Abstract
In this period, several gene therapy firms are progressing with clinical studies for the treatment of retinal diseases, a firm with a combination product of light-activated viral nanoparticles is proceeding to further clinical trials in treating ocular melanoma, and a device firm is evaluating photobiomodulation to treat patients with dry age-related macular degeneration (AMD). Two clinical studies are evaluating approved intravitreal therapies for diabetic macular edema (DME). Reports of Toxic Anterior Segment Syndrome (TASS) with off-label compounded moxifloxacin have led the US Food and Drug Administration (FDA) to propose restricting its compounding, which in turn have led ophthalmic professional societies to protest this restriction. 1 One firm announced FDA approval of a new ophthalmic manufacturing facility—a process that took 5 years. There were several new corporate relationships announced in ophthalmology, confirming the continued perception that this is a valuable area. Finally, concern over the cost of medications for patients led the state of California to create partnerships with manufacturers for more affordable drugs.
Ophthalmic Pharmaceuticals and Biologics
Aerie received US FDA approval to use their facility in Athlone, Ireland, to produce their ocular hypotensive product, Rhopressa® (netarsudil ophthalmic solution, September 2020). This process took 5 years.
Alimera Sciences started enrollment in its NEW DAY clinical trial, a randomized controlled multicenter study of its Iluvien® (fluocinolone acetonide intravitreal implant) 0.19 mg as a baseline therapy in patients diagnosed with DME (September 2020).
Aura Biosciences started enrollment in a phase 2 study evaluating the safety and efficacy of suprachoroidal (SC) administration of AU-011 in patients with choroidal melanoma (September 2020).
Novartis announced results of its phase 3 KITE study of its brolucizumab versus aflibercept in patients with DME (September 2020).
SIFI announced results of a clinical study of its Netildex™ (netilmicin and tobramycin) gel after cataract surgery (September 2020).
Cell and Gene Therapy
Applied Genetic Technologies Corporation provided additional information about the design for a proposed phase 2/3 trial for its X-linked retinitis pigmentosa clinical program for its gene therapy (September 2020).
Gyroscope received fast-track designation from the FDA for its dry AMD gene therapy (September 2020).
REGENXBIO started enrollment in its AAVIATE trial, a phase 2 trial to evaluate the SC delivery of RGX-314 for the treatment of wet AMD (September 2020).
Ophthalmic Devices
LumiThera announced a collaboration with Diopsys in a planned clinical study to evaluate the ability of its photobiomodulation treatment using the Valeda Light Delivery System to improve electroretinogram outcomes in subjects with dry AMD (September 2020).
Ocular Therapeutix resolved a warning letter from FDA's Center for Device and Radiological Health (CDRH) regarding its Resure® sealant (September 2020).
Regulatory, Government, and Pharmaceutical Industry
Bausch Health entered into an agreement with Allegro Ophthalmics to acquire Allegro's ophthalmology assets, including its risuteganib and ALG-1007 (September 2020).
California enacted SB 852, which allows its Health and Human Services Agency (CHHSA) to enter into partnerships to increase patient access to affordable drugs (September 2020).
FDA is proposing restricting compounding of moxifloxacin for intraocular use at outsourcing facility use (503b; August 2020). Several ophthalmology professional societies (American Academy of Ophthalmology, American Society of Cataract and Refractive Surgery, American Glaucoma Society, American Association for Pediatric Ophthalmology and Strabismus, the American Society of Retina Specialists, the Retina Society, the Macula Society, and the Cornea Society) are working to prevent this restriction.
FDA is using an updated “Phonetic and Orthographic Computer Analysis” (POCA) Program to evaluate proposed brand names (August 2020).
Gilead received approval in Taiwan for the its remdesivir to treat COVID-19 (May 2019).
Santen will acquire Eyevance (September 2020).
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.