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.”
The company is also moving forward in other therapeutic areas. The company’s Open Science research and development model, announced in late 2015, is showing results, Dr. Hashad said.
The concept is based on recognition of a basic shift in innovation. While large pharma companies provide the bulk of the innovation leading to new products and new revenue, the driving source of the innovation comes from smaller biotechnology, specialty pharma companies, and academia. Allergan is refocusing its R&D program to follow innovation to the source.
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“We are becoming more flexible and more open about acquiring new technologies regardless of where the talent and the resources live,” Dr. Hashad explained. “This establishes a stronger relationship with the biotech industry, with healthcare professionals, with regulators and with patient groups.
“This model pushes into and expands an area that has long been a bottleneck in product development, the translational piece. This new model will help us push more products and more innovative technologies into and through this translational area. We are already seeing results in ophthalmology,” he added.
17 potential products
Of the 70-some new products in mid- to late-stage development, about 17 are ophthalmic. Allergan has strong candidates in dry eye and other indications through acquisitions and partnerships.
One of the promising areas is wet age-related macular degeneration (AMD). Wet AMD is a growing problem as the world’s population ages. Swiss biotech company, Molecular Partner, has opened a new therapeutic category–a class of proteins called DARPIns.
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Allergan has acquired global ophthalmologic rights from Molecular Partner, Dr. Hashad reported, including a molecule currently in phase III trials, abicipar pegol. Phase II data suggest the agent is at least as effective as ranibizumab while having a longer duration of action, which could mean fewer injections. Data suggest dosing every 3 months, which could provide an advantage over current anti-VEGF products in clinical use.
The company is also moving forward on a new molecular entity, tavilermide, a small molecule TrkA agonist for dry eye that induces mucin product to treat the dry eye. The product is a collaboration with Mitogen Pharmaceuticals.
Another key product is the first nasal neurostimulation device for dry eye, part of the acquisition of Oculeve. The device induces tear production by stimulating a branch of the trigeminal nerve.
Oculeve has completed four clinical trials in a total of more than 200 patients. Allergan has two pivotal trials in the works and is expecting an FDA submission later in 2016 with a potential commercial launch in 2017.