Eyes on New Product Development

• Aerie Pharmaceuticals released long-term safety information on AR-13324 (now known as netarsudil ophthalmic solution), its new chemical entity in Phase 3 trials for the treatment of glaucoma (February 2016).

• Aerpio announced results in its Phase 2a study of systemic AKB-9778 for the treatment of diabetic retinopathy in TIME-2 study (February 2016).

• Encore Vision completed enrollment in its Phase 1/2 trial of topical EV06 ophthalmic solution (lipoic acid choline ester) for the treatment of presbyopia (January 2016).

• Eyegate Pharmaceuticals started enrollment in a confirmatory Phase 3 clinical trial of its EGP-437 combination product in patients with noninfectious anterior uveitis (January 2016).

• Eyevensys was granted Orphan Drug Designation in the European Union for EYS606 for the treatment of noninfectious uveitis. EYS606 is a combination product and method consisting of a plasmid, encoding for a soluble TNFα-receptor, and a high precision electrotransfection-injection system (February 2016).

• Novartis' LFG316, an anticomplement C5, had reports on its use in a Phase 2 geographic atrophy study (February 2016).

• Ocular Therapeutix announced a Phase 3 clinical development strategy for its OTX-TP (sustained release travoprost) drug product candidate for the treatment of glaucoma and ocular hypertension (February 2016).

• Ophthotech announced start of dosing in a Phase 2/3 clinical study of Zimura^® (avacincaptad pegol sodium), an inhibitor of complement factor C5, in patients with geographic atrophy (January 2016).

• Shire resubmitted its NDA for lifitegrast for the treatment of dry eye with a new Phase 3 clinical study, OPUS-3, and FDA has accepted it for review (February 2016).

• Alcon is acquiring Transcend Medical, a firm with a MIGS product in late stage development (February 2016).

• Glaukos is launching its iStent trabecular micro-bypass stent in Canada, and has established a sales organization in Australia (February 2016).

• Allergan and AstraZeneca are working together to develop a new antibiotic to treat infections caused by metallo-β-lactamase-producing Gram-negative pathogens (January 2016).

• Bial-Portela's Phase 1 trial in France of an oral neurological drug (BIA 10-2474) resulted in the death of a subject and serious injury in four additional subjects (January 2016).

• Dr. Alex Zhavoronkov, director of the UK-based Biogerontology Research Foundation, is planning a journal on self-experimentation with putative therapeutic agents. The legality and ethics of this in current standards are a matter of discussion (January 2016).

• F1000Research created a new channel dedicated to publications of nonconfirming and confirming results. ¹

• GeoVax Labs, in collaboration with the University of Georgia, is developing a prophylactic treatment for Zika virus (February 2016).

• The US FDA extrapolated efficacy results from adults to pediatric patients for pharmacotherapy of partial onset seizures, obviating independent clinical efficacy trials (February 2016).

• The US Government Accountability Office found flaws in the FDA's system for postmarketing studies (January 2016).

• The US Justice department is investigating over-the-counter, compounding creams (typically heavily promoted, including to US military and veterans) for fraudulent sales programs (February 2016).

• US Senators Richard Burr (R-NC) and Al Franken (D-MN) are sponsoring the “FDA Device Accountability Act” (SB 1622) to reduce the regulatory burden of medical device development in the US (February 2016).

• Valeant's Interim CEO, Howard Schiller, is lobbying the US Congress to change the law that makes it illegal for pharmaceutical firms to provide rebates to Medicare patients (February 2016).

• Walgreens is installing medication disposal kiosks in more than 500 drugstores across the United States in an effort to combat prescription drug abuse (February 2016).