Allegro Ophthalmics receives FDA agreement under Special Protocol Assessment for Phase 2b/3 clinical trial of risuteganib for treatment of intermediate dry AMD

According to a news release form the company, the finalization of this assessment indicates that the FDA agrees that critical elements of the overall protocol design are adequate and acceptable for a study intended to support a future marketing application. (Image courtesy of Adobe Stock/Wavebreak Media)

Allegro Ophthalmics LLC announced it has received agreement from the FDA under a Special Protocol Assessment (SPA) for the design of its Phase 2b/3 clinical trial of risuteganib (Luminate) for the treatment of intermediate, non-exudative age-related macular degeneration (dry AMD).

According to a news release form the company, the finalization of this assessment indicates that the FDA agrees that critical elements of the overall protocol design (e.g., entry criteria, dose selection, endpoints, and planned analyses) are adequate and acceptable for a study intended to support a future marketing application.

Vicken Karageozian, MD, president and CEO of Allegro Ophthalmics, said the company was pleased the overall protocol design of its Phase 2b/3 dry AMD clinical trial was finalized by the FDA.

“The agreement by the FDA of the SPA provides a clear regulatory path for our first-in-class drug, risuteganib, for the treatment of intermediate dry AMD for an unmet medical need,” Karageozian said. “This is important because dry AMD leads to irreversible, and in many cases catastrophic, vision loss. A therapy to treat this disease is greatly needed."

According to the company, the Phase 2b/3 study design is based on Allegro's successfully completed U.S. Phase 2a study, in which the primary endpoint was the proportion of subjects with a gain of ≥ 8 letters of vision with two risuteganib injections versus one sham treatment. The Phase 2a trial was a prospective, randomized, double masked, placebo-controlled, multi-center U.S. study that evaluated the safety and efficacy of risuteganib in patients with intermediate dry AMD.

Moreover, the company noted the primary endpoint was met, with 48 percent of patients in the risuteganib arm at week 28 and 7 percent of patients in the sham group at week 12 gaining ≥ 8 letters from baseline (p=0.013). Risuteganib was found to be safe, with no reported drug related serious adverse events (SAEs). Additional findings that support the visual acuity improvement included improvements in retinal sensitivity (microperimetry) and color vision (Lanthony color test).

The Phase 2b/3a study will evaluate efficacy at 52 weeks and safety through 96 weeks. Patients will receive 5 intravitreal injections (IVTs) 12 weeks apart with continued IVT treatment during the follow-up safety portion of the study. The primary endpoint of the study is the improvement in best corrected visual acuity (BCVA) at 52 weeks in the active risuteganib group vs the sham control group.

The company noted this study design also includes threshold OCT screening, such as minimum ellipsoid zone and photoreceptor layer thickness, that strongly predicts BCVA response to treatment, thus helping clinicians predict outcomes and select the patients most likely to benefit from treatment.