Phase III data with Lumigan shows potential in glaucoma or ocular hypertension.- Allergan.

Allergan announced the release of new topline clinical trial data on Lumigan (bimatoprost SR), the first-in-class sustained-release, biodegradable implant for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Bimatoprost SR is designed to lower IOP for at least 4 months, achieving clinical goals while freeing patients from daily eye drop regimens.

In this first Phase III clinical study of 594 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. This initial data showed the potential for the majority of patients to remain treatment free for one year after the last implant was inserted. The magnitude of IOP lowering efficacy with Bimatoprost SR observed in this study is similar to that observed with daily topical prostaglandin analogues. Bimatoprost SR was also well tolerated in the majority of patients. Additional safety data from this study and results from a second Phase III study with an identical design will be reported in the first half of 2019. An NDA filing to the FDA is expected in the second half of 2019.

Comment:Current treatments to lower IOP include topical medications (eye drops), laser trabeculoplasty, minimally invasive glaucoma surgery (MIGS), 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 trabeculectomy, MIGS & more invasive incisional surgeries and await the development of sustained-release medication.