Finally satisfied with Ocular's manufacturing setup, FDA approves eye drug/device Dextenza
After two FDA rejections that culminated in a management shake-up and staff cuts, Ocular Therapeutix’s $OCUL eye drug/device Dextenza has finally got the regulatory nod, about a month ahead of the FDA’s expected decision date.
Following ophthalmic surgery, patients are typically prescribed steroids via up to 70 topical eye drops to treat ocular pain. In lieu of this complex regimen, Dextenza offers a full course of post-surgical steroid treatment with a one-time placement of an ophthalmic insert that releases the corticosteroid dexamethasone for up to a month following insertion.
Last year, the Bedford, MA-based company’s shares took a big hit when the FDA slapped Ocular with a second complete response letter, citing manufacturing deficiencies in a pre-NDA inspection the agency undertook months prior. The regulator’s first rejection in 2016 was also related to manufacturing issues.
Ocular, which inked a $300 million-plus partnership with Regeneron $REGN in 2016 to develop a more convenient formulation for the latter’s flagship injectable eye drug Eylea among other anti-VEGF drugs, has a hit-and-miss record with Dextenza in the clinic. The product has yielded positive results in diminishing post-surgical pain, but has came up short in a study for ocular itching associated with allergic conjunctivitis.
The biotech has one product on the market approved to close corneal incisions after cataract surgery, ReSure Sealant, which won the regulatory nod back in 2014. Although Ocular’s hydrogel-based drug delivery platform is designed to provide a competitive advantage over the current treatment paradigm in post-surgical ocular pain and inflammation, adoption and/or access to Dextenza will ultimately depend on pricing and reimbursement.
Last month, EyePoint Pharma $EYPT announced that the CMS had handed Dexycu, its injectable steroid administered after ocular surgery to control inflammation, permanent reimbursement in the form of a J-code, which is typically issued to drugs used in office-based procedures and not to therapies associated with cataract surgery, which are reimbursed within a package price, noted WC Wainwright’s Raghuram Selvaraju.
“There has been doubt among investors on how DEXTENZA can be reimbursed after a C-code expires in three years. With a J-code issued to DEXYCU, which is clearly a product that cannot be dissociated from cataract surgery, we believe it is highly likely that DEXTENZA could also secure a J-code after regulatory approval,” Selvaraju wrote in a note.
On Monday, the company said it planned to submit an application for a J-code ahead of the January 2019 deadline.