Clinical Scorecard: PER-001 Shows Functional and Structural Improvement in Diabetic Retinopathy

At a Glance

Key Highlights

• PER-001 is a novel, long-acting endothelin antagonist delivered via a bio-erodible intravitreal implant lasting 6 months.
• Phase 2a trial showed PER-001 improved low-luminance contrast sensitivity and visual field in diabetic retinopathy patients.
• Structural improvements observed on ultrawidefield fluorescein angiography included reduced ischemia, leakage, and microaneurysms.

Guideline-Based Recommendations

Diagnosis

• Assess diabetic retinopathy severity using diabetic retinopathy severity score (DRSS).
• Evaluate functional deficits with low-luminance contrast sensitivity and visual field testing.
• Use ultrawidefield fluorescein angiography to assess retinal ischemia and microvascular changes.

Management

• Consider PER-001 intravitreal implant as a potential treatment to improve retinal perfusion and function.
• Administer PER-001 implant every 6 months based on current study design.
• Monitor best corrected visual acuity (BCVA) and intraocular pressure (IOP) during treatment.

Monitoring & Follow-up

• Regularly evaluate contrast sensitivity and visual field to detect functional changes.
• Perform imaging studies to monitor structural retinal changes such as ischemia and microaneurysms.
• Monitor for ocular and systemic adverse events; PER-001 was well tolerated with no serious drug-related events reported.

Risks

• No serious ocular or systemic adverse events reported in phase 2a diabetic retinopathy trial.
• No significant changes in intraocular pressure observed with PER-001 implant.

Patient & Prescribing Data

Patients with moderate-to-severe nonproliferative diabetic retinopathy (DRSS 47 to 53).

PER-001 demonstrated safety and tolerability with functional improvements in contrast sensitivity and visual field, and structural retinal improvements after a single injection lasting 6 months.

Clinical Best Practices

• Select patients with moderate-to-severe nonproliferative diabetic retinopathy exhibiting functional deficits for PER-001 treatment.
• Use low-luminance contrast sensitivity and visual field testing as functional endpoints to monitor treatment response.
• Employ ultrawidefield fluorescein angiography to assess structural retinal improvements during follow-up.
• Administer PER-001 via a 25-gauge preloaded injector with a 4 mm implant, similar to dexamethasone implant delivery.
• Plan for biannual injections given the implant’s 6-month drug release and bio-erodible properties.

References

• Clinical Trials at the Summit (CTS) 2025 Presentation
• FDA Regulatory Guidance on Contrast Sensitivity as Endpoint