered in the physician’s office. In clinical trials, YUTIQ significantly reduced the rate of recurrent uveitis flares versus sham, and the most common adverse reactions reported were cataract development and increase in intraocular pressure (IOP).

“The approval of YUTIQ by the FDA is a significant milestone achieved by the Company and marks the second approved ophthalmic product in our pipeline that we plan to commercialize ourselves in the U.S.,” said Nancy Lurker, EyePoint’s President and Chief Executive Officer. “YUTIQ was developed internally by our research team and this approval further validates our capabilities to successfully design, develop and gain regulatory approval for an ophthalmology product to address a disease with high unmet need. Chronic non-infectious uveitis affecting the posterior segment of the eye is the third leading cause of blindness in the U.S. We anticipate a product launch in the first quarter of calendar 2019 and look forward to bringing this innovative treatment to patients suffering from this disease.”

“The approval of YUTIQ is an advancement in the treatment of non-infectious posterior segment uveitis, as it delivers consistent dosing without the peaks and valleys of current local corticosteroids, the standard of care. The clinical data have demonstrated that

YUTIQ has a meaningful effect to lower recurrence rates at six and twelve-months following treatment. I believe the effect on recurrence rates will be highly beneficial to help to prevent secondary complications that can lead to vision loss. The approval of YUTIQ is an important step forward for patients and caregivers,” said Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine.

The FDA approved YUTIQ based on clinical data from two randomized, sham injection-controlled, double-masked Phase 3 clinical trials with patient follow-up continuing for three years. After six and 12 months, both clinical trials achieved the primary efficacy endpoint of prevention of recurrent uveitis flares. Although the p-value of less than 0.001 was reported in each clinical trial, the Company will be using a p-value of 0.01 which is reflected in YUTIQ’s label.

The first Phase 3 clinical trial met its primary efficacy endpoint at six months with statistical significance (p < 0.01, intent-to-treat analysis; recurrence of 18.4% for YUTIQ versus 78.6% for control). This trial yielded similar efficacy through 12 months of follow-up (p < 0.01, intent-to-treat analysis; recurrence of 27.6% for YUTIQ versus 85.7% for control). YUTIQ was generally well tolerated through 12 months of follow-up with a mean IOP elevation of 1.3 mmHg compared to 0.2 mmHg in the sham. Cataract surgeries were performed in 33.3% of patients receiving YUTIQ compared to 4.8% for sham.

The second Phase 3 clinical trial also met its primary efficacy endpoint of prevention of recurrence of uveitis flares at six months with statistical significance (p < 0.01, intent-to-treat analysis; recurrence of 21.8% for YUTIQ versus 53.8% for control). 12-month recurrence occurred in 32.7% of patients receiving YUTIQ and 59.6% of those receiving sham injection (p<0.01, intent-to-treat analysis). As observed in the first Phase 3 clinical trial, YUTIQ was well tolerated with a mean IOP elevation of 2.0 mmHg compared to no change in the sham. Cataract surgeries were performed in 18.0% of patients receiving YUTIQ compared to 8.6% for sham.

The 24-month and 36-month patient follow-up from the first Phase 3 clinical trial of YUTIQ is expected to be reported by the end of calendar 2018 and in the first half of calendar 2019, respectively.

EyePoint is also developing a next-generation, shorter-duration treatment for chronic non-infectious uveitis affecting the posterior segment of the eye, based on the Durasert technology. This insert is designed to offer a shorter delivery period, thus providing physicians with flexibility for multiple dosing intervals. The Company plans to file an application for approval of this insert in 2019. In addition, the Company intends to launch DEXYCUTM for the treatment of post-operative inflammation at the end of cataract surgery, in the first half of calendar 2019.

Conference Call Information

EyePoint will host a conference call today, Monday, October 15, 2018, at 8:30 a.m. ET, to discuss the U.S. approval of YUTIQ. To access the conference call, please dial (877) 312-7507 (local) or (631) 813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 2887269. A live webcast will be available on the Investor Relations section of the corporate website at http://www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

YUTIQTM Label & Important Safety Information

YUTIQ™ (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

In controlled clinical trials, the most common adverse reactions reported were cataract development and increase in intraocular pressure.

YUTIQ is contraindicated in patients with known hypersensitivity to any components of this product, and is also contraindicated in patients with active or suspected ocular or periocular infections, including most viral diseases of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections and fungal diseases.

