Biotech Values

[DewDiligence]

GKOS—Travoprost intraocular implant NDA has 12/22/23 PDUFA date:

https://www.businesswire.com/news/home/20230505005442/en

iDose TR is a micro-invasive intraocular implant designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. iDose TR is designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time. It is designed such that it can be removed and replaced with a new iDose TR, thus potentially offering a long-term dropless alternative to daily eye drop treatment.

iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical IOP-lowering medications.

Emphasis added.

This is a 505b2 NDA—i.e. a new formulation of an existing (now generic) drug. Travaprost (brand name Travatan) was FDA-approved as an eye drop in 2001.

p.s. Mark Foley (RVNC's CEO) has been on GKOS' BoD since 2014 and is currently the lead independent director.