• Tarsus Pharmaceuticals announced the FDA accepted its new drug application (NDA) for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis, with a Prescription Drug User Fee Act target action date of Aug. 25, 2023. Tarsus also announced the launch of a disease education program, a field medical team and payor engagement in anticipation of the TP-03 launch.

• IVERIC bio submitted the first part of its NDA for rolling review to the FDA for avacincaptad pegol (ACP, Zimura), a novel investigational complement C5 inhibitor, for the treatment of geographic atrophy (GA) secondary to AMD. As previously announced, the company received Fast Track designation from the FDA for ACP. Following receipt of the topline GATHER2 data, the company shared the data with the FDA. Based on the pivotal clinical trials, GATHER1 and GATHER2, which both met their primary endpoint in slowing GA progression with statistical significance at the 12-month time point, the company requested rolling submission of its planned NDA, which the FDA granted.

• Oyster Point Pharma entered into a definitive agreement under which Viatris Inc., a global health-care company, would acquire Oyster Point Pharma. Viatris says it intends to acquire Oyster Point Pharma as the foundation of its new ophthalmology franchise, recognizing its team, the strength of TYRVAYA (varenicline solution) Nasal Spray and Oyster Point Pharma’s pipeline. Under the terms of the agreement, Viatris will commence a tender offer to purchase all outstanding shares of Oyster Point Pharma for $11.00 per share in cash at closing, plus a contingent value right for a potential cash payment of up to $2.00 per share upon achievement of specified performance targets by Oyster Point Pharma for full year 2022. 

• After presenting positive interim data from its ongoing Phase 2 trial, Aura Biosciences has aligned with regulatory agencies and finalized the design of the global Phase 3 trial, which will evaluate the efficacy and safety of belzupacap sarotalocan (bel-sar) with suprachoroidal administration for the first-line treatment of early-stage choroidal melanoma. The Phase 3 trial has a three-arm randomized and masked design, where the primary analysis will compare bel-sar to sham. 

• REGENXBIO Inc. announced additional positive interim data from the ongoing Phase 2 ALTITUDE trial of RGX-314 for the treatment of diabetic retinopathy (DR) without center-involved diabetic macular edema (CI-DME) using in-office suprachoroidal delivery. RGX-314 is being investigated as a potential one-time gene therapy for the treatment of wet AMD, DR and other chronic retinal conditions. As of October 17, 2022, RGX-314 continued to be well-tolerated with no drug-related serious adverse events and more than half of patients across two dose levels reported clinically meaningful improvement in disease severity, seeing improvement from baseline in their DRSS scores. The ALTITUDE trial has also been expanded to include a higher third dose level, with patients stratified by DRSS levels across cohorts and short-course prophylactic ocular steroids following RGX-314 administration. For more, see the presentation of study results here.

• Harrow announced the launch of atropine.com, an ordering and marketing portal designed specifically for prescribers interested in compounded atropine formulations. All atropine.com prescriptions will be dispensed through Harrow’s wholly owned subsidiary, ImprimisRx. Compounded atropine formulations are at a biologically comfortable pH, are available in three concentrations (0.01%, 0.025%, and 0.050%) and are available for individual patients through the ImprimisRx 503A national mail-order pharmacy. The company intends to make a patent-pending suite of compounded atropine formulations that do not require either preservatives or boric acid, and the product suite will soon be available through the ImprimisRx 503B outsourcing facility, with or without a patient-specific prescription. Physicians can prescribe atropine online at atropine.com or by calling ImprimisRx customer care.

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.