EyePoint Pharmaceuticals Reports Positive Masked Safety Update for Lead Product Candidate EYP-1901 in Ongoing PAVIA and DAVIO 2 Phase 2 Clinical Trials as of September 1, 2023 - Seite 2

In the PAVIA clinical trial, there have been no reported drug-related ocular SAEs and no reported drug-related systemic SAEs. There were two ocular SAEs deemed unrelated to EYP-1901 by investigators:

• Hemorrhagic posterior vitreous detachment (PVD) in a study eye eight weeks after dosing
• Macular edema leading to vision loss in the non-study fellow eye

PAVIA is a 12-month, randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with moderately-severe to severe NPDR. The trial enrolled 77 patients randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg), or to the control group receiving a sham injection. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the trial is improvement of at least two diabetic retinopathy severity scale (DRSS) levels as of week 36 after the EYP-1901 injection. Secondary endpoints include reduction in vision-threatening complications, occurrence of diabetic macular edema and/or proliferative disease, retinal ischemia/nonperfusion and safety. More information about the study is available at clinicaltrials.gov (identifier: NCT05383209).

DAVIO 2 is a randomized, controlled Phase 2 clinical trial of EYP-1901 in patients with previously treated wet AMD. All enrolled patients had been previously treated with standard-of-care anti-VEGF therapy and were randomly assigned to one of two doses of EYP-1901 (approximately 2 mg or 3 mg) or an aflibercept control. EYP-1901 is delivered with a single intravitreal injection in the physician's office, similar to current FDA approved anti-VEGF treatments. The primary efficacy endpoint of the DAVIO 2 trial is change in BCVA compared to the aflibercept control, six-months after the EYP-1901 injection. Secondary efficacy endpoints include change in CST as measured by optical coherence tomography (OCT), number of eyes that remain free of supplemental anti-VEGF injections, number of aflibercept injections in each group, and safety. More information about the trial is available at clinicaltrials.gov (identifier: NCT05381948).