While the planned merger between Allergan and Pfizer did not surface, Allergan is moving forward with plans to introduce innovative a new drug delivery device and a new surgical device for glaucoma.
“We are starting to see a lot of new technologies and innovations in glaucoma,” said Yehia Hashad, MD, vice president of clinical development, global head of ophthalmology, Allergan. “We see a dramatic shift in the treatment paradigm for glaucoma, moving from a lot of eye drops to new technologies. The first technology we aim to be disruptive with is bimatoprost-sustained release.”
Dr. Hashad described Allergan’s sustained release project during an Industry Spotlight session at the 2016 Glaucoma 360 meeting. The new device is a biodegradable implant that is inserted into the anterior chamber, where it elutes bimatoprost at a steady rate over 4 to 6 months. The company is recruiting patients for its first phase III trial.
“We believe this sustained-release formulation will deliver the right dose directly to the target tissue and eliminate the compliance piece with patients,” Dr. H
Hashad said. “It also has the potential of reducing some of the adverse events that we are seeing quite frequently with eye drops by not exposing non-target tissues to the drug.”
The company is also moving forward on its first minimally invasive glaucoma surgical device with its acquisition of AqueSys. AqueSys’ flagship product, the XEN45 gel stent, has been approved in the European Union and has completed clinical trials in the United States. Allergan is in the final stages of its FDA.
The collage-derived stent is implanted in the anterior chamber and provides for a diffuse outflow of aqueous into the subconjunctival space. The device is 6 mm long and conforms to the ocular tissue, which minimizes problems such as migration, erosion, and corneal endothelial damage. In international trials, the device has shown a 38% reduction of IOP at 24 months.
“Beyond the short-to-medium term, we are looking at other technologies, such as neuroprotection, gene therapy, or stem cells,” Dr. Hashad said. “Glaucoma is a key area for us and we have more to come in the long term after these two key technologies are introduced.”