A twice daily ophthalmic hydrogel of netilmicin/dexamethasone is noninferior to a 4 times a day drop formulation of the same drug for the treatment of post-cataract surgery inflammation, according to findings published in Advances in Therapy.
Patients (N=168, mean age 72.7 years, 62.5% women, 98.2% White) undergoing phacoemulsification with intraocular lens (IOL) implantation for grades 2 or 3 cataract were recruited for this international phase 3, randomized, double-blind, noninferiority study at 3 sites in Italy and 2 in Germany. Patients were randomized to receive single-dose ophthalmic hydrogel administered twice per day (n=85) or single-dose eye drop solution administered 4 times per day (n=83). The primary outcome was inflammation in the anterior chamber at postoperative day 7.
For preventing inflammation, 89.7% of the hydrogel and 95% of the eye drop cohorts were responders. In the univariate analysis, the between-group risk difference was -0.0526 (95% CI, -0.0562 to 0.1613) which was greater than the noninferiority limit of -0.10.
No signs or symptoms of inflammation, specifically, anterior chamber flare, cellularity, lid edema, conjunctival hyperemia, corneal edema, ocular pain, photophobia, or tearing differed significantly between groups up to day 15.
No signs of infection or endophthalmitis were observed.
Among the hydrogel group, 2 patients reported mild discomfort which resolved by day 7. But at day 15, one patient reported distressing moderate discomfort. For the eye drop cohort, 1 patient reported severe discomfort which resolved by day 7. Similarly, at day 15, one patient reported mild discomfort.
Four hydrogel recipients and 6 eye drop recipients reported at least 1 adverse event. One hydrogel recipient had a drug-related adverse event of hypersensitivity. One patient in the hydrogel group had an increase in intraocular pressure at day 1, which resolved by day 7.
The major limitation of this study was the choice to evaluate anterior chamber inflammation using a slit-lamp examination instead of using a laser flare and cell meter approach.
The study authors report that the gel formulation, “allows a reduced administration frequency while maintaining the same efficacy and simultaneously favoring patients’ convenience and comfort, with possible better compliance to treatment and patients’ quality of life.”
Disclosure: One study author declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Mencucci R, Ach T, Liekfeld A, et al. Reduced posology of an ophthalmic hydrogel containing dexamethasone/netilmicin to prevent and treat ocular inflammation after cataract surgery: efficacy and tolerability. Adv Ther. Published online October 7, 2022. doi:10.1007/s12325-022-02295-y