How Was Durysta Evaluated? – Part 5 of 8
How Was Durysta Evaluated? – Part 5 of 8
Durysta is an intracameral implant which is used for lowering intraocular pressure (IOP) in patients with open angle glaucoma (OAG) and Ocular Hypertension (OHT). It is a polymer matrix made from biodegradable material similar to that used for making biodegradable sutures. The matrix contains 10 mcg of bimatoprost, which is released in a sustained manner in the eye and improves the flow of Aqueous Humor, lowering the IOP. The implant generally lasts for 90 days, which gives patients freedom from the need to take eye drops thrice a day, every day.
Studies Conducted on Durysta
FDA approved the use of the Durysta implant for the treatment of glaucoma on the basis of findings from two clinical studies, Artemis and Apollo, conducted on patients with open angle glaucoma.
Phase I/II Apollo Study
Apollo study was a 24 months long controlled paired-eye clinical study conducted on 75 adult patients with OAG or OHT. One eye of the study subjects received the intracameral bimatoprost implant with either 6 mcg, 10 mcg, 15 mcg or 20 mcg of bimatoprost and the other eye received topical bimatoprost 0.03% drops. The results of the study indicated that:
- After 24 months, the drop in IOP was 7.5 mmHg in the eyes that received 6 mcg implant, 7.3 mmHg in the eyes that received 10 and 15 mcg implant; and 8.9 mmHg in the eyes that received 20 mcg implant.
- The implant gradually degraded after implantation. After 12 months, most implants either completely degraded or were estimated to be smaller than the 25% of their original size.
- The bimatoprost implant was equally effective as topical drops in terms of lowering IOP.
- Unlike topical bimatoprost drops, bimatoprost sustained release implants did not cause complications such as conjunctival hyperemia, cystoid macular edema and excessive eyelash growth.
- Although the implant is designed to last for 90 days, the effects last way much longer than expected.
- The efficacy of a second implantation was similar to that of the first.
Phase 3 Artemis Study
Artemis was a 20 month long pooled phase III randomized clinical study that was conducted on 1122 patients with open angle glaucoma or ocular hypertension. The study was focused on comparing the effects of topical timolol 0.5% drops and the Bimatoprost 10 mcg and 15 mcg. In the 20 months long study, it was found that the implant was effective in lowering intraocular pressure by about 30% over a 12-week period, which met the predefined criteria for non-inferiority of the implant against topical timolol 0.5% drops.
Consult Today
Durysta Implant is the newest addition to the range of available treatments for glaucoma and can give relief to patients that have to take topical drops thrice a day, every day. OAG or OHT patients must consult an experienced ophthalmologist to discuss their eligibility for the Durysta implant. If you or a loved one is seeking advice regarding Glaucoma or any other eye condition in and around Texas, look no further. Texas Eye and Cataract has a team of experienced eye doctors with expertise in treating conditions such as glaucoma and cataract. To book an appointment with one of our eye doctors, call 469-505-2020 or email info@teceyecare.com.
At Texas Eye and Cataract, we know how important it is to see life with clear vision. We understand that being your best means seeing your best.