Nancy Lurker is the president, CEO and board director of EyePoint Pharmaceuticals, a Watertown, Mass.-based company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders. EyePoint’s pipeline includes EYP-1901, an investigational sustained delivery anti-VEGF treatment using a bioerodible formulation of Durasert. The company has two commercial products: YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU (dexamethasone intraocular suspension) 9% for postoperative inflammation. Ms. Lurker has 30 years of experience in the pharmaceutical industry, with previous positions at companies including Bristol-Myers Squibb, Pharmacia and Novartis.

Ophthalmology Management: EyePoint is developing EYP-1901 for wet AMD, non-proliferative diabetic retinopathy (NPDR) and diabetic macular edema (DME). How does it work, and what is the significance of this treatment?

Nancy Lurker: EYP-1901 is a sustained delivery intravitreal anti-VEGF treatment containing vorolanib in a bioerodible formulation of our proprietary and proven Durasert technology. Vorolanib is a tyrosine kinase inhibitor that has shown preliminary but consistent clinical efficacy in Phase 1 and Phase 2 trials in wet AMD when delivered orally. It binds receptors of all VEGF growth factors with strong affinity to VEGF receptor 2 — a receptor associated with blood vessel leakage that is the clinical hallmark of wet AMD. EYP-1901 is designed to provide steady inhibition of VEGF receptor activation and could potentially prevent neovascularization and loss of vision.

The Durasert drug delivery platform is a miniaturized, in-office injectable, sustained-delivery technology and offers a stable release of drug in the eye over months or years. Durasert has been safely administered to over 80,000 patients’ eyes across four FDA-approved products, including EyePoint’s YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. Those products used the non-erodible form of Durasert. EYP-1901 uses a novel bioerodible form of Durasert. Further, neither form of Durasert contains PLGA (poly-D,L-sustained lactide-co-glycolide), which can be inflammatory.

OM: Can you discuss the results of the DAVIO Phase 1 clinical trial of EYP-1901 and what’s next?

NL: The final 12-month data from the DAVIO Phase 1 clinical trial of EYP-1901 showed no reports of ocular serious adverse events and no ocular or systemic dose limiting toxicities with stable visual acuity and stable retinal thickness by optical coherence tomography. In addition, 53% of eyes were anti-VEGF supplemental injection-free up to 6 months following a single dose of EYP-1901, which is its targeted dosing frequency, and had a 79% treatment burden reduction compared to the 12-month pre-study period. The first patient has been dosed in the Phase 2 DAVIO 2 clinical trial of EYP-1901 for wet AMD, and we plan on dosing our first patient in a Phase 2 clinical trial for NPDR in Q3 2022. A Phase 2 trial is also planned in DME in 2023.

OM: What other products/developments are in the pipeline at EyePoint for the US market?

NL: We are actively evaluating additional molecules for use in our Durasert technology to address serious eye disease. We hope to update these developments over the coming months.

OM: What unmet needs do you feel are faced by ophthalmologists and their patients, and how can EyePoint help with them?

NL: The biggest unmet need is sustained drug delivery, and our goal is to be the leader in ocular drug delivery. There is a real problem in this category because for most patients, particularly in the retinal space, the available treatment option is a monthly or bimonthly eye injection. That’s very different than just taking an oral pill and going from twice a day to once a day. To have to go to a doctor’s office every month or every other month for the rest of your life and get your eye injected is extremely burdensome, especially since most of these patients are elderly. OM