Late breaking clinical trial data to be presented during Retina Subspecialty Day
Late-breaking data from several clinical trials will be presented as part of the Retina Subspecialty Day at the upcoming American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting.
Below are some of the most anticipated presentations of the Late Breaking Developments, Part I session.
Phase 1/2 Trial of AAV5-RPGR Gene Therapy for RPGR-Associated X-Linked Retinitis Pigmentosa (XLRP): 12-month Results
The 12-month results from the ongoing Phase 1/2 clinical trial of the investigational gene therapy AAV-RPGR for the treatment of X-linked retinitis pigmentosa will be discussed. Data previously released, demonstrated AAV-RPGR was generally well tolerated and produced significant improvement in vision after 9-months in a dose escalation phase of the trial.
Avacincaptad Pegol, A Novel C5 Inhibitor, Significantly Reduces the Mean Rate of Geographic Atrophy Growth in the Phase 2/3 GATHER1 Clinical Trial
The prospective, randomized, double-masked, sham-controlled, pivotal phase 2/3 clinical trial assessed the safety and efficacy of avacincaptad pegol, a C5 inhibitor, in 286 patients with geographic atrophy (GA) secondary to AMD. Over a 1-year period, avacincaptad pegol 2 mg and 4 mg was found to significantly reduce GA growth in eyes with AMD, according to study results that were published in September 2020.
AU-011, a Targeted Therapy for Primary Treatment of Choroidal Melanoma (CM) via Intravitreal (IVT) and Suprachoroidal (SC) Administration
Data from the ongoing intravitreal administration Phase 1b/2 clinical study and suprachoroidal administration Phase 2 clinical study evaluating AU-011 in patients with choroidal melanoma, will be discussed. This open-label, multicenter trial is investigating light-activated AU-011, administered via intravitreal injection. Data previously presented showed that the AU-011 was generally well-tolerated in 56 patients treated for safety. The most common treatment-related adverse events were vitreous inflammation, anterior chamber inflammation, and increase in intraocular pressure. Treatment-related serious AEs included vision loss (n = 2).