Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity levels 47 (moderately severe NPDR) and 53 (severe NPDR) at Weeks 24 and 48 from baseline.

The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.

The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.

The vision threatening complications in the study eye due to diabetic retinopathy were indicated by the presence of "Vitreous hemorrhage" or the presence of "Tractional retinal detachment" reported on the Ocular Examination - Dilated Ophthalmoscopy CRF (PDR events), and "Neovascularization for the Iris" answered as "Yes" or "Neovascularization for the Angle" answered as "Yes" per the Ocular Examination - Slit Lamp Biomicroscopy CRF (anterior segment neovascularization (ASNV) events).

The CI-DME in the study eye occurred when a treatment emergent adverse event (TEAE) with a mapped preferred term of 'Cystoid macular oedema', 'Diabetic retinal oedema', or 'Macular oedema' occurred in the study eye, in combination with the temporally closest centrally read custom algorithm CST measurement being greater than or equal to 320 microns.

Time to develop any PDR/ASNV was computed as the date of the first development of PDR/ASNV in the study eye minus the date of study treatment administration plus 1 day, divided by 7 days per week.

The occurrence of a CI-DME event in the study eye was identified via examination of centrally read custom algorithm CST data and adverse events.

Percentage of subjects who received anti-VEGF or additional standard of care intervention due to ocular diabetic complications in the study eye are reported. Anti-VEGF use was identified in reported concomitant medication data.

Percentage of subjects who received PRP in the study eye, inclusive of subjects undergoing vitrectomy with endo-laser are reported.

The AUC for change from baseline in BCVA in the study eye were summarized. The AUC through each time point of interest was computed using the trapezoidal rule normalized to months, with a final unit of letters.

Blood samples were collected at the specific visits for the Pharmacokinetic (PK) analysis of EYP-1901 and its main metabolite concentrations.

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. A serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment administration.