Study of DEXYCU vs. Prednisolone eye drops shows high patient preference for DEXYCU regimen with statistically better inflammation control, pain, visual acuity outcomes in DEXYCU group
- Second Phase 3 trial of YUTIQconfirms 36-monthpositive efficacyresults from the
- first Phase 3 trial
- Study of DEXYCU vs. Prednisolone eye drops shows high patient preference for DEXYCU regimen with statistically better inflammation control, pain, visual acuity outcomes in DEXYCU group
- Real-world retrospective study of DEXYCU confirms reduction in inflammation seen in
- Phase 3 trial
WATERTOWN, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that positive data for YUTIQ® and DEXYCU® were featured in four presentations at the recent American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting.
Data presented included:
- Statistically significant efficacy results from the second Phase 3 trial of YUTIQ.
- Data from a multicenter retrospective study of real-world usage of DEXYCU which demonstrated significant inflammatory reduction post-cataract surgery.
- New data from an investigator-initiated open-label study comparing a drug treatment regimen of DEXYCU with Prolensa to a full post-operative eye drop treatment regimen which showed superior effects on inflammation, pain, visual acuity and patient preference in favor of the DEXYCU arm. Importantly, patient out of pocket costs were 3.5 higher in the full post-operative eye drops treatment regimen.
“The positive and durable results of both YUTIQ and DEXYCU presented at AAO continue to provide strong support to their product profiles and long-term advantages compared to standard of care treatments,” said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. “Our dedicated YUTIQ salesforce and combined DEXYCU sales team with ImprimisRx are actively engaging treating physicians across the U.S. in order to expand the reach of our products for patients in need.”
Summaries of the AAO presentations are as follows:
Paper Presentation
Title: FAi Insert Treatment for Noninfectious Posterior Uveitis: Three-Year Results of a Confirmatory Trial
Presenter: Glenn J. Jaffe, M.D., Robert Machemer M. D. Distinguished Professor of Ophthalmology, Duke University School of Medicine
Data presented at AAO continues to show consistent efficacy and durability of YUTIQ in the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
Results from the second double-masked, randomized Phase 3 trial of YUTIQ were presented from 153 patients with chronic non-infectious uveitis affecting the posterior segment of the eye, with 101 eyes treated with YUTIQ and 52 eyes receiving sham injections. At 36 months, the recurrence rate in YUTIQ-treated eyes was significantly lower than in sham-treated eyes (46.5% vs. 75.0%, respectively; p=0.001). Visual acuity gains or losses of 3 lines or more were both similar between treatment groups. Considerably fewer YUTIQ-treated eyes (8.9%) needed adjunctive intraocular/periocular injections for uveitic inflammation compared to sham-treated eyes (51.9%). 31.7% of YUTIQ-treated patients were given adjunctive systemic steroid or immunosuppressant compared to 32.7% of sham-treated eyes. Macular edema was resolved in 75.8% of YUTIQ treated eyes and 53.8% of sham treated eyes that had edema recorded at baseline. Mean intraocular pressure (IOP) at 36 months was 14.8 mmHg and 13.4 mmHg in the YUTIQ treated eyes and sham treated eyes, respectively. Intraocular pressure-lowering drops were used in 74.3% of YUTIQ-treated eyes and 73.1% of sham-treated eyes.
Poster Presentations
Title: The D3 Study: Drug Delivery vs. Drops—A Prospective Clinical Study Evaluating Dexycu vs. Prednisolone Acetate 1% in Controlling Postoperative Pain and Inflammation in Patients Undergoing Sequential Cataract Surgery
Presenter: John A. Hovanesian, M.D., Specialist in Cataract, Refractive, Cornea and Pterygium Surgery, Harvard Eye Associates
Data from an investigator-initiated study showed patients significantly preferred a regimen of drug delivery of DEXYCU and Prolensa, a commonly used non-steroidal anti-inflammatory, compared to a full post-operative eye drop regimen. Pain was significantly reduced in the DEXYCU and Prolensa treatment group compared to a full post-operative eye drop treatment regimen. Ocular inflammation scores were significantly higher for the full post-operative eye drop treatment regimen compared to the DEXYCU and Prolensa regimen. The proportion of patients with uncorrected vision of 20/20 was significantly higher at all time points in patients in the DEXYCU and Prolensa regimen compared to the full post-operative eye drop treatment regimen. Data also showed out of pocket costs were 3.5 times higher for the full post-operative eye drop treatment regimen compared to DEXYCU and Prolensa regimen.
