Praetego Inc. has been granted a US$300,000 phase I Small Business Technology Transfer Research (STTR) award by the National Eye Institute (NEI) to advance the company's lead candidate, PTG-630, into preclinical proof of concept in diabetic retinopathy.
Ophthalmic startup Eluminex Biosciences Ltd. closed a $40 million series B round to progress its pipeline of ophthalmic assets and recombinant human collagen technology. Eluminex’s pipeline includes multi-targeted antibody molecules for vision-threatening retinal diseases and an oral small molecule for rare inherited pediatric retinal dystrophies, but its lead asset, EB-301, is a biosynthetic cornea derived from recombinant human type III collagen.
Aldeyra Therapeutics Inc. is eyeing the start of clinical trials with reactive aldehyde species (RASP) modulators ADX-246 for systemic immune-mediated diseases and ADX-248 for geographic atrophy.
After a delay in November that resulted in a new PDUFA date, Apellis Pharmaceuticals Inc.’s Syfovre (pegcetacoplan injection) received U.S. FDA approval for treating geographic atrophy (GA) secondary to age-related macular degeneration. While this is the first and only FDA-approved treatment for GA, there is competition afoot from Belite Bio Inc. and Iveric Bio Inc. The intravitreal targeted C3 therapy’s Feb. 17 approval of the priority NDA came more than a week ahead of its Feb. 26 PDUFA.
Akari Therapeutics plc has advanced its preclinical development program for long-acting PAS-nomacopan for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The company has produced new and promising versions and progressed from lab scale to pre-GMP optimization, and is targeting an IND application to the FDA in the first half of next year.
A phase IIb clinical study has Frequency Therapeutics Inc. reeling and making big changes, including layoffs. The placebo-controlled phase IIb study of FX-322 in treating acquired sensorineural hearing loss by regenerating hair cells in the cochlea missed its primary efficacy endpoint, so the company is discontinuing the program. It’s also shutting down a phase Ib study of FX-345, a program for treating the same indication.
Eyenuk Inc. is significantly extending the scope of its artificial intelligence system for the automatic analysis of retinal images, adding the diagnosis of age-related macular degeneration (AMD) and glaucoma to the EU approved uses of Eyeart AI.
The U.S. FDA inked a Dec. 20, 2022, warning letter to Righteye LLC that handed the company a list of quality system issues in dire need of redress, but the agency was more concerned about off-label promotion of the Righteye vision system as a method for evaluating the patient’s ocular tremors as a sign of Parkinson’s disease.
Researchers from Curacle Co. Ltd. and Yonsei University have published preclinical data for the endothelial dysfunction blocker CU06-1004 from studies assessing it in models of retinal vascular disease.
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