FDA grants clearance for Endogena’s age-related macular degeneration treatment

The company will launch a clinical investigation of EA-2351 for geographic atrophy

The US Food and Drug Administration (FDA) has granted clearance for Endogena Therapeutics’ investigational new drug application to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD).

The FDA clearance will enable Endogena to progress with the clinical investigation of EA-2351.

Estimated to affect 9% of the population older than 45 years, AMD is an eye disease that can blur the central vision and is a leading cause of irreversible vision loss.

As part of late-stage AMD, GA is a chronic-progressive degeneration of the macula, part of the retina at the back of the eye, which can lead to irreversible loss of vision over time.

Embarking on their second programme to progress into clinical trials, Endogena’s EA-2351 will centre on retinal pigment epithelial (RPE) cells, which keep the retina alive and enable and restore photoreceptor cells to detect light.

EA-2351 builds on the company’s ongoing EA-2532 programme initiated in July this year, which focuses on activating one set of cells in relation to the condition of retinitis pigmentosa (RP).

EA-2532 is a first-in-class small molecule that selectively activates endogenous retinal stem and progenitor cells to preserve and restore visual function.

Both EA-2351 and EA-2532 will target specific cell populations through different pathways.

Matthias Steger, chief executive officer of Endogena, said: “Many of us will know someone touched by this terrible disease, which makes our work even more pertinent.
“We look forward to continuing to develop yet another potential therapy for a condition with a high unmet medical need, thereby providing hope for patients affected by AMD.”

Most recently, in May this year, Endogena completed enrolment in its phase 1/2a trial to examine the safety, tolerability and preliminary effects of intravitreal EA-2353 for RP.

Since launching, the trial has been conducted across five US sites and has enrolled 14 patients with RP due to any pathologic genetic mutation.