Abstract
In this review period, there was a marketing approval for an intravitreal formulation of bevacizumab. Several new products ranging from anterior to posterior segment completed enrollment in clinical studies, suggesting that after dosing and follow-up, results will be forthcoming. Business development continues in ophthalmic medical devices and pharmaceuticals, suggesting the interest of these novel therapies and diagnostics to the health care industry.
Ophthalmic Pharmaceuticals and Biologics
Aldeyra completed enrollment in a Phase 3 dry eye chamber clinical trial of topical ocular 0.25% reproxalap for the treatment of dry eye disease (June 2024).
Clearside Biomedical with its partner, Arctic Vision, reported results from its phase 3 clinical trial of Arcatus (ARVN001, triamcinolone acetonide suprachoroidal injectable suspension) for the treatment of uveitic macular edema in China (July 2024).
Genentech announced FDA approval of Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet AMD, diabetic macular edema (DME), and macular edema after retinal vein occlusion (RVO, July 2024).
Nicox announced complete entry for its Denali trial of NCX 470 in patients with open-angle glaucoma or ocular hypertension (July 2024).
Novaliq received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its Vevizye® (cyclosporine) intended for the treatment of moderate to severe dry eye disease (July 2024).
NurExone Biologic is in preclinical development of its exosome-based therapies to regenerate damaged optic nerves (July 2024).
Ocular Therapeutix commenced enrollment in its phase 3 SOL-R clinical trial evaluating repeat dosing of Axpaxli (axitinib intravitreal implant, also known as OTX-TKI) for the treatment of patients with wet AMD (August 2024).
Okyo Pharma is planning to conduct a Phase 2 study of its OK-101 in a Phase 2 study of patients with neuropathic corneal pain in DED patients. OK-101 is a lipid conjugated chemerin peptide, which has agonistic activity at the ChemR23 G-protein coupled receptor (July 2024).
Outlook Therapeutics received marketing authorization from the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) for its Lytenava™ (bevacizumab gamma) for the treatment of wet AMD (July 2024).
Sydnexis announced results from its three-year STAR trial of topical atropine to slow pediatric myopia (July 2024).
Gene and Cell Therapy
Beacon Therapeutics is continuing to evaluate its AGTC-501 (laruparetigene zovaparvovec) retinal gene therapy for patients with X-linked retinitis pigmentosa, and generate data for a planned dry AMD study (July2024).
Medical Devices
Balance Ophthalmics received DeNovo Classification of its FYSX Ocular Pressure Adjusting Pump from the U.S. FDA for the treatment of patients with glaucoma (June 2024).
Bausch + Lomb acquired Trukera Medical, manufacturer of the ScoutPro device, which is designed to measure osmolarity (July 2024).
Regulatory, Government, and Pharmaceutical Industry
ANI Pharmaceuticals entered into an agreement with Alimera to acquire the company, including its ophthalmic drug delivery products (June 2024).
There is a growing concern over the roles of pharmacy-benefit managers in the U.S. health care system (July 2024). 1
The American Academy of Neurology lead journal announced that “after consideration and discussion among editors, journal staff, and the publisher of the journal, we decided that we could better serve authors and readers by replacing the short form version of the research article in the print journal with its structured abstract.” This is the end of a unique experiment started in 2018 to have the journal’s editors prepare a special short form of a paper (July 2024). 2
The U.S. FDA issued a guidance regarding Addressing Misinformation About Medical Devices and Prescription Drugs (July 2024).
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.