Abstract
In this review period, a combination product contact lens drug delivery system was approved in Japan, and another is in early stage clinical development in the United States, while additional ocular drug delivery systems are being evaluated. Results were presented for 2 novel treatments for meibomian gland disease (MGD). Two New Drug Applications (NDAs) were accepted for review by the U.S. Food and Drug Administration (FDA). After years of dispute, one of the world's largest public research universities and one of the largest scientific publishers reached a resolution over a plan for the transition to open access publishing. A hand sanitizer product was recalled because its packaging looked like a water bottle. Issue of product packaging confusion are known in ophthalmology—for example, bottles of superglue looking like eye drops, or product name confusion.1,2 A pharmaceutical firm developing a coronavirus disease 2019 (COVID-19) vaccine made public results at 2 different “cutoff points,” leading to some confusion over efficacy. This issue of data cutoff, especially for Data Safety Monitor Boards (DSMB), is well known to clinical scientists as a challenge in interim analyses. 3
Ophthalmic Pharmaceuticals and Biologics
Johnson & Johnson Vision received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for a combination product of a contact lens with ketotifen for simultaneous correction of vision and relief of allergic conjunctivitis (March 2021).
MediPrint Ophthalmics announced results from its SIGHT-1 (Sustained Innovative Glaucoma and ocular Hypertension Treatment) study of its LLT-BMT1, a bimatoprost-eluting contact lens to treat glaucoma (March 2021).
Azura Ophthalmics presented results from a Phase 2 study of its AZR-MD-001 for the treatment of MGD (March 2021).
Hovione completed its phase 2 clinical trial of topical minocycline patients with dry eye caused by MGD (March 2021).
Oyster Point's NDA for OC-01 nasal spray (varenicline) for the treatment of dry eye disease was accepted for review by the U.S. FDA (March 2021).
Eyenovia's NDA for MydCombi™, a fixed dose combination of tropicamide and phenylephrine, in its Optejet™ microdose system, as a mydriatic agent was accepted for review by the U.S. FDA (March 2021).*
Ocuphire Pharma announced results in the MIRA-2 Phase 3 registration trial investigating phentolamine ophthalmic solution for the reversal of pharmacologically induced mydriasis (March 2021).
Graybug Vision announced data from its 12-month Phase 2b ALTISSIMO trial of its intravitreal GB-102 (sunitinib) drug delivery system for the treatment of wet age-related macular degeneration (wet AMD, March 2021).
Outlook Therapeutics reported results from its NORSE THREE open-label safety study of its ONS-5010/Lytenava (bevacizumab-vikg) to treat retinal diseases (March 2021).
ProQR announced results from a Phase 1/2 study of its QR-421, an intravitreal RNA therapy, in patients with Usher syndrome due to USH2A exon 13 mutations (March 2021).
Gene and Cell Therapy
Lineage cell therapeutics announced results from a phase 1/2a clinical study of its OpRegen (an investigational cell therapy consisting of allogeneic retinal pigment epithelium cells administered to the subretinal space) for the treatment of dry AMD (March 2021).
Medical Devices
Second Sight received U.S. FDA approval for its Argus 2s retinal prosthesis system for use in patients with retinitis pigmentosa (March 2021).
Sight Sciences received 510(k) clearance from the U.S. FDA for its OMNI® Surgical System for canaloplasty followed by trabeculectomy in patients with open-angle glaucoma (March 2021).
Regulatory, Government, and Pharmaceutical Industry
Astra-Zeneca, in announcing results of its COVID-19 vaccine, had negative press regarding differences in efficacy at various cutoff points (March 2021).
Nanoform Finland and Nacuity Pharmaceuticals have signed a Technology Proof of Concept Agreement for Nanoform's nanoparticle technology to enhance ophthalmic drug delivery of Nacuity's NPI-001 and NPI-002 drug candidates (March 2021).
Tarsus Pharmaceuticals and LianBio announced a strategic partnership to develop and commercialize TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex mites in Greater China (March 2021).
PNHC is recalling all lots of Heal the World hand sanitizer packaged in 9.6 ounce because they resemble 9.6-ounce water bottles (March 2021).
The University of California and Elsevier announced a new 4-year agreement that resolves a long-standing dispute over open access and subscription fees (March 2021).
Footnotes
Author Disclosure Statement
The author consults for numerous ophthalmic, pharmaceutical, and medical device firms. A complete listing of all of Dr. Novack's consulting affiliations can be found online.
Funding Information
No funding was received for this article.