Abstract
In this period, several drugs approved for systemic use are being repurposed for posterior segment delivery for treatment of retinal disease. In cornea and external disease, there are several new formulations in late stage development for treatment inflammation and allergy, as well as new molecular entities for the treatment of dry eye. There is also a novel treatment for adenoviral conjunctivitis in development. Work is underway evaluating novel gene therapy treatments, which are at various stages of development. In U.S. government news, implementation of electronic health records (EHR) is challenging, and the U.S. Food and Drug Administration (FDA) is enforcing the law on dietary supplements, as well as dealing with the effect of the government shutdown.
Ophthalmic Pharmaceuticals and Biologics
Aldeyra acquired Helio Vision, a firm developing ADX-2191, intravitreal methotrexate for the treatment of proliferative vitreoretinopathy (January 2019).
Alimera Sciences received product registration for Iluvien® (fluocinolone acetonide intravitreal implant) in Lebanon (February 2019).
Bausch + Lomb acquired U.S. rights to EM-100 from Eton Pharmaceuticals. EM-100 is a preservative-free treatment for the treatment of itching associated with allergic conjunctivitis. The molecule is currently approved, but not disclosed (February 2019).
Clearside's New Drug Application (NDA) for Xipere™ (suprachoroidal injection of triamcinolone actetonide), a treatment for macular edema associated with uveitis was accepted for review by the U.S. FDA (February 2019).
Eyenovia presented results for a phase 3 trial of its microdose phenylephrine/tropicamide for mydraisis (January 2019). In addition, the firm announced an Investigational New Drug application for its microdose atropine (MicroPine) for the prevention of myopia, which was accepted by the U.S. FDA (CHAPERONE study). Finally, the firm is also enrolling patients for a phase 3 study of its microdose latanoprost, MicroProst, for the treatment of open-angle glaucoma and ocular hypertension (February 2019).
Galimedix Therapeutics is in preclinical development of MRZ-99030 (GAL-101) for the treatment of neurodegenerative diseases such as glaucoma and dry age-related macular degeneration (November 2018).
Nicox's NDA for NCX-4251 (fluticasone propionate suspension) for the treatment of blepharitis was accepted for review by the U.S. FDA (January 2019).
Ocular Therapeutix started a clinical study of its OTX-TKI, an intraocular implant with a tyrosine kinase inhibitor, for the treatment of wet age-related macular degeneration (February 2019).
Okogen initiated a clinical trial to evaluate the safety and efficacy of OKG-0301 (ranpirnase) for the treatment of acute adenoviral conjunctivitis (February 2019).
Provectus received orphan drug designation from the U.S. FDA for its small molecule oncolytic immunotherapy PV-10 for the treatment of ocular melanoma (February 2019).
Regeneron presented results in its PANORAMA trial of patients with diabetes who underwent early intervention with Eylea® (aflibercept, February 2019).
ReGenTree will conduct an additional phase 3 trial (ARISE-3) to evaluate RGN-259 for the treatment of dry eye syndrome (February 2019).
Sylentis announced results of its HELIX clinical of its tivanisiran for the treatment of dry eye disease (January 2019).
Gene and Cell Therapy
Gyroscope Therapeutics commenced enrollment for a study of a gene therapy for the treatment of age-related macular degeneration (February 2019).
Janssen Pharmaceutical Companies announced a worldwide collaboration and license agreement with MeiraGTx Holdings to develop, manufacture, and commercialize gene therapy programs for inherited retinal diseases (February 2019).
Ocugen received orphan drug designation from the U.S. FDA for its gene therapy for the treatment of NR2E3 mutation-associated retinal degenerative disease (February 2019).
Regulatory, Government, and Pharmaceutical Industry
CooperVision is sponsoring “The Myopia Management ExpertForum” to help eye care professional with the growing prevalence of pediatric myopia (November 2018).
Genentech is using virtual reality as a training tool for ophthalmologists in a clinical trial of a novel therapeutic (February 2019).
Interoperability of EHR was a requirement of the U.S. 21st Century Cures Act, passed in December 2016. However, little regulation and execution has occurred subsequent to this law (September 2018).
Johnson & Johnson announced that it will include prescription drug prices in its commercials (February 2019).
The U.S. FDA, portions of which were open during the January government shutdown due to user fees, nonetheless suffered and is having challenges recovering (January 2019).
The U.S. FDA posted 12 warning letters and 5 online advisory letters to companies illegally selling >58 products; many are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat, or cure Alzheimer's disease and a number of other serious diseases and health conditions. Concomitantly with this enforcement, FDA is also considering several important new actions and policy priorities to improve the safety of dietary supplements and purported dietary supplements (February 2019).
Footnotes
Author Disclosure Statement
The author consults for numerous ophthalmic pharmaceutical and medical device firms.