Abstract
Purpose :
To evaluate the safety and efficacy of APP13007 0.05% twice daily (BID) after cataract surgery in a Phase 2 double-masked, placebo-controlled study.
Methods :
Subjects with inflammation on the first post-operative day (POD1) following routine, uncomplicated cataract surgery were randomized (1:1) to receive 1 drop of APP13007 0.05% or placebo BID (morning and evening) in the study eye for 21 days. Subjects were evaluated on PODs 4, 8, 15, 22 and 28.
Results :
Forty-five (45) male/female subjects (mean age 67.7 yrs, 71.1% females and 73.3% white) were randomized to receive APP13007 (APP) (N=22) or placebo (PBO) (N=23). Subject demographics were comparable between the two groups. Seven (7) subjects discontinued the study before POD22: 1 on APP was withdrawn due to an AE (moderate photophobia and eye pain); 3 on PBO were rescued and 3 on PBO were withdrawn for other reasons.
APP was well-tolerated with a safety profile similar to placebo. There were no treatment-emergent SAEs. The most common AEs were ocular disorders commonly reported after cataract surgery (mild to moderate severity; more frequent in the PBO group). There were no AEs related to IOP elevations, no individual IOP was > 21 mmHg and no IOP elevations were > 10 mmHg while on APP13007.
A higher percent of subjects receiving APP achieved ACC count/Grade = 0 at POD8 sustained through POD22 when compared to PBO. Subjects reporting ocular pain at POD1 had rapid resolution on treatment. When compared to PBO, a higher percent of subjects receiving APP had complete resolution of ocular pain at POD4 sustained through POD22. In addition, visual acuity appeared to improve more rapidly in subjects receiving APP compared to PBO.
Number (%) of Subjects with ACC Count/Grade = 0 at a Visit Sustained to POD22:
POD1 (Baseline): APP = 0; PBO = 0
POD4: APP = 0; PBO = 0
POD8: APP = 7 (31.8%) *; PBO = 1 (4.3%)
POD15: APP = 15 (68.2%) *; PBO = 7 (30.4%)
Number (%) of Subjects with Ocular Pain Grade = 0 at a Visit Sustained to POD22:
POD1 (Baseline): APP = 6 (27.3%); PBO = 6 (26.1%)
POD4: APP = 16 (72.7%); PBO = 11 (47.8%)
POD8: APP = 18 (81.8%); PBO = 13 (56.5%)
POD15: APP = 21 (95.5%) *; PBO = 15 (65.2%)
* p < 0.05 (Pearson Chi-Square test)
Conclusions :
These data support the development of APP13007 0.05% BID to treat inflammation and pain following ocular surgery.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.