Liposomal drug delivery system for anti-inflammatory treatment after cataract surgery: a phase I/II clinical trial

Abstract

Liposomes as a drug delivery system may overcome the problems associated with non-compliance to eyedrops and inadequate control of inflammation after cataract surgery. We evaluated the safety and efficacy of a single subconjunctival injection of liposomal prednisolone phosphate (LPP) for the treatment of post-cataract surgery inflammation. This is a phase I/II, openlabel non-comparative interventional trial of patients undergoing cataract surgery. All patients received a single injection of subconjunctival LPP intraoperatively. The primary outcome measure was the proportion of eyes with an anterior chamber cell count of 0 at postoperative month 1. Ocular and non-ocular adverse events, including elevated intraocular pressure, rebound iritis and pseudophakic macular edema were monitored. Five patients were enrolled in this study. The mean age was 66.6 ± 6.2 and 4 (80%) were male. The proportion of patients with AC cell grading of 0 was 0%, 80%, 80%, and 100% at day 1, week 1, month 1, and month 2 after cataract surgery, respectively. Mean laser flare photometry readings were significantly elevated at week 1 after cataract surgery (48.8 ± 18.9, p = 0.03) compared with baseline, decreasing to 25.8 ± 9.2 (p = 0.04) at month 1 and returned to baseline by month 2 (10.9 ± 5.1, p = 1.0). No ocular or non-ocular adverse events were observed. Liposomal prednisolone phosphate, administered as a single subconjunctival injection intraoperatively, can be a safe and effective treatment for post-cataract surgery inflammation. The delivery of steroids with a liposomal drug delivery system could potentially replace eyedrops as anti-inflammatory therapy following cataract surgery.

Ocular Nanomedicine

“…[18a] Interestingly, biocompatible liposomes for different drug delivery have been verified in several clinical trials to combat several ocular diseases, including glaucoma, retinoblastoma, and metastatic malignant uveal melanoma (Table 2). [19] However, it should be noted that potential shortcomings of liposomes, such as the formation of lipid crystal matrix, gelation tendency, in vivo burst release of cargo, and oxidation of liposomal phospholipids, may result in poor shelf-life stability, insufficient drug loading, poor batch-to-batch reproducibility, and high-cost manufacturing of liposomal products, which should be overcome in the future. [20] Lipid nanoparticles, especially SLNs and NLCs, are important alternatives to liposomes, exhibiting an overwhelming advantage over liposomes in terms of cost-effective manufacturing, easy scale-up, and fewer drug-leakage issues.…”