Artikel
Phase 3, randomized, paired-eye study comparing the 10 µg intracameral bimatoprost implant with SLT in patients with glaucoma or ocular hypertension
Suche in Medline nach
Autoren
-
Miriam Kolko
- University of Copenhagen, Copenhagen, Dänemark
-
Steven R. Sarkisian
- Oklahoma Eye Surgeons, Oklahoma City, USA
-
Andrew J. Tatham
- University of Edinburgh, Nuffield Health Edinburgh Hospital, Edinburgh, UK
-
K. Sheng Lim
- St Thomas’ Hospital, London, UK
-
Michael Shiu
- Essendon Eye Clinic, Essendon, Australien
-
Harvey Uy
- Peregrine Eye and Laser Institute, Makati City, Philippinen
-
Quoc Ho
- Allergan, an AbbVie company, Irvine, USA
-
Jenny Jiao
- Allergan, an AbbVie company, Irvine, USA
-
Kimmie Kim
- Allergan, an AbbVie company, Irvine, USA
-
Margot L. Goodkin
- Allergan, an AbbVie company, Irvine, USA
-
Marina Bejanian
- Allergan, an AbbVie company, Irvine, USA
-
Michael R. Robinson
- Allergan, an AbbVie company, Irvine, USA
-
James Paauw
- Piedmont Eye Center, Virginia, USA
| Veröffentlicht: | 19. Juni 2024 |
|---|
Gliederung
Text
Purpose: To evaluate the intraocular pressure (IOP)-lowering effect and safety of up to two administrations of the bimatoprost implant vs selective laser trabeculoplasty (SLT) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Methods: Phase 3, randomized, masked, 2-year study in 183 patients with OAG or OHT inadequately managed with topical IOP-lowering medication for reasons other than efficacy (NCT02507687). Patients received one 360° SLT in one eye and up to two administrations of 10 µg bimatoprost implant in the contralateral eye. Initially, all implant-treated eyes received a 2nd implant at week 16 if safety criteria were met. After a protocol amendment, implant-treated eyes were retreated with flexible scheduling only if the IOP was >17 mmHg. The primary efficacy variable was IOP change from baseline with primary timepoints at weeks 4, 12, and 24. IOP measurements after use of rescue treatment were excluded from analysis. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD).
Results: Mean (±SE) IOP at baseline was 25.2±0.22 mmHg in implant-treated eyes and 25.1±0.22 mmHg in SLT-treated eyes. Mean (±SE) IOP reduction from baseline (mmHg) in eyes treated with up to 2 implants vs SLT was 6.8±0.28 vs 6.2±0.28 at week 4, 6.9±0.30 vs 6.4±0.30 at week 12, and 6.9±0.27 vs 6.5 ± 0.28 at week 24. Overall, 67.5% and 50.2% of eyes treated with 1 or 2 implants vs 68.7% and 60.6% treated with SLT remained unrescued at day 360 and 720, respectively. The most common ocular TEAE was increased IOP for both implant- and SLT-treated eyes. Mean (±SE) percentage change from baseline in CECD at month 24 was -3.1±0.43% in SLT-treated eyes vs -6.2±1.13% in implant-treated eyes (-7.9±2.04% with fixed readministration and -5.2±1.35% with flexible administration).
Conclusion: The bimatoprost implant was statistically and clinically noninferior to SLT in IOP change from baseline at weeks 4, 12, and 24 overall and in the subgroup of patients receiving the flexible dosing regimen. Both the implant and SLT demonstrated sustained (2-year) IOP lowering in a substantial proportion of eyes. The safety profile of flexible implant readministration was favorable compared with fixed implant readministration.
References
- 1.
- Kolko M, Sarkisian S, Tatham A, Lim K, Shiu M, Uy H, Ho Q, Jiao J, Kim K, Goodkin M, Bejanian M, Robinson M, Paauw J. Phase 3, randomized, paired-eye study comparing the 10 µg intracameral bimatoprost implant with SLT in patients with glaucoma or ocular hypertension. In: 16th European Glaucoma Society Congress (EGS); 2024 Jun 1-4; Dublin.
