Table 2.

Postoperative Ocular Adverse Events Through Month 48

Intraoperative Adverse Events
None
Postoperative Ocular Adverse Events in 3 Eyes
Case 1:
IOP elevation and BCVA loss >1 line at M32; was prescribed medication but returned with high IOP 1 week later and underwent secondary surgical intervention (trabeculectomy). IOP 18 mmHg preoperatively, 32 mmHg at M32, 12.3 mmHg at M36 (post-trabeculectomy), 11.3 mmHg at M48 BCVA 20/20 preoperatively, 20/40 at M32, 20/40 at M36 (post-trabeculectomy) and at M48 AE reported “definitely unrelated” to study treatment. Status “recovered.”
Case 2:
BCVA loss >1 line at M36 due to cataract progression. BCVA = 20/25 preoperatively, 20/40 at M36 and at M48 AE reported “definitely unrelated” to study treatment. Status “ongoing” (no cataract surgery as of M48).
Case 3:
BCVA loss >1 line at M12 due to cataract progression. BCVA = 20/100 preoperatively, 20/222 at M12 and at M48. AE reported “definitely unrelated” to study treatment. Status “ongoing” (no cataract surgery as of M48).