Novel Triamcinolone Acetonide-Loaded Liposomes Topical Formulation for the Treatment of Cystoid Macular Edema After Cataract Surgery: A Pilot Study

Abstract

Purpose: To report tolerability, safety, and efficacy of a topical triamcinolone acetonide-loaded liposomes formulation (TA-LF) in targeting the macular area in patients with refractory pseudophakic cystoid macular edema (PCME). Methods: For tolerability, safety and efficacy evaluation, 12 eyes of 12 patients with refractory PCME were exposed to one drop of TA-LF (TA at 0.2%) every 2 h for 90 days or until best-corrected visual acuity (BCVA) was achieved. Intraocular pressure (IOP), slit lamp examination, and central foveal thickness (CFT) were analyzed at every visit. Results: Patients with refractory PCME under TA-LF therapy showed a significant improvement in BVCA and CFT without significant IOP modification ( P = 0.94). On average CFT decreased to 206.75 ± 135.72 μm and BCVA improved to 20.08 ± 10.35 letters ( P < 0.0005). BCVA was achieved at 10.58 ± 6.70 weeks (range 2–18). TA-LF was well tolerated in all cases. Neither ocular surface abnormalities nor adverse events were recorded. Conclusion: TA-LF was well tolerated and improved BCVA and CFT on patients with refractory PCME.

Novel Triamcinolone Acetonide-Loaded Liposomal Topical Formulation Improves Contrast Sensitivity Outcome After Femtosecond Laser-Assisted Cataract Surgery

“…26 Finally, multiple efforts have been made to generate a topical formulation for the delivery of TA into the posterior segment of the eye using different delivery strategies such as those that include liposomes and lipid nanoparticles 26,28,72,73 ; however, only TA-LF has been proved in clinical assays, where its efficiency and safety profiles have satisfactorily been demonstrated. 27 Once again, in this study, we observed that TA-LF is well tolerated and holds an acceptable safety profile, with no ocular AEs.…”

“…In synthesis, TA-LF has proved to deliver TA into the vitreous cavity and the retina, evading ocular barriers. 26 Moreover, it has been demonstrated that this formulation is efficient in the management of refractory PCME, 27 and, as our results have already shown, it is also useful in the prophylactic treatment of PCME without inducing a rise in IOP or the appearance of side effects.…”

“…TA-LF topical therapy was related to an improvement in BCVA and a reduction in CFT in patients with refractory PCME, but without inducing an increase in IOP. 27 In fact, an important observation made in our trial was that IOP rises were not documented in any of the study groups. Conversely, IOP significantly decreased after cataract surgery.…”

“…Recently, an innovative topical triamcinolone acetonide-loaded liposomal formulation (TA-LF) was used to efficiently deliver triamcinolone (TA) into the vitreous and the retina of rabbits 26 and its therapeutic efficiency was verified in patients with refractory PCME. 27 We performed this clinical assay to evaluate visual outcomes, particularly those related to CS, macular modifications, and the incidence of CSME, using TA-LF as an anti-inflammatory therapy in patients that underwent FLACS.…”

Clinical Course of Pseudophakic Cystoid Macular Edema Treated with Nepafenac

“…In refractory PCME cases, the use of bevacizumab reduced macular thickness and improved BCVA in retrospective and prospective non-comparative studies [36]. In addition, in PCME topical triamcinolone-liposomes [37], interferon alpha 2b [38], interferon alpha 2a taken systemically [39], and the use of intravitreal infliximab [40] showed promising anatomical and functional responses to the treatment. To avoid overtreatment, based on the results presented here, we do not recommend the routine use of intravitreal or periocular injective treatments, nor systemic drug administration.…”