About Chronic Non-infectious Uveitis Affecting the Posterior Segment of the Eye

Non-infectious posterior segment uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is believed to be a leading cause of blindness globally. It affects people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S., posterior segment uveitis is estimated to affect between 55,000 - 120,000 people resulting in approximately 30,000 cases of blindness, making it the third leading cause of blindness in the U.S. Today, patients with posterior uveitis are typically treated with systemic steroids, but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals, Inc. (formerly pSivida Corp.) (www.eyepointpharma.com), headquartered in Watertown, MA, is a specialty biopharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. With the approval of YUTIQTM, the Company has developed four of only five FDA-approved sustained-release treatments for back-of-the-eye diseases. In addition, DEXYCU™ was approved by the FDA on February 9, 2018. DEXYCU, administered as a single intraocular dose at the end of ocular surgery for the treatment of postoperative inflammation, is the first and only FDA-approved intraocular product with this indication. DEXYCU employs the Verisome® extended-release drug delivery technology, which encompasses a broad number of related, but distinct drug delivery systems capable of incorporating an extensive range of active agents, including small molecules, proteins and monoclonal antibodies. ILUVIEN® (fluocinolone acetonide intravitreal implant), a micro-insert for diabetic macular edema, licensed to Alimera Sciences, Inc., is currently sold directly in the U.S. and several EU countries. Retisert® (fluocinolone acetonide intravitreal implant), for posterior uveitis, is licensed to and sold by Bausch & Lomb, Inc. YUTIQ three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye is approved by the U.S. FDA. The Company’s pre-clinical development program is focused on using its core Durasert™ and the Verisome platform technologies to deliver drugs to treat wet age-related macular degeneration, glaucoma, and other diseases. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter, LinkedIn, Facebook and Google+.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: Various statements made in this release are forward-looking, 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 plans to commercialize YUTIQ and DEXYCU, the expected timing of release of the 24-month and 36-month patient follow-up data for YUTIQ and our expectations regarding the timing of a filing of an application for approval of a next-generation, shorter-duration treatment for posterior segment uveitis, 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; our ability to successfully produce commercial supply of YUTIQ and DEXYCU and commercialize YUTIQ and DEXYCU in the U.S.; our ability to successfully build a commercial infrastructure and enter into and maintain commercial

agreements for the launch of DEXYCU and YUTIQ; the development of our next-generation YUTIQ short-acting treatment for uveitis; potential off-label sales of ILUVIEN for non-infectious posterior segment uveitis (“NIPU”); consequences of fluocinolone acetonide side effects; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema (“DME”) which depends on the ability of Alimera Sciences, Inc. (“Alimera”) to continue as a going concern; Alimera’s ability to obtain additional marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; Alimera’s ability to obtain marketing approval for ILUVIEN in its licensed territories for NIPU; potential declines in Retisert royalties; 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, contract sales 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 exit of the United Kingdom from the European Union; 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.

Contacts

Investors:

Argot Partners

Kimberly Minarovich

(646) 368-8014

kimberly@argotpartners.com

Joseph Rayne

(617) 340-6075

joseph@argotpartners.com

Media:

Thomas Gibson

201-476-0322

tom@tomgibsoncommunications.com

EX-99.2

Slide 0

NASDAQ: EYPT Investor Presentation October 2018 Exhibit 99.2

Slide 1

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.

Slide 2

Acquired Icon Bioscience to transform business and accelerate growth Two ophthalmology launches in 1H 2019 Strong leadership team with seasoned executives at the helm Executing on strategy to expand ophthalmology portfolio and utilize existing platform Obtained $80M+ in capital from new institutional investors Posterior segment uveitis Postoperative inflammation following cataract surgery EyePoint Highlights Transformational Opportunity in Ophthalmology

Slide 3

Management with Proven Commercial Track Record and Highly Experienced Board of Directors Göran Ando, M.D. Chairman of the Board Dr. David J Mazzo Director Nancy Lurker President and CEO Michael W Rogers Director Doug Godshall Director Dr. Jay Duker Director Kristine Peterson Director Ron Eastman Director Board of Directors Nancy Lurker President and CEO David Price Chief Financial Officer Dario Paggiarino, M.D. Chief Medical Officer Jack Weet, Ph.D. SVP, Regulatory Affairs & Quality

Slide 4

Transforming Into a Commercial Stage Specialty Biopharmaceutical Company YUTIQ™ Approved by FDA for Posterior Segment Uveitis on 10/12/18 Transformative acquisition of Icon Bioscience Inc on 3/28/18 added DEXYCU™ (approved by FDA on 2/9/18) to pipeline. EW and other investors commit total proceeds of $80M+, tranched over several months. All now received. Planned launch of YUTIQTM* in first quarter of 2019 Secured pass-through reimbursement for DEXYCUTM on 9/5/18 Planned launch of DEXYCUTM in first half of 2019 `

