Abstract
The Association of Ocular Pharmacology and Therapeutics (AOPT) is an international organization with the mission of encouraging and advocating research, training, publication, and dissemination of knowledge in basic, clinical, and translational research for eye diseases. Every 2 years a scientific congress is held to facilitate this mission and to encourage continued research and collegiality among young and seasoned investigators. Since 1970, the association has held a biennial scientific meeting alternating between the United States and an international venue. The last face-to-face meeting was held in New Orleans, Louisiana, in March 2019. Because of pandemic-related worldwide travel restrictions, the most recent meeting was held online in March 2021. Each meeting includes 12 scientific sessions presented for 3 days and includes 200 scientists, physicians, vendors, and industry experts from the academic, regulatory, and corporate sectors of ocular pharmacology.
This special issue of JOPT, “Regulations, Generics, and Disruptive Technologies in Ophthalmology: What Every Scientist Needs to Know,” contains proceedings from 2 of the scientific sections of the 2019 meeting of AOPT held in New Orleans. As is surely the case now in 2021, there is heightened awareness in medicine and research about the delivery of novel drugs, procedures, and technologies to diagnose and cure diseases that cause blindness in a manner that provides cost-effective access. The article by Dr Steven Becker of the National Eye Institute (NEI) discusses the set of “Audacious Goals” promulgated by the National Institutes of Health to advance regenerative medicine strategies and increase understanding of the pathobiology of retinal disease. This effort is still ongoing under the aegis of the new director of NEI, Dr. Michael Chiang. The articles by Glickman (photoacoustics), Gelfman (gene therapy), Nasonkin (cell therapy), and Dong (nanoparticles) focus on the journey from bench to bedside for some innovative tools and technologies that are in development for diseases such as age-related macular degeneration. These novel approaches are among the “Disruptive Technologies” that will change and advance eye care going into the future.
In parallel to pharmacological and technological developments, our growing need to bring these medical advances safely and effectively into the mainstream of ocular health care has made it imperative that regulatory professionals equip themselves and the public with tools for extending these novel methods to generations of medicines to come. Dr. Markham Luke of the Food and Drug Administration (FDA) and his team from the Office of Generic Drugs attended the meeting in 2019 and described the new efforts in that division for creating safe generics of ophthalmic drugs. To be approved as a therapeutic equivalent, a generic product must demonstrate that it is both pharmaceutically efficacious and bioequivalent to the brand name drug product, which can involve innovative analytical methods and study designs. With the formulations of solutions, the concept of generic formulations is straight forward. In the case of drugs prepared for ophthalmic use where many formulations include suspensions, ointments, or emulsions—the requirement for bioequivalence is often waived. Judging from the lively discussions after the presentations, we think these special sessions achieved their goal of introducing these topics and controversies to the AOPT community.
To round out this issue, the editorials from Drs. Ruikang Wang, Stephen Jacques, and Igor Nasonkin provide expert points of view on how these emerging new technologies will impact present and future trends of ocular pharmacology and therapeutics.