Additional, more comprehensive, positive data from the 2 large phase 3 ARTEMIS trials of Allergan’s recently approved Durysta implant (Bimatoprost SR) for open-angle glaucoma and ocular hypertension were reported at the 2020 ASCRS Virtual Annual Meeting. Durysta is the first intracameral, biodegradable sustained-release implant for these indications.
The studies focused on such comparisons as higher-IOP cohort vs lower-IOP cohort, phakic vs pseudophakic eyes, prior topical therapies, and prior SLT. As reported by Robert Weinreb, MD, Durysta 10 µg and 15 µg were noninferior to timolol BID in lowering IOP through week 12, both in patients with baseline IOP ≤25 mmHg and in patients with baseline IOP >25 mmHg. In patients with baseline IOP >25 mmHg, Bimatoprost SR lowered IOP on average by 9 mmHg to 10 mmHg, similar to the efficacy of fixed combinations of 2 topical medications.
As reported by Thomas R. Walters, MD, Durysta 10 µg and 15 µg both met the primary endpoint of noninferiority to timolol BID in lowering IOP through week 12. Durysta effectively and comparably lowered IOP and provided sustained IOP lowering in both phakic and pseudophakic eyes. The safety profile of Durysta was acceptable and similar in phakic and pseudophakic eyes.
As reported by E. Randy Craven, MD, ABO, Durysta 10 µg and 15 µg effectively reduced IOP from baseline, and the vast majority of patients were medication-free at 1 year after the third implant, whether they previously used 0, 1, or ≥2 glaucoma medications. Durysta responder rates were high: ≥47% of patients had ≥30% IOP reduction from baseline at weeks 2, 6, and 12.
As reported by Jacob W. Brubaker, MD, Durysta 10 µg and 15 µg effectively lowered IOP in patients with prior SLT. Patients with prior SLT were likely to remain treatment-free for 1 year after the 3rd administration of Durysta. Among patients with prior SLT, the probability of no rescue for 360 days after the 3rd administration was 64% in the Durysta 10 µg arm and 77% in the Durysta 15 µg arm.
“FDA approval marks a breakthrough milestone for the glaucoma community and provides a much-needed option for patients challenged with topical drops or needing alternative options," said David Nicholson, Chief Research and Development Officer, Allergan.