Travoprost Intraocular Implants Reduce Intraocular Pressure in Glaucoma Patients, suggests study

A recent phase 3 clinical trial published in the Ophthalmology journal found 2 models of the travoprost intraocular implant which were the fast-eluting (FE) and slow-eluting (SE) demonstrated significant efficacy in reducing intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. This multicenter, randomized, double-masked, sham-controlled study compared the performance of these implants with the standard treatment, timolol ophthalmic solution (0.5%), over a 3-month period.

The study enrolled patients who had an unmedicated baseline mean diurnal IOP of ≥ 21 mmHg and ≤ 36 mmHg. A total of 590 patients were randomized into 3 groups where 200 patients received the FE implant, 197 received the SE implant, and 193 patients were treated with timolol, applied twice daily. The primary outcome was the mean change in IOP at 8 am and 10 am which was measured at different time points (day 10, week 6, and month 3).

The results showed that both the FE and SE implant groups experienced significant reductions in IOP over the 3-month period. The mean IOP reduction for the FE group ranged from 6.6 to 8.4 mmHg and the SE group showed a reduction of 6.6 to 8.5 mmHg. The timolol group saw a mean IOP reduction ranging from 6.5 to 7.7 mmHg. Also, the implants were noninferior to the timolol group at all 6 time points, with the upper limit of the 95% confidence interval of the difference being less than 1 mmHg.

While the efficacy of the drug was promising, the trial also monitored safety outcomes, including adverse events (AEs). The FE implant group had AEs reported in 21.5% of patients, while the SE implant group reported AEs in 27.2% of patients. The timolol group reported AEs in 10.8% of patients. Most AEs were mild to moderate in severity, with iritis occurring more frequently in the SE group (5.1%) than the FE group (0.5%). Ocular hyperemia and reduced visual acuity were other marked side effects, though these were rare.

One case of serious study eye adverse events, specifically endophthalmitis, was reported. Despite this, the overall safety profile of the implants was considered favorable. The travoprost intraocular implant, whether fast-eluting or slow-eluting, demonstrated robust and consistent pressure-lowering effects over the three-month evaluation period, matching the performance of timolol. Overall, these findings suggest that the travoprost implant could become a viable long-term solution for patients seeking more convenient, single-administration therapies.

Source:

Sarkisian, S. R., Jr., Ang, R. E., Lee, A. M., Berdahl, J. P., Heersink, S. B., Burden, J. H., Doan, L. V., Stephens, K. G., Kothe, A. C., Usner, D. W., Katz, L. J., Navratil, T., Ang, R. E., Heersink, S. B., Vold, S., Atodaria, N., Brubaker, J., Goldberg, D., Lin, C., … Wellish, K. (2024). Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension. In Ophthalmology (Vol. 131, Issue 9, pp. 1021–1032). Elsevier BV. https://doi.org/10.1016/j.ophtha.2024.02.022