Allegro Ophthalmics has its sights set on a Phase II/III trial in dry age-related macular degeneration (AMD) after receiving a regulatory stamp of approval.

Allegro announced that the US Food and Drug Administration (FDA) agreed that the company’s proposed Phase II/III protocol in dry AMD was acceptable for a study supporting eventual registration. The San Juan Capistrano, California-based biotech will test its lead candidate risuteganib, a synthetic peptide designed to reduce mitochondrial dysfunction.

With risuteganib, Allegro is eyeing a dry DMD market with limited treatment options available.

Dry AMD is among the leading causes of vision loss for older adults, but there is only one FDA-treatment available. Apellis Pharmaceuticals’s Syfovre (pegcetacoplan) earned FDA approval in February for geographic atrophy, an advanced form of dry AMD.

Meanwhile, risuteganib targets intermediate dry DMD, an earlier stage of dry DMD with a high unmet need. Intermediate dry AMD is characterized by mild symptoms that can eventually progress to more severe forms of visual disability.

Allegro has not yet disclosed a timeframe for initiating the planned Phase II/III study.

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Allegro’s Phase II/III trial plans

The planned Phase II/III trial will evaluate efficacy at 52 weeks and safety through 96 weeks. As a primary endpoint, the sham-controlled study will measure improvement in best corrected visual acuity (BCVA), which measures the ability to read increasingly smaller letters and numbers from a distance.

In a previous Phase IIa trial (NCT03626636), risuteganib met its primary endpoint of change in BCVA, and the company reported no serious adverse events.

AMD can cause blurred central vision when aging leads to damage of the macula. Despite dry AMD accounting for the majority of AMD cases, there are fewer trials targeting dry AMD than wet AMD.