Abstract
In this review period, there was substantial activity in phase 2 and phase 3 clinical trials for novel therapeutics for dry eye disease, neuropathic pain, and choroidal neovascularization due to age-related macular degeneration (wet AMD) and diabetic eye disease (gene therapy, drug delivery systems for approved small molecules, and novel large and small molecules). A novel ophthalmic formulation of clobetasol propionate was approved by the U.S. FDA for the treatment of postoperative inflammation and pain after ocular surgery.
Ophthalmic Pharmaceuticals and Biologics
AffaMed Therapeutics' new drug application for Dextenza® (0.4 mg dexamethasone ophthalmic insert) for the treatment of ocular inflammation and pain after ophthalmic surgery, and ocular itching associated with allergic conjunctivitis was accepted for review by the Singapore Health Sciences Authority (February 2024).
Exonate announced data from a phase 1b/2a trial for its small molecule SRPK1 inhibitor EXN407 for the treatment of diabetic eye disease (March 2024).
Eyebio announced results from the phase 1b/2a AMARONE trial of its Restoret™ (a trispecific Wnt agonist antibody) in patients with treatment-naïve diabetic macular edema and treatment-naïve wet AMD (February 2024).
Formosa Pharmaceuticals received U.S. FDA approval for its topical clobetasol propionate ophthalmic suspension 0.05% for the treatment of postoperative inflammation and pain after ocular surgery. The firm has partnered with Eyenovia for U.S. marketing (March 2024).
Innovent Biologics announced results for a phase 3 registrational study (RESTORE-1) of its IBI311, a recombinant anti-insulin-like growth factor 1 receptor antibody in Chinese subjects with thyroid eye disease (February 2024).
iView Therapeutics received U.S. FDA clearance for its investigational new drug application for its topical IVW-1001, a TRPM8 agonist, to treat signs and symptoms of dry eye disease (March 2024).
Ocular Therapeutix commenced enrollment in the phase 3 SOL-1 clinical trial of Axpaxli (axitinib intravitreal implant, OTX-TKI) for the treatment of wet AMD under a special protocol assessment with FDA (February 2024).
OKYO received U.S. FDA clearance for a phase 2 study of its OK-101, a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein-coupled receptor, for the treatment of neuropathic corneal pain (February 2024).
Opthea completed enrollment in the COAST phase 3 trial of its sozinibercept (OPT-302, a vascular endothelial growth factor-C/D inhibitor) for the treatment of wet AMD (February 2024).
Palatin presented results on the PL9643 MELODY-1 phase 3 trial for its melanocortin receptor modulator in the treatment of dry eye disease (February 2024).
Sylentis announced results from the phase 3 SYL10111_V study of its RNAi tivanisiran in the treatment of dry eye disease associated with Sjögren's syndrome (February 2024).
Telios announced results from a phase 2 study of TL-925, a topical Bruton's tyrosine kinase inhibitor, for the treatment of dry eye disease (March 2024).
Gene and Cell Therapy
Adverum announced data from the phase 2 LUNA trial of its ixoberogene soroparvovec intravitreal gene therapy for wet AMD (February 2024).
Regulatory, Government, and Pharmaceutical Industry
Emmecell has entered a business relationship with the global nonprofit eyebank Eversight for the development of its cell therapy for the treatment of corneal disease (February 2024).
The U.S. FDA issued a guidance for conducting remote regulatory assessments (January 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.
Funding Information
No funding was received for this work.