Taking in the View of 2015 & Beyond
This year’s Ophthalmology Innovation Summits are behind us. We’re piling content onto OIS.NET including the 2015 Year in Review by OIS Founder and Co-Chair Emmett Cunningham, MD.
And, believe it or not, we’re eagerly accepting registration for our next OIS@ASCRS, which will be held on May 5 at the InterContinental New Orleans. (We are now offering a Double Play Deal for those of you who attend both OIS@ASCRS and OIS@AAO – ois.net/oisascrs-registration)
So, as we take a moment to rest at the final peak of 2015, let’s take a long look at what we expect to see in 2016 from our leaders in ophthalmology.
We expect to see the closing of Pfizer’s $160 billion deal to acquire Allergan. We’ve covered that deal extensively in past newsletters and podcasts.
We’ll watch to see if Pfizer’s entrance into ophthalmology forces the hand of other pharmaceutical giants to move into the sector.
But on a more granular level, we’re looking at a flood of clinical information and milestones coming our way in 2016.
We took some time to sift through the company presentations from OIS@AAO, and here are some of the forecasts we’ll be tracking.
Aerie Pharmaceuticals Inc. expects to move forward with two glaucoma drugs, Rhopressa and Roclatan. The company anticipates filing an NDA for Rhopressa in the second half of the year. Meanwhile, it will begin Phase III trials of Roclatan around the same time.
Applied Genetic Technologies Corp. expects to file an IND for its two treatments of achromatopsia – ACHMB-B3 and A3 – in 2016.
Aura Biosciences Inc. hopes to establish clinical proof of concept for its class of intravitreal therapies that target ocular melanoma in the first quarter. The company has received orphan drug designation from the Food and Drug Administration.
Eleven Biotherapeutics Inc. anticipates having a readout from a Phase III trial of isunakinra as a treatment for ocular surface inflammatory diseases in the first quarter of 2016. Meanwhile, the company continues to target diabetic macular edema and uveitis, with projects to file an Investigational New Drug application for EBI-031 in the first half of 2016.
ForSight Vision5 Inc., in addressing non-adherence to eyedrops in glaucoma and in ocular hypertension, has developed Helios, a soft, preservative-free ring infused with bimataprost. The company expects to begin Phase III trials in 2016.
Ocular Therapeutix Inc. promises to be busy in 2016. This month, the company released positive topline efficacy results for the Phase II exploratory trial of Dextenza for the treatment of inflammatory dry eye. The FDA also accepted the NDA for Dextenza as a treatment for post-surgical pain. Next year, the firm hopes to run Phase III trials on Dextenza as a treatment for dry eye and allergic conjunctivitis. If positive, the company will seek to amend the NDA to cover both applications.
Ophthotech Corp., meanwhile, expects to release Phase III topline data by the end of 2016. The company is conducting two fully recruited Phase III trials of Fovista, testing it as an anti-PDGF agent for wet AMD combination therapy.
Second Sight Medical Products Inc. expects to issue an update in 2016 of the software system used to run its approved Argus II Retinal Prosthesis System, which restores vision lost to retinitis pigmentosa, but the larger news may be long term. The company will begin animal trails of its Orion system, which potentially could restore sight in people who lost their vision to other diseases and trauma.
Spark Therapeutics Inc. still plans to file its Biologics Licensing Application with the FDA in 2016 following the positive Phase III trial performance of its lead program, SPK-RPE65, a genetic therapy developed to treat inherited retinal dystrophies. The company reported positive Phase III results earlier this year along with additional data presented at AAO.
Transcend Medical Inc. still awaits word on the PMA it filed in the fall for its CyPass Micro-Stent, a MIGS implant designed to reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma. The company also expects to share data from the COMPASS trial in early 2016. The study has enrolled 505 patients with a two-year follow-up to evaluate both safety and efficacy of the CyPass Micro-Stent implanted in cataract surgery patients to treat glaucoma.
Vision Medicines expects to initiate Phase II/III trials in 2016 of VM100, a monoclonal antibody whose mechanism of action is to clear retinal amyloid (A beta) and its complement. The company hopes to report out its concept data in geographic atrophy in 2017.