Slide 5

EyePoint Pharmaceuticals' Product Pipeline Product / Program Preclin. Phase 1 Phase 2 Phase 3 Approval Market Rights DEXYCU™ post-operative inflammation 1H 2019 Launch WW YUTIQ™ three-year treatment for posterior segment uveitis 1Q 2019 Launch U.S.(1) YUTIQ™ shorter duration treatment for posterior segment uveitis Reg filing in 2019 WW Durasert™ TKI wet AMD WW Verisome® technology – PGE glaucoma WW Verisome® technology – NSAID cataract surgery inflammation WW ILUVIEN®, RETISERT® Royalties Partners(1)(2) Collaborations Partners(3) C-Code Received J-Code Available Alimera Sciences, Inc. owns worldwide rights to ILUVIEN® for DME and rights for YUTIQ™ for non-infectious posterior uveitis in the EMEA (not approved for uveitis in EMEA). RETISERT® (fluocinolone acetonide intravitreal implant), for posterior uveitis, is licensed to and sold by Bausch & Lomb, Inc. EyePoint is currently engaged in a collaboration relating to a back of the eye disease. EyePoint will continue to evaluate other potential technology platform agreements.

Slide 6

Prevention of Post Ocular Surgery Inflammation

Slide 7

DEXYCUTM: Well Positioned for Commercial Success 3.1% annual growth rate in the U.S. Most performed surgery in the U.S. Cataract surgeries per year 4.4 Million Surveyed cataract surgeons have expressed strong intent to use DEXYCU™ Major advance in treatment of post cataract surgery inflammation Ambulatory surgical centers that perform more than 500 surgeries per year 1,000 C-Code pass through reimbursement for three years post commercialization Potential pathway to reimbursement within Medicare Part B Two year C-Code extension granted to three ASC drugs in March 2018 Reimbursement in place C-Code Baby boomers; longer life expectancy Improvements to intraocular lenses (IOLs) Experienced surgeons Easy-to-use / non-disruptive to surgeon Offsets significant eyedrop burden

Slide 8

Current Post-Cataract Regimen Requires Polypharmacy and Places Significant Burden on Patients and Physician Offices * Source: Vigamox/Besivance product labeling (not specifically indicated for this use, but are commonly prescribed for use). ** Source: Prolenza/Bromday product labeling (not specifically indicated for this use, but are commonly prescribed for use). Wk 1 Wk 2 Wk 3 Wk 4 21 Drops 3/day* Up to 105+ Drops Over Four Weeks ANTIBIOTIC Prevent infection 14 Drops 1/day** NSAID Reduce Pain/Edema 70+ Drops 3-4/day 3-4/day 2/day 1/day STEROID Control inflammation POOR PATIENT COMPLIANCE WITH DROP REGIMEN COULD LEAD TO POOR OUTCOMES SIGNIFICANT NUMBER OF PATIENT CALL BACKS ARE TIME CONSUMING AND DISRUPTIVE TO OFFICE PATIENTS/CAREGIVERS ARE FRUSTRATED AND CONFUSED WITH REGIMEN IMPACTING SATISFACTION PHYSICIAN PERSPECTIVE

Slide 9

DEXYCUTM Uses Verisome® Technology to Deliver 517mg of Dexamethasone1 Administered as a single dose of 5-mL, intraocularly into the posterior chamber inferiorly behind the iris at the end of ocular surgery Formulated in the fully bioerodible Verisome® technology Wong V. et al.  Pharmacokinetic Study of 10090 in the Anterior Chamber of Rabbits (2013). Note: Refer to the full DEXYCU™ product label at www.eyepointpharma.com

Slide 10

DEXYCUTM (dexamethasone intraocular suspension) 9% Profile Single dose (5mL) administered intraocularly in the posterior chamber at the end of surgery Encapsulated in the fully bioerodible Verisome® technology for extended release of API Wong V. et al.  Pharmacokinetic Study of 10090 in the Anterior Chamber of Rabbits (2013). Note: Refer to the full DEXYCU™ product label at www.eyepointpharma.com API Verisome® Technology DEXYCUTM Kit DEXYCU Placement Detectable up to 22 days after single injection(1)

Slide 11

Phase 3 Study 13-04 Results—Efficacy Placebo (n=80) 517mg (n=156) Percentage of Patients with POD 8 ACC Grade=0 ANTERIOR CHAMBER CELL (ACC) COUNT OF ZERO AT DAY 8 Percentage of Patients with ACC = 0 at Day 8 Note: Subjects who received rescue medicine were treated as failure. Difference vs. Placebo (97.5% CI) 517mg 40% (27%, 54%)

