In this Phase 3 clinical study of 528 subjects with open-angle glaucoma or ocular hypertension, Bimatoprost SR reduced IOP by approximately 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, timolol. Results of this second Phase 3 study with an identical design as the first study, showed that the magnitude of IOP-lowering efficacy with Bimatoprost SR is similar to that observed with topical prostaglandin analogues.
"The data results of intracameral Bimatoprost SR were consistently demonstrated in two pivotal trials, highlighting the sustained, predictable and potentially sight-saving benefits of this exciting new approach in treating patients with glaucoma," said
The study also showed the potential for the vast majority of patients to remain treatment free for at least 1 year after the last implant was inserted. Overall, Bimatoprost SR was well tolerated in the majority of patients. The 20-month masked study is ongoing, and additional data will become available as patients complete the study.
"Glaucoma is the second leading cause of blindness in the world, making it essential to develop innovative new treatments and technologies that effectively address the underlying cause of the disease," said
"Bimatoprost SR has the potential to be the first sustained-release option of a drop-free therapy for patients who are suffering from glaucoma. Proper use of eye drops continues to be a concern for eye care professionals," said
About the Bimatoprost SR Study Design
This multicenter, randomized, masked, parallel-group study in patients with open-angle glaucoma or ocular hypertension compares the efficacy and safety of 2 dose strengths of Bimatoprost SR to timolol eye drops used twice daily for up to 20 months. Patients were randomized to receive 3 administration cycles (Day 1, Week 16 and Week 32) of Bimatoprost SR or twice-daily timolol eye drops in the study eyes. Vehicle eye drops or sham administrations (Day 1, Week 16 and Week 32) were used in the study eyes for masking purposes. The topline results are reported at the prespecified primary analysis time, 12 weeks after the last patient received the first implant.
About Glaucoma and Long-Term Medication Compliance
Glaucoma is one of the primary causes of irreversible vision loss and blindness. In 2018, nearly 130 million people were living with glaucoma globally. This number is expected to rise to an estimated 148 million by 2023. This progressive disease is characterized by elevated IOP. Uncontrolled, elevated IOP causes damage to the optic nerve and loss of vision. Reduction of elevated IOP is the only effective way to stop the progression and vision loss associated with glaucoma.
Current treatments to lower IOP include topical medications (eye drops), laser trabeculoplasty, minimally invasive glaucoma surgery and incisional surgery. Eye drop medications are the standard first-line treatment for glaucoma, but low patient adherence to these medications is common – up to 80 percent of patients are not using topical medications as prescribed. Patients often find it difficult to adhere to their eye drop regimen every day, year after year, because they forget to take doses, cannot afford medications, do not understand their disease, or have trouble instilling eye drops or sticking to the schedule. Poor adherence to topical medications relates directly to disease progression and vision loss. To remove long-term eye drop compliance as a factor in preserving vision, ophthalmologists rely on laser trabeculoplasty, MIGS and more invasive incisional surgeries and await the development of sustained-release medication.
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