- Second Phase 3 trial of YUTIQ confirms 36-month positive efficacy results 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 TrialPresenter: 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 SurgeryPresenter: 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