Treatment Effective for Resolving Ocular Inflammation, Pain Following Cataract Surgery

According to a poster presented at the Annual Meeting of the American Academy of Ophthalmology, ocular inflammation and pain in patients following cataract surgery was effectively treated with KPI-121 1%. 

KPI-121 1% is a topical twice-a-day product candidate for patients with inflammation and pain following cataract surgery, the most common type of ocular surgery in the United States. It was originally approved in August 2018 by the FDA. Beginning in early 2019, it will be marketed as Inveltys. 

To better understand the safety and efficacy of this treatment, a research team led by John Sheppard, MD, of Virginia Eye Consultants and Eastern Virginia Medical School (Norfolk, Virginia), and colleagues, conducted two multicenter, prospective, masked, randomized Phase 3 cataract surgery trials. Within the two trials, 386 participants with ≥ Grade 2 anterior chamber cells after surgery were treated with KPI-121 dosed twice daily and 325 patients with vehicle for 2 weeks. The main outcomes the researchers measured included complete resolution of ocular inflammation and complete resolution of ocular pain at days 8 and 15, and safety/tolerability.

Based on the findings, the researchers observed statistical significance that favored KPI-121 1% for both primary endpoints in each trial (P = .0024, P = .0105 for inflammation resolution; P = .0019, P < .0001 for pain resolution).  According to pooled data, a significantly higher number of those treated with KPI-121 1% had resolution of inflammation at days 8 and 15 (P ≤ 0.0001) and resolution of pain at days 4, 8, and 15 (P < 0.0001). The researchers noted that the most common adverse events observed were eye pain and posterior capsule opacification (1.0% for KPI-121 vs 1.2 to 2.8% for vehicle).

“KPI-121 1%... was effective in resolving ocular inflammation and pain in patients following cataract surgery,” Dr Sheppard and colleagues concluded.”

—Julie Gould