Kala Pharmaceuticals announced publication of two multicenter, randomized, double-masked, vehicle-controlled clinical trials of Inveltys (loteprednol etabonate ophthalmic suspension 1%) for treatment of inflammation and pain following cataract surgery.
Inveltys, which utilizes AMPPLIFY Drug Delivery Technology, is the first and only FDA approved twice-daily (BID) ocular corticosteroid for the treatment of postoperative inflammation and pain following ocular surgery. Published in Clinical Ophthalmology, these two large trials demonstrated that when used BID, Inveltys is an effective choice with a demonstrated safety profile for patients who have undergone cataract surgery.
- In the pooled analysis of the two trials, 386 patients with normal levels of post-operative inflammation used Inveltys BID for 2 weeks after cataract surgery; 325 patients used placebo (vehicle).
- Inveltys helped significantly more patients achieve complete resolution of inflammation, defined as zero anterior chamber cells, at day 8 and day 15 following surgery.
- Significantly more patients treated with Inveltys had no eye pain at day 8 and day 15 following surgery.
- Inveltys treatment was well tolerated, with fewer adverse events than placebo.
o The most common adverse drug reactions were eye pain (1% vs 2.8%, Inveltys vs placebo, respectively) and posterior capsular opacification (1% vs 1.2%, Inveltys vs placebo, respectively). These reactions may have been the consequence of the surgical procedure.
“For patients recovering from cataract surgery, BID Inveltys eliminated pain in a few days and resolved inflammation completely. As surgeons who see patients struggle with using multiple drops per day after surgery – and sometimes skipping drops – the fact that a BID-dosed corticosteroid is an effective option comes as welcome news,” said Preeya Gupta, MD, of Duke University Eye Center, one of the study’s authors.
Corticosteroids are the foundation of therapy for post-ocular surgery care, with the key goal of controlling inflammation and pain caused by surgical trauma to the eye, thus promoting healing. For the drugs to succeed, patients must adhere closely to the steroid regimen.
AMPPLIFY Drug Delivery Technology utilizes mucus-penetrating particles with two proprietary attributes: 1) selectively sized nanoparticles (200-400 nm) to allow for penetration into mucus pores and 2) a mucus-penetrating surface coating to prevent the nanoparticles from adhering to mucus. In a preclinical study, AMPPLIFY delivered 3.75 times more loteprednol etabonate to the target ocular tissue than traditional loteprednol etabonate suspension 0.5%.
The BID regimen of Inveltys is effective and mirrors the regimens of two other drops taken by most patients after cataract surgery (an antibiotic and a non-steroidal anti-inflammatory drug [NSAID]).
“Surgeons have worked continually to build cataract surgery into a remarkably safe, predictable procedure undergone by millions of people every year. We see an important role for Inveltys in that evolution,” Kim Brazzell, PhD, Chief Medical Officer of Kala Pharmaceuticals, said in a company news release. “Ophthalmologists are very familiar with the fact that the more eye drops patients need to use, the less likely they are to comply with the regimen completely. Now data from these clinical trials shows that cataract surgery patients can get the efficacy of Inveltys BID, instead of the four drops a day required for other corticosteroids. That efficacy, continuity and convenience may potentially translate into greater compliance.”
Source: Kim T, Sall K, Holland EJ, Brazzell RK, Coultas S, Gupta PK. Safety and efficacy of twice daily administration of KPI-121 1% for ocular inflammation and pain following cataract surgery. Clinical Ophthalmology. 2019;13: 69-86.