Abstract
In this review period, a diagnostic ocular product, repurposed from previous systemic use, 1 was approved by the U.S. Food and Drug Administration (FDA). Several novel therapeutics are in early to midstage development for various anterior and posterior segment indications. The U.S. FDA is enhancing enforcement against firms that are marketing unsafe or unapproved drugs.
Ophthalmic Pharmaceuticals and Biologics
D. Western Therapeutics Institute enrolled subjects in their Phase 2B study of topical H-1337, a kinase inhibitor, for the treatment of patients with glaucoma and ocular hypertension (August 2023).
Ocuphire Pharma and Viatris received U.S. FDA approval for its Ryzumvi™ (phentolamine) for the treatment of pharmacologically induced mydriasis produced by adrenergic agonists and parasympatholytic agents (September 2023).
Surface Ophthalmics presented results for its SURF-201, a preservative-free topical formulation of betamethasone sodium phosphate, in a postcataract population (September 2023).
Cell and Gene Therapy
Ocugen is presented data from its Phase 1/2 clinical trial to assess the safety and efficacy of OCU400, a gene therapy product, in patients with inherited retinal diseases mutation(s) in the CEP290 gene (September 2023).
Regulatory, Government, and Pharmaceutical Industry
Eli Lilly filed lawsuits against several compounding pharmacies, spas, and wellness centers around the United States for selling unapproved versions of its Mounjaro® (tirzepatide) diabetes drug (September 2023).
Link Biologics and Théa entered into an agreement to codevelop Link_TSG6, a biological drug based on human TSG-6, for the treatment of Dry Eye Disease and other ophthalmology indications, worldwide excluding Asia (September 2023).
Mati Therapeutics completed a facility dedicated to manufacturing all products formulated in Mati's Evolute sustained ocular drug delivery platform (September 2023).
Otsuka and Shape Therapeutics will collaborate to develop intravitreally delivered adeno-associated viruses for ocular diseases (September 2023).
Science magazine's editor, H. Holden Thorp, PhD, published an editorial comparing the open access policies of his journal with other top science journals, Nature and Cell (September 2023). 2
In response to the Inflation Reduction Act's Drug Price Negotiation Program, companies are beginning to reluctantly enter into price discussions with U.S. Medicare (September 2023).
The U.S. FDA:
○ Took action against firms marketing over-the-counter and consumer products (including cough syrups) containing ethylene glycol and diethylene glycol (September 2023). ○ Issued warning letters to dozens of makers of health care products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found (September 2023). ○ Issued warning letters to 8 companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law (including silver nitrate, September 2023). ○ Issued a warning regarding use of an unapproved product derived from umbilical cord blood used in spine surgeries at a major academic medical center (September 2023). ○ Launched a pilot program to help further accelerate the development of rare disease therapies (September 2023).
3
○ Published draft guidances: Formal Meetings Between the FDA and Sponsors, Labeling for Biosimilar Products, Clinical Pharmacology: Considerations for Peptide Drug Products, Demonstrating Substantial Evidence of Effectiveness with One Adequate Study, Institutional Review Board Review of Individual Patient Expanded Access Submissions for Investigational Products, International Standard for Biological Evaluation of Medical Devices, Assessing Drug Manufacturing Facilities Identified in Pending Applications (September 2023).
Footnotes
Author Disclosure Statement
The author consults for numerous ophthalmic, pharmaceutical, and medical device firms. A complete listing of all of G.D.N.'s consulting affiliations can be found online.