Slide 12

DEXYCUTM Rapidly Reduces Inflammation as Early as Day 1 with Statistical Significance at Day 3 through Day 30 * *P≤0.05 vs placebo Day 8 Primary endpoint Placebo (n=80) DEXYCU™ (n=156) * * *

Slide 13

Phase 3 Study 13-04 Safety Results Safety, n (%) Placebo N=80 517 mcg N=156 Any TEAE in study eye 51 (63.8) 72 (46.2) Any ocular SAE in study eye 0 0 Any non-ocular SAE 4 (5.0) 4 (2.6) Study Eye AEs Occurring in ³5% of At Least One Active Treatment Group Intraocular pressure increased 7 (8.8) 21 (13.5) Corneal edema 8 (10.0) 12 (7.7) Eye pain 7 (8.8) 4 (2.6) Anterior chamber inflammation 10 (12.5) 8 (5.1) Dry eye 0 6 (3.8)

Slide 14

DEXYCU™ (dexamethasone intraocular suspension) 9% Placebo-controlled Phase 3 Clinical Study – IOP Levels Data on file. Phase III Study 13-04. Post hoc analysis. % of patients % of patients % of patients % of patients

Slide 15

Market Research Involving Over 100 Cataract Surgeons Shows High Intent To Use 86% indicated intent to use 72% of patients would be appropriate candidates (see product label for warnings, precautions, and adverse reactions) 87% would recommend to a colleague upon commercial availability Primary market research on file September 2017 Refer to the full DEXYCU™ product label at www.eyepointpharma.com

Slide 16

Cataract Surgery Market Potential US Cataract Surgery Market Over 4 million surgeries in 2017 Steroid drops used post surgery in majority of patients C-Code effective October 2018; valid for 3 years once commercial sale commences Precedent exists for extended C-Code reimbursement period post 3 year horizon

Slide 17

In Preclinical Model Verisome® Technology Dexamethasone (Suspension 9%) is Detectable up to 22 Days with Just One Intraocular Injection Verisome® technology allows for the creation of a sphere containing active drug Droplet formation in aqueous media keeps delivery system intact and provides extended drug release via diffusion DROPLET IMAGES UNDER OPTICAL MICROSCOPY API Source:  Wong V. et al.  Pharmacokinetic Study of 10090 in the Anterior Chamber of Rabbits (2013).  Data on file.

Slide 18

Chronic Non-Infectious Posterior Segment Uveitis

Slide 19

High Unmet Need Opportunities YUTIQTM micro insert for chronic non-infectious posterior segment uveitis approved by FDA on 10/12/18 Two Phase 3 studies with a p value of 0.01 over 12 months Consistent micro dosing over time without drug peaks and valleys Corticosteroids remain the standard of care for posterior segment uveitis Treatment goal is to prevent flares, which can lead to blindness UVEITIS THIRD LEADING CAUSE OF BLINDNESS IN THE US

Slide 20

YUTIQTM: Well Positioned for Commercial Success Estimated to cause up to 10% of legal blindness in the U.S., or ~30,000 new cases of blindness per year (third largest cause of blindness) Patients in the U.S. with severe risk of blindness 55K-120K Corticosteroids remain the standard of care for posterior segment uveitis Treatment goal is to prevent flares, which can lead to blindness YUTIQTM provides consistent micro dosing over time without drug peaks and valleys Two Phase 3 studies completed with p < 0.001 over 12 months Corticosteroids remain the standard of care for posterior segment uveitis Clear Benefit Reimbursement will be obtained initially from an existing, not miscellaneous, J-Code Application will be made for a unique YUTIQTM J-Code Via J-Code Reimbursement

Slide 21

YUTIQ™ Specifically Tailored to Provide Benefit in Severe Disease Uveitis is inflammation of the uveal tract (iris, ciliary body, choroid) or adjacent structures The disease is chronic and patients often experience flares of inflammation and swelling that can lead to severe vision loss and blindness YUTIQ™ provides consistent micro dosing of corticosteroid over time without drug peaks and valleys and has been shown to significantly decrease the recurrence of flares primary goal of therapy

Slide 22

YUTIQ™ 3-year Posterior Segment Uveitis Clinical Program INSERTER TRIAL: EASE OF ADMINISTRATION Study 006 clinical trial: 26 patients Primary end-point: Ease of administration Result: Positive usability Study 001 Phase 3 clinical trial: 129 patients Primary end-point: Prevention of recurrence Result: p < 0.001 First Phase 3 Trial: PREVENTION OF RECURRENCE Study 005 Phase 3 clinical trial: 153 patients Primary end-point: Prevention of recurrence Result: p < 0.001 SECOND PHASE 3 TRIAL: PREVENTION OF RECURRENCE Two Primary Efficacy Studies Ease of Use Study

