Valo Health Suspends Development of OPL-0401, a ROCK Inhibitor for Diabetic Retinopathy, Following Phase 2 Study Results
Valo Health's Decision:
Valo Health has suspended the development of OPL-0401, a non-selective ROCK (Rho kinase) 1 and 2 inhibitor, after it failed to meet its primary and secondary endpoints in a Phase 2 study for diabetic retinopathy (DR)14.
Study Outcomes:
The Phase 2 SPECTRA study did not achieve its primary or secondary objectives in the predefined primary population. However, certain doses tested showed potential evidence of preventing disease progression, and the drug was found to be well-tolerated14.
Unmet Medical Need:
Diabetic retinopathy is a leading cause of blindness in the US, with current treatment options mainly consisting of invasive intravitreal injections and laser treatment targeted to patients with more severe or advanced disease14.
OPL-0401 Background:
OPL-0401 is an oral treatment option with unique physiochemical properties suitable for vascular diseases of the eye, such as diabetic retinopathy. It has been generally safe and well-tolerated across nearly 300 patients and healthy volunteers in 12 Phase 1 and 2 studies combined1.
Future Plans:
Valo Health will seek a partner to further develop the OPL-0401 program, citing the favorable safety profile and evidence of clinical activity with certain doses as reasons for continued evaluation14.
Sources:
1. https://www.valohealth.com/press/valo-health-announces-topline-results-from-phase-2-spectra-study-of-opl-0401-in-patients-with-diabetic-retinopathy
4. https://eyewire.news/news/valo-health-suspends-development-of-dr-drug-candidate-after-phase-2-study-results