Opthea, a developer of novel biologic therapies for the treatment of eye diseases, has completed a Type C meeting with the US FDA.
The company said the purpose of the meeting was to obtain regulatory guidance on the clinical development program and proposed Phase 2B clinical trial of OPT-302, Opthea’s novel VEGF-C/D ‘Trap’ therapy for the treatment of wet age-related macular degeneration (wet AMD).
Opthea said it requested the meeting that was held on 8 March with the FDA Division of Transplant and Ophthalmology Products, within the Center for Drug Evaluation and Research.
"The discussions covered the scope and design of the Phase 2B wet AMD clinical trial including patient eligibility criteria, statistical considerations including the potential sample size of the study, rationale for dose levels of OPT-302 and guidance on clinical trial endpoints to evaluate the safety and clinical efficacy of OPT-302 in wet AMD patients," said the company.
According to Dr Megan Baldwin, CEO and Managing Director of Opthea, “We are very pleased with the FDA’s thorough and positive feedback and its continued support to advance the OPT-302 program for back of the eye diseases such as wet AMD. The outcomes from this meeting provide a clear path forward to Opthea as we continue to execute our plan to initiate a larger, randomised and controlled Phase 2B study in wet AMD patients in 2017.”
Opthea’s meeting with the FDA follows the completion of enrolment in the Phase 2A dose expansion cohorts of its ongoing Phase 1/2A clinical trial.
The trial in wet AMD patients who were either treatment naïve or previously treated with anti-VEGF-A therapy, enrolled 20 patients in the Phase 1 dose escalation and 31 patients in the Phase 2A dose expansion.
Patients received OPT- 302 administered by intravitreal (ocular) injection either as a monotherapy (n=13) or in combination with the selective VEGF-A inhibitor, Novartis' Lucentis (n=38), on a monthly basis for 3 months.
Primary analysis data from the Phase 1 dose escalation study demonstrated safety and tolerability of OPT-302 administered as a monotherapy and in combination with Lucentis.
The company said encouraging signs of clinical activity of OPT-302 in the Phase 1 study suggest combined administration of OPT- 302 plus Lucentis may lead to improved visual acuity and anatomical outcomes over Lucentis alone.
It said it anticipates the reporting of outcomes from the ongoing Phase 2A dose expansion cohorts of the clinical trial by the end of March 2017.
Wet AMD is the leading cause of blindness for people over the age of 50 in the US and Europe and is estimated to affect over 1.5 million people worldwide. The prevalence of wet AMD is increasing annually as the population ages and is forecast to rise to 3 million people globally by 2020.