• Bausch + Lomb and Novaliq GmbH announced that the FDA has accepted the new drug application filing for investigational treatment NOV03 (perfluorohexyloctane). A potential first-in-class eyedrop with a novel mechanism of action, NOV03 is an investigational therapy to treat the signs and symptoms of dry eye disease associated with meibomian gland dysfunction. NOV03 has been assigned a Prescription Drug User Fee Act action date of June 28, 2023.

• IVERIC bio reported positive topline results from GATHER2, the company’s second Phase 3 clinical trial of Zimura (avacincaptad pegol), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA). GATHER2 met its primary endpoint with 14.3% reduction (p-value = 0.0064) in mean rate of growth (Slope) in GA area over 12 months using square root transformation; 17.7% reduction (p-value = 0.0039) using observed GA area. The company plans to submit a new drug application to the FDA by the end of the first quarter 2023. 

• Oculis S.A. announced that data for the Phase 2 DX-211, a randomized, double blinded, multi-center and vehicle controlled clinical trial assessing the safety and efficacy of topical OCS-01 patients with diabetic macular edema (DME), was published in Acta Ophthalmologica. The dataset shows OCS-01 to be superior to vehicle in the primary efficacy analysis of BCVA change from baseline with a between group difference of +1.58 ETDRS letters at the pre-specified significance level of 0.15. OCS-01 is currently under investigation for the treatment of DME in the ongoing Phase 3 DIAMOND trial to confirm these findings in a larger patient population. The publication is accessible here.

• At the National Institutes of Health, a surgical team successfully implanted a patch of tissue made from patient cells with the goal of treating advanced dry AMD, also known as GA. The patient received the therapy as part of a clinical trial that is the first in the United States to use replacement tissues from patient-derived induced pluripotent stem cells. The procedure was performed at the NIH Clinical Center in Bethesda, Md., under a Phase 1/2a clinical trial to determine the therapy’s safety. 

Quick Notes is published weekly. Unless otherwise noted, the information presented is based on press releases. Find earlier editions here. To submit a press release to be considered for publication, click here.