We are a clinical-stage pharmaceutical company developing and commercializing products for treating inflammatory and immune diseases with a focus on the eye and nervous system.
In the fourth quarter of 2020, we acquired Panoptes Ges.m.b.H. (“Panoptes”), transforming our pipeline with the addition of PP-001, a clinical stage Dihydroorotate Dehydrogenase (“DHODH”) inhibitor. PP-001, is a next-generation, non-steroidal, immuno-modulatory and small-molecule inhibitor of DHODH with what we believe to be best-in-class picomolar potency and a validated immune modulating mechanism designed to overcome the off-target side effects and safety issues typically associated with DHODH inhibitors. PP-001 has been developed in two clinical-stage ophthalmic formulations: An intravitreal injection for inflammatory diseases of the eye including posterior uveitis, and a novel nano carrier technology eye drop for ocular surface diseases such as conjunctivitis, dry eye disease and others. Other administration routes are also in development and Investigational New Drug (“IND”) enabling studies are underway for conditions outside the ocular space.
In addition, we are developing the Ocular Bandage Gel (“OBG”), a modified form of the natural polymer hyaluronic acid, designed to protect the ocular surface to permit re-epithelialization of the cornea and improve ocular surface integrity. OBG, with unique properties that help hydrate and protect the ocular surface, is in clinical evaluation for patients undergoing photorefractive keratectomy (“PRK”) surgery for corneal wound repair after refractive surgery and patients with punctate epitheliopathies (“PE”) as a result of dry eye. We are currently developing OBG as a device, but are evaluating the potential to reclassify OBG as a drug. We attended a type-B meeting with the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research
(“CDER”) division during the first quarter of 2021 to discuss OBG’s path forward as a drug and will continue to evaluate the feedback received as we move towards reaching a decision on the reclassification.