FDA approves biodegradable implant for eye conditions
Durysta (bimatoprost implant) received approval from the US Food and Drug Administration (FDA) for the treatment of patients with open-angle glaucoma or ocular hypertension.
The implant is administered directly into the eye where it releases bimatoprost for an extended period of time to provide ‘continuous drug delivery’ before dissolving entirely, the company stated.
The treatment is designed to provide an alternative to topical drops, such as twice-daily timilol, which Durysta proved non-inferiority to in two 20-month clinical trials.
Over the course of the studies, Durysta reduced intraocular pressure by 30% from baseline over a 12-week efficacy period.
In addition, David Nicholson, chief research and development officer at Allergan, stated that the company has an additional five ongoing Phase III trials to increase the product’s indications and further approvals globally.
Allergan is not the only company working on delivering treatments via long-acting biodegradable medication, with Boehringer Ingelheim announcing a partnership with Inflammasome Therapeutics last year with the same aim.
The $160m (€145.5m) deal sees Boehringer combine its portfolio of retinal disease treatments with Inflammasome’s drug delivery technology.
According to Glaucoma Research Foundation, approximately 20% of people are unable to self-administer eye drops therefore companies working to provide an alternative may be able to corner this segment of the market.