Results presented from the post-approval, open-label, randomized, prospective, contralateral eye study consisted of 30 patients (60 eyes) undergoing routine cataract surgery. Patients were randomized to receive DEXYCU intracameral, Moxifloxacin Intracameral, Prolensa or control (Prednisolone drops, Moxifloxacin drops and Prolensa) in the first eye and the alternative regimen in the second eye. The regimen with DEXYCU demonstrated a highly significant (96%; P<0.0000001) preference for this treatment compared to the full post-operative eye drop treatment regimen. No significant difference was noted in intraocular pressure (IOP) at any timepoint.
Title: Dexamethasone Intraocular Suspension 9% After Cataract Surgery: Data from a Retrospective Study
Presenter: Robert J. Weinstock, M.D., Director of Cataract and Refractive Surgery, The Eye Institute of West Florida and the Weinstock Laser Eye Center
Results from the real-world multicenter retrospective study demonstrated the anti-inflammatory efficacy and tolerability of DEXYCU that mirror the results seen in the controlled Phase 3 clinical trials.
Results were presented from 641 eyes of 527 patients treated with DEXYCU. The proportion of eyes with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 40.0%, 65.1%, 85.0% and 89.7% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flare (flare score=0), another measurement of inflammation, was 78.5%, 93.3%, 97.8% and 97.2% at postoperative day 1, 8, 14 and 30, respectively. Targeted best corrected visual acuity was achieved in 97% of eyes. Mean intraocular pressure at postoperative day 1 was 18.6 mmHg, with levels decreasing through to postoperative day 30. Each time point of data in the real-world study reflects patient chart data and frequency of measurement by participating physicians.
Title: Outcomes with Dexamethasone Intraocular Suspension 9% and Concomitant Postoperative Anti-inflammatory Medications
Presenter: Cynthia Matossian, M.D., Founder and Chief Executive Officer, Matossian Eye Associates
Real-world data of DEXYCU showed strong anti-inflammatory efficacy with and without additional topical anti-inflammatory treatment. These results also showed early and sustained anterior chamber cell and flare clearing following DEXYCU treatment.
Results from the multicenter retrospective study were presented from 641 eyes of 527 patients treated with DEXYCU. The proportion of eyes with complete anterior chamber cell clearing (cell score=0) treated with DEXYCU and a topical nonsteroidal anti-inflammatory drug (but no topical steroid) was 58.7%, 67.9%, 84.3% and 92.6% at postoperative day 1, 8, 14 and 30, respectively. This compares to anterior chamber cell clearing in eyes treated with DEXYCU only of 23.9%, 69.0%, 93.8%, and 94.1% at postoperative day 1, 8, 14 and 30, respectively. The proportion of eyes with no anterior chamber flare (flare score=0) treated with DEXYCU and a nonsteroidal anti-inflammatory drug was 78.9%, 93.8, 98.5% and 99.3% at postoperative day 1, 8, 14 and 30, respectively. This compares to an anterior chamber flare score in eyes treated with DEXYCU only of 78.8%, 98.4%, 100.0% and 98.4% at postoperative day 1, 8, 14 and 30, respectively. Data at each timepoint in this real-world study reflects patient chart data and frequency of measurement by participating physicians.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (www.eyepointpharma.com) is a pharmaceutical 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. The Company currently has two commercial products: DEXYCU®, the first approved intraocular product for the treatment of postoperative inflammation, and YUTIQ®, a three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company’s pipeline leverages its proprietary bioerodible Durasert® technology for extended intraocular drug delivery including EYP-1901, a potential six-month sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts with offices in Basking Ridge, New Jersey. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
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 expectations regarding the extent to which our business could be adversely impacted by the effects of the COVID-19 coronavirus pandemic, as well as the timing and clinical development of our product candidates, including EYP-1901; and the potential for EYP-1901 as a vital, novel six-month treatment for wet age-related macular degeneration. 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 extent to which COVID-19 impacts our business; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; 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; potential off-label sales of ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye; consequences of fluocinolone acetonide side effects for YUTIQ; consequences of dexamethasone side effects for DEXYCU; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema, or DME; 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 commercialize ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye in the territories in which Alimera is licensed to do so; our ability to market and sell products; the success of current and future license agreements, including our agreement with Equinox Science; termination or breach of current license agreements, including our agreement with Equinox Science; 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; volatility of 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.
Contacts
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
eyepoint@argotpartners.com
Media:
Thomas Gibson
201-476-0322
tom@tomgibsoncommunications.com
