• Bausch + Lomb introduced new surgical planning software for the Eyetelligence platform. The new software is designed to streamline surgical planning, information flow and enable EMR and diagnostic device integration. Surgeons will also be able to work with various EMR and diagnostic platforms, eliminating the need to purchase specific equipment or train staff on new technologies. The software will feature both a surgeon-focused app and a nursing-focused app that will provide access to critical, timely data related to the patient and procedure, while enhancing communication and helping to improve workflow. In addition, the Eyetelligence platform includes software to connect to Bausch + Lomb’s Stellaris Elite Vision Enhancement System. 

• Harrow announced the completion of the transfer to Harrow of the new drug applications (NDAs) for five products: FLAREX, NATACYN, TOBRADEX ST, VERKAZIA and ZERVIATE. FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is a corticosteroid indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the eye. NATACYN (natamycin ophthalmic suspension) 5% is a sterile antifungal for treating fungal blepharitis, conjunctivitis and keratitis caused by susceptible organisms, including Fusarium solani keratitis. TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05% is an antibiotic and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. VERKAZIA (cyclosporine ophthalmic emulsion) 0.1% is a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis in children and adults and holds orphan-drug exclusivity. ZERVIATE (cetirizine ophthalmic solution) 0.24% is a histamine-1 receptor.

• Apellis Pharmaceuticals announced The Lancet published the positive 24-month results from the Phase 3 OAKS and DERBY multicenter, randomized, double-masked, sham-controlled studies evaluating SYFOVRE (pegcetacoplan injection) for geographic atrophy (GA) secondary to AMD. According to the study results, both every-other-month and monthly SYFOVRE showed a clinically meaningful reduction of GA lesion growth with increasing effects over time and a well-demonstrated safety profile in a broad population of more than 1,200 patients. 

• Stuart Therapeutics entered into a license agreement with Glaukos Corp. under which it has granted Glaukos exclusive worldwide rights to develop and commercialize Stuart's proprietary ST-113 drug candidate for neuroprotection in glaucoma. ST-113 is a patented pre-clinical asset that has demonstrated the ability to provide neuroprotection and neuro-repair of optic nerve axons in animal testing. Its therapeutic approach to glaucoma is independent of control of IOP, which may provide a solution to normal tension glaucoma. Under the agreement, Stuart will receive an upfront payment and is eligible for additional development and sales-related milestone payments, plus royalties. Glaukos will assume all costs for development of ST-113.

• The FDA granted clearance for Endogena Therapeutics’ investigational new drug (IND) application, allowing for the clinical investigation of EA 2351 for patients with GA. The first-in-human study is set to commence in 2024. This is the company’s second program to progress into clinical trials, building on the momentum of its ongoing EA 2353 program for retinitis pigmentosa, initiated in July 2022. EA-2351 and EA-2353 each target specific cell populations through different pathways. While EA-2353 focuses on activating one set of cells in the context of retinitis pigmentosa, EA-2351 centers on retinal pigment epithelial cells, which play a pivotal role in regenerating and restoring photoreceptor function. 

• According to a report by Fierce Pharma, Roche is stopping the development of CB2 agonist vacasinabin (RG7774), an oral drug candidate for the treatment of non-proliferative diabetic retinopathy (DR). According to Fierce Pharma, the clinical trial, which was completed in July, failed to convince the company to keep investing in RG7774. The study's main purpose was to assess the safety, tolerability and effect of oral administration of RG7774 on the severity of DR in participants with moderately severe to severe non-proliferative DR and good vision.

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.