Opthea Reports Positive Data From Wet AMD Clinical Trial - Seite 2

The Phase 1 dose escalation enrolled 20 patients (mean age 74.8 years) into three OPT-302 dose level groups (0.3, 1 or 2 mg) in combination with Lucentis^® (0.5 mg) and an OPT-302 monotherapy group (2 mg). Patients received three intravitreal injections of OPT-302 either alone or in combination with Lucentis^® at 4 week intervals, with a week 12 follow-up visit one month after the third dose. For patients who received OPT-302 monotherapy, Lucentis^® rescue therapy was provided at investigator discretion or if patients had a ≥5 letter decrease in vision and no reduction in central subfield thickness (CST) of at least 10% with presence of fluid. All cohorts enrolled 2 naïve patients and 3 patients who had received prior anti-VEGF-A therapy, with the exception of cohort 2 (OPT-302 1.0 mg + Lucentis^®), which enrolled 5 previously treated patients.

The Phase 1 dose escalation study met its primary objective, with OPT-302 demonstrating safety and tolerability both as monotherapy and in combination with standard of care Lucentis^®. Specifically, no dose limiting toxicities and no treatment-related serious adverse events were observed through week 12 of the study. 

Secondary endpoints, which included changes from baseline in best corrected visual acuity and anatomic measures (central subfield thickness (CST)) on spectral domain-optical coherence tomography (SD-OCT) through week 12, demonstrated encouraging clinical activity of OPT-302 in both treatment naïve patients and those who showed a sub-optimal response to prior anti-VEGF-A therapy. 

Overall, a majority of patients (16/19 evaluable at week 12) maintained or gained vision by week 12 compared to baseline and the other 3 patients that all received combination OPT-302 + Lucentis^® therapy did not lose more than 3 letters (range -2 to -3 letters). The mean gain in visual acuity overall from baseline at week 12 in treatment naïve patients who received OPT-302 + Lucentis^® was 16.5 letters (n=4) and 9.5 letters in the 2 mg OPT-302 + Lucentis^® dose cohort (n=2). The mean visual acuity gain from baseline at week 12 in patients who showed a sub-optimal response to prior anti-VEGF-A therapy was 4 letters with combination OPT-302 + Lucentis^® (n=10 evaluable patients; mean number of prior treatment injections = 10.5, range 3 - 55).