Journal of vitreoretinal diseases · 2026
Intravitreal ONL1204 Ophthalmic Solution in Subjects With Macula-Off Rhegmatogenous Retinal Detachment.
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Kleinman David M, Wykoff Charles C, Borkar Durga S, Almeida David R P, Ho Allen C, Miller Joan W, Kocab Andrew J, Puscas Lindsay, Wietholter Stephanie C, Kesteloot Lori L, Zacks David N
Аннотация
PURPOSE: To evaluate the safety and efficacy of ONL1204 as an adjunct to standard-of-care surgical repair in subjects with macula-off rhegmatogenous retinal detachment (RRD).
METHODS: A phase 2, randomized, sham-controlled, single-masked, dose-ranging, multicenter trial was performd in which participants received either a single intravitreal injection of ONL1204 (50 μg or 200 μg) or a sham injection before surgical repair of RRD. The primary endpoint was the mean area under the log contrast sensitivity function at week 24 for participants who did not have primary surgical failure. Key secondary endpoints included mean area under the log contrast sensitivity function at week 12 and mean best-corrected visual acuity (BCVA) at weeks 12 and 24.
RESULTS: One hundred thirty-six enrolled patients were randomized to receive 50 μg ONL1204 (n = 46), 200 μg ONL1204 (n = 45), or sham (n = 45). The primary endpoint was not met; no significant differences were seen in area under the log contrast sensitivity function and BCVA across the groups at weeks 12 or 24. Post-hoc subgroup analyses revealed that higher proportions of pseudophakic patients (88.2% vs 50.0%; P = .013) and patients with >8 days of macular detachment (47.4% vs 10.0%; P = .098) treated with 200 μg ONL1204 achieved 20/50 or better vision at 24 weeks vs sham. ONL1204 demonstrated a favorable safety profile.
CONCLUSIONS: ONL1204 was observed to be safe and well-tolerated. Although the primary endpoint was not met, the potential remains for visual acuity outcomes to be enhanced in patients at higher risk of vision loss from RRD, such as those with an extended duration of macula-off status.
METHODS: A phase 2, randomized, sham-controlled, single-masked, dose-ranging, multicenter trial was performd in which participants received either a single intravitreal injection of ONL1204 (50 μg or 200 μg) or a sham injection before surgical repair of RRD. The primary endpoint was the mean area under the log contrast sensitivity function at week 24 for participants who did not have primary surgical failure. Key secondary endpoints included mean area under the log contrast sensitivity function at week 12 and mean best-corrected visual acuity (BCVA) at weeks 12 and 24.
RESULTS: One hundred thirty-six enrolled patients were randomized to receive 50 μg ONL1204 (n = 46), 200 μg ONL1204 (n = 45), or sham (n = 45). The primary endpoint was not met; no significant differences were seen in area under the log contrast sensitivity function and BCVA across the groups at weeks 12 or 24. Post-hoc subgroup analyses revealed that higher proportions of pseudophakic patients (88.2% vs 50.0%; P = .013) and patients with >8 days of macular detachment (47.4% vs 10.0%; P = .098) treated with 200 μg ONL1204 achieved 20/50 or better vision at 24 weeks vs sham. ONL1204 demonstrated a favorable safety profile.
CONCLUSIONS: ONL1204 was observed to be safe and well-tolerated. Although the primary endpoint was not met, the potential remains for visual acuity outcomes to be enhanced in patients at higher risk of vision loss from RRD, such as those with an extended duration of macula-off status.