Suprachoroidal RGX-314 well tolerated, improves visual acuity in initial results
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NEW ORLEANS — Initial results from the ALTITUDE study suggest that suprachoroidal RGX-314 is well tolerated in the treatment of diabetic retinopathy, according to a speaker here.
During a sponsored media breakfast at the American Academy of Ophthalmology meeting, Arshad Khanani, MD, presented initial results from the phase 2 ALTITUDE study investigating RGX-314 (Regenxbio), looking at the study’s first cohort of patients receiving 2.5 × 1011 genomic copies per eye of RGX-314 compared with an observational control group.
After 3 months of observation, 33% of patients had a two-step or greater improvement in visual acuity. Four patients (26%) had no change in visual acuity, and visual acuity worsened in three patients (20%).
Patients in cohort 1 improved a mean of 2.6 letters at 3 months, while patients in the observational control group lost a mean of 0.4 letters, Khanani said.
“We look at the safety data, and obviously this is the first trial in diabetic retinopathy,” Khanani said “Not only do you have gene therapy, which is, in my opinion, the future after we figure what’s the best platform, what’s the best delivery, what’s the best vector, and then [you] also [have] a novel delivery approach. Safety is, of course, a priority.”
In the first cohort, consisting of 15 treated patients, there was one serious adverse event, which was determined not to be treatment related. Other treatment-emergent adverse events were also considered to be non-drug-related and mild, including conjunctival hyperemia and conjunctival hemorrhage, Khanani said. There was one case of mild episcleritis, which resolved through the use of topical steroids, and there was no observed intraocular inflammation. Best corrected visual acuity remained stable.
“The longer you treat these patients, you’re going to have more regressions, and the goal is to see if this could be a treatment for our patients with diabetic retinopathy that we see going blind on a daily basis, even though we have a treatment available,” Khanani said.
Regenxbio is currently enrolling patients for the study’s cohort 2 and 3 arms.
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Khanani A. ALTITUDE: RGX-314 gene therapy administered in the suprachoroidal space for participants with diabetic retinopathy (DR) without center-involved diabetic macular edema. Presented at: American Academy of Ophthalmology meeting; Nov. 12-15, 2021; New Orleans.
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