Slide 23

Primary Efficacy Endpoint of Study 001 & Study 005: Recurrence Rate at 6 and 12 months Study 001 (Recurrence Rate at 6 and 12 Months) Study 005 (Recurrence Rate at 6 and 12 Months) 7.6x 25.9x 1.8x 2.2x p < 0.001 p < 0.001 p < 0.001 p < 0.001 YUTIQTM Patients more likely to be recurrence free YUTIQTM Patients more likely to be recurrence free Sham includes standard of care. * *

Slide 24

Systemic and Local Medications at 12 months ITT population – observed data (STUDY PSV-FAI-001) YUTIQTM patients received substantially less systemic and local rescue medication LESS USE OF RESCUE Sham includes standard of care. *

Slide 25

Reduced Probability of Uveitis Recurrence Through Day 380 After a Single YUTIQ™ FA Insert (STUDY PSV-FAI-001) Note: Sham patients include patients that received rescue therapy ITT Population FAI Hazard Ratio Sham vs. YUTIQ 7.08

Slide 26

YUTIQTM Phase 3 Studies PSV-FAI-001 and PSV-FAI-005 Mean IOP Elevation and Cataract Surgery at 12 Months Percentage mm Hg n = 84 n = 39 Δ = 1.1 mm Hg n = 93 n = 49 Δ = 2.0 mm Hg 14/42 1/21 11/61 3/35 *Sham includes standard of care. * *

Slide 27

YUTIQ™ 6-month vs. 3-year Implant Vitro Release Rate Comparison For Long term in vitro release rate matched with the 3-year insert NOTE: Release rate compared to rate meeting specifications for stability of clinical lot used in Iluvien clinical trials at pre-determined time points (in orange). Potential approval of 6-month duration YUTIQ™ could expand the YUTIQ™ franchise and enable physicians more flexibility Additional regulatory filing planned in 2019

Slide 28

Potential for Two Innovative Ophthalmology Product Launches in 2019 DEXYCUTM YUTIQTM FDA approved 2/09/18 Expected launch 1H 2019 FDA approved 10/12/18 Positioned for Commercial Success Experienced Ophthalmology VP Marketing Several Senior Marketers Senior Ophthalmology Medical Affairs, and MSLs VP Market Access Hired with strong Payor background and track record of success National Sales Director Hired Expected launch 1Q 2019

Slide 29

Commercial Preparations Underway Medical Education Plan Being Executed VP of Medical Affairs in place Multiple KOL Advisory Boards & significant presence at key Congresses Robust Publication plan and key papers on track for publish MSL team near complete Contract Sales Organization Initiated in 2Q 2018 VP of Marketing and Sales in place Dedicated sales team has been interviewed and chosen by EyePoint Management Sales representatives and back office support managed by CSO National Sales Director and DMs managed by EyePoint Payor and Reimbursement Team Build Underway Experienced VP of Market Access in place Reimbursement support services will be provided C-Code (C9034) received for DEXYCUTM J-Code available for YUTIQTM Third party logistics (3PL) in place

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Durasert™: Approved Technology for Ocular Delivery EyePoint is one of few companies that has developed FDA-approved extended-release inserts EyePoint will continue to evaluate potential partnerships that utilize Durasert technology OZURDEX (2009, Allergan) BRVO, CRVO, NIU, DME RETISERT (2005, B&L) Uveitis VITRASERT (1996, B&L) CMV retinitis ILUVIEN (2012, Alimera) DME YUTIQ (2018, EyePoint) Uveitis Selected Major IVT Insert Approvals 4 of 5 Assets Durasert Attributes Proven in FDA-approved products Long duration (can be tailored to last months to years) Broadly applicable to small molecules Strong patent estate (2027 expiry) Source: www.accessdata.fda.gov.

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Financial Highlights Pro forma* Cash of $67.4M $20M Debt Pro forma* 95.2M Shares *Represents cash and shares outstanding as of June 30, 2018, adjusted to reflect warrant exercise in September 2018

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Acquired Icon Bioscience to transform business and accelerate growth Two ophthalmology launches in 1H 2019 Strong leadership team with seasoned executives at the helm Executing on strategy to expand ophthalmology portfolio and utilize existing platform Posterior segment uveitis Postoperative inflammation following cataract surgery EyePoint Highlights Transformational Opportunity in Ophthalmology Obtained $80M+ in capital from new institutional investors