Abstract
In this review period, several firms announced results from mid- to late-stage clinical evaluation of novel therapeutics for glaucoma and a range of degenerative retinal diseases. As well, novel ophthalmic treatments continue to be of financial value as evidenced by licensing agreements. While not directly related to ophthalmology but of impact on many patients is a genetic/omics approach to resolving a potential serious food-drug interaction.
Ophthalmic Pharmaceuticals and Biologics
Alkeus announced results from its TEASE-3 study of its oral gildeuretinol in patients with Stargardt disease (January 2025).
EyePoint announced results for the ongoing phase 2 VERONA clinical trial evaluating its Duravyu™ (vorolanib intravitreal insert) for diabetic macular edema (DME, February 2025).
Formycon and its licensing partner Klinge Biopharma announced that the European Commission granted central marketing authorization for FYB203 (aflibercept), a biosimilarto Eylea, under the brand names Ahzantive and Baiama (January 2025).
Genentech’s Susvimo® ocular implant (ranibizumab) was approved by the U.S. FDA for the indication of treatment of DME (February 2025).
Inflammasome Therapeutics reported results from a clinical trial of its Kamuvudine-8 implant in patients with geographic atrophy (GA, January 2025).
Nacuity received Fast Track Designation for its NPI-001 (N-acetylcysteine amide) oral tablets for the treatment of patients with retinitis pigmentosa (RP, January 2025).
Outlook Therapeutics presented results from its NORSE EIGHT trial of its intravitreal ONS-5010 (bevacizumab-vikg) for treatment of neovascular age-related macular degeneration (AMD, January 2025).
Qlaris presented results from 2 U.S. Phase 2 clinical trials investigating its QLS-111 in patients with primary open angle glaucoma and ocular hypertension (February 2025).
Regeneron announced results from its Phase 3 QUASAR trial of Eylea HD® for treatment of macular edema due to retinal vein occlusion (February 2025).
SeaBeLife announced preclinical in vivo results for its SBL03 drug candidate in a model of retinal cell death in GA (January 2025).
Sling Therapeutics announced results from a phase 2b/3 LIDS trial of its linsitinib in patients with active, moderate-to-severe thyroid eye disease (January 2025).
Tenpoint Therapeutics reported results from BRIO-II, its phase 3 pivotal trial of Brimochol PF for treatment of presbyopia (January 2025).
Gene and Cell Therapy
Abbie and Regeneron are continuing to develop its ABBV-RGX-314 suprachoroidal gene therapy for the treatment of neovascular age-related macular degeneration (wet AMD) and diabetic retinopathy (January 2025).
Regulatory, Government, and Pharmaceutical Industry
Bausch + Lomb announced three licensing agreements: Whitcup Biosciences (two therapies for potential use in glaucoma and geographic atrophy (GA), City Therapeutics (an RNA interference (RNAi)-based medicine for the treatment of retinal diseases including GA, and InflammX (an oral treatment for AMD and diabetic retinal disease (January 2025).
The International Conference on Harmonisation published a guideline on model-informed drug development (M15, November 2024).
The food-drug interaction of commonly used statins and furanocoumarins in grapefruit is well known. Goldenberg et al. used a genetic/omics approach to create a hybrid grapefruit that does not contain these molecules, thus obviating this food-drug interaction. 1
The U.S. federal government has instructed government scientists to retract papers with selected terms. The International Committee of Medical Journal Editors restated their policy on journal response to such requests. The British Medical Journal restated their policy that retraction is not a unilateral author decision. 2 In related federal activities, federal scientists have been prohibited from speaking in public meetings, federal websites have deleted certain information, and the implications of tariffs on medication availability and cost are being conveyed by manufacturers (February 2025).
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.
Funding Information
No funding was received for this article.