HAWK/HARRIER: Coming in for a Landing
Hossein Nazari Khanamiri, MD Ophthalmology Resident UTMB Ophthalmology and Visual Sciences The late breaking session is reserved for high-profile and potentially industry-moving clinical trial data that becomes available often after the conventional submission deadline. This allows a platform for timely presentation of important data. The session opened by Dr. Jeffrey Heier’s presentation about intravitreal aflibercept as a prophylactic treatment against the conversion to neovascular age related macular degeneration (AMD) in high-risk eyes with non-neovascular AMD. Dr. Heier is from Ophthalmic Consultants of Boston. Interim analysis at month 12 of the clinical trial did not demonstrate a benefit of aflibercept as a prophylactic measure in this particular group of eyes; the rates of conversion to neovascular AMD between the treatment and control groups were not significantly different. The investigators will be examining 24-month follow-up data to see if differences become apparent. Dr. Ian Constable from Lions Eye Institute then presented the three-year follow-up results of rAAV2-sFLT-1 subretinal gene therapy for advanced neovascular AMD. rAAV.sFlt-1 is a rAAV vector carrying the soluble human vascular endothelial growth factor (VEGF) receptor 1. The data showed that gene therapy with rAAV vector was safe and well tolerated and, with further development, could be complimentary to injections of anti-VEGF agents for the long- term treatment of neovascular AMD. A subgroup of gene therapy patients who were doing well at one year showed durability over the course of the following two years. However, all gene therapy patients still required additional injections over three years. The data did not suggest that gene therapy with rAAV2.sFLT-1 could be used as a stand-alone alternative treatment.
Dr. Dante Pieramici from California Retina Consultants gave the final presentation of this short, but very high-yield session. He informed the audience about the initial results from the LADDER trial of the Port Delivery System with ranibizumab. The Port Delivery System with ranibizumab (PDS) is a refillable, indwelling implant that provides diffusion-mediated continuous intravitreal release of ranibizumab. Patients were randomized to different doses of PDS or monthly intravitreal ranibizumab injections. Vision outcomes through month 9 with PDS 100 mg/mL (but not with lower doses) were comparable to monthly intravitreal ranibizumab treatment. PDS implant insertion surgery and refill procedure were overall well tolerated. The investigators concluded that PDS has the potential to reduce high intravitreal treatment burden and improve real world clinical outcomes.