• DORC received notification from the FDA that its application for Orphan Drug Designation for a dual combination of Trypan Blue and Brilliant Blue G Ophthalmic Solutions has been granted. The proposed indication for the combination ophthalmic solution of 0.15% Trypan Blue and 0.025% Brilliant Blue G is to selectively stain the epiretinal membrane (ERM) and internal limiting membrane (ILM). The combination is intended to be injected onto the retinal surface, enabling both the ERM and ILM to be clearly stained and distinguished from unstained retina, thereby facilitating removal. If approved, this combination of Trypan Blue and Brilliant Blue G Ophthalmic Solution will be the first FDA approved product for this orphan indication.

• Glaukos Corp. entered into a collaboration and marketing agreement with Radius XR, whereby Glaukos will become the exclusive sales agent to market, promote and solicit orders for the Radius XR wearable patient engagement and diagnostic system within the United States. Radius will continue to lead development and commercialization efforts for Radius XR. The Radius XR platform is designed to enable efficient detection of eye disease and management and treatment of sight-threatening conditions. It combines medical-grade diagnostics, business management tools and patient education resources within a wearable spatial computing device. The system provides the tools for medical professionals to diagnose patients accurately, enhance patient engagement and reduce staff workload. In addition, patients can perform self-guided vision tests with minimal supervision. 

• Harrow announced an agreement under which it will acquire the US commercial rights for VEVYE (cyclosporine ophthalmic solution) 0.1%, a patented, non‑preserved, ophthalmic solution prescription drug based on Novaliq’s proprietary EyeSol water-free technology. VEVYE, which is dispensed topically in a 10 microliter per one drop and is labeled for twice‑daily dosing, is the first FDA-approved cyclosporine-based product indicated for the treatment of both signs and symptoms of dry eye disease with efficacy demonstrated after 4 weeks. Harrow also announced the signing of agreements with affiliates of Santen Pharmaceutical under which Harrow will acquire certain US commercial rights for the following branded products from Santen: FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, NATACYN (natamycin ophthalmic suspension) 5%, TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, ZERVIATE (cetirizine ophthalmic solution) 0.24% and FRESHKOTE.

• Visiox Pharma entered into a definitive agreement with Santen Pharmaceutical to license OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002%, a New Chemical Entity, which is indicated for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension that was approved by the FDA. Visiox plans to launch OMLONTI in early 2024, followed by once-daily PDP-716 (brimonidine) 0.35%. The strategic license provides exclusive rights in the United States for product manufacturing and commercialization of OMLONTI. Santen will receive an equity stake in Visiox as an upfront payment, and remains eligible to receive sales milestone payments, as well as royalties on net sales of OMLONTI in the United States.

• Sight Sciences announced positive results from SAHARA, a randomized controlled clinical trial comparing interventional eyelid procedures enabled by TearCare to Restasis for the treatment of dry eye. The SAHARA trial achieved its primary six-month endpoint, demonstrating the superiority of interventional eyelid procedures enabled by TearCare in the improvement of tear break up time, tear stability and the tear film’s ability to protect the ocular surface.

• The American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee released a notification to its members stating that it received physician reports of intraocular inflammation (IOI) following administration of Syfovre (pegcetacoplan injection), Apellis Pharamceuticals’ geographic atrophy drug that was approved by the FDA in February. In addition to cases of mild-moderate IOI, these reports also included cases of severe IOI, retinal vasculitis and occlusive retinal vasculitis. To date, The ASRS has received six cases of occlusive retinal vasculitis, and all events were observed after the first injection of Syfovre, between 7-13 days after drug administration, and with no specific lots implicated. ASRS stated that the etiology of these events is unclear, and outcomes in these patients are still evolving. According to Apellis, approximately 60,000 vials of Syfovre have been distributed since the FDA approval. Apellis stated it reviewed images and clinical data from all cases of IOI from their clinical trials and no cases of retinal vasculitis were found on secondary review of those patients. Apellis also stated that it is working closely with the ReST committee to follow these cases and plans to keep the retina community updated with available information. Practioners can report adverse events, here. The ASRS also encourages event reporting to Apellis and FDA MedWatch.

• Clearside Biomedical announced that enrollment and dosing of participants is underway in ODYSSEY, its randomized, Phase 2b clinical trial of CLS-AX (axitinib injectable suspension) in wet AMD. CLS-AX is a potent tyrosine kinase inhibitor combined with administration into the suprachoroidal space (SCS) behind the patient’s visual field using Clearside’s patented SCS Microinjector providing targeted delivery to the site of disease. A total of 60 participants are expected to be treated for 36 weeks and will be randomized to either CLS-AX (1 mg) or aflibercept (2 mg) with a 2:1 randomization schedule (40 participants in CLS-AX arm and 20 participants in aflibercept arm). The primary outcome measure is the mean change from baseline in BCVA. Secondary outcome measures include other changes from baseline in visual function and ocular anatomy, the need for supplemental treatment, and treatment burden as measured by total injections over trial duration. For more information about the trial, click here.

• OcuTerra Therapeutics announced full enrollment in the company’s Phase 2 DR:EAM clinical trial evaluating topically delivered OTT166 eyedrops in adult patients with moderately severe to severe non-proliferative diabetic retinopathy (DR) or mild proliferative DR with minimal vision loss. The trial is designed to assess the safety and efficacy of a high and low dose of daily topical administration of OTT166 vs vehicle. The trial enrolled 225 adult patients who were randomly assigned one of two doses of OTT166 or to one of two control groups receiving vehicle. OTT166 is a small molecule RGD integrin inhibitor delivered topically in the form of an eyedrop and is purpose-engineered to distribute to the retina in therapeutic concentrations. The primary efficacy endpoints for the trial are the proportion of patients with treatment-emergent adverse events and the proportion of participants who have improved by ≥ 2 steps from baseline in Diabetic Retinopathy Severity Scale, both at 24 weeks. Find more information about the DR:EAM clinical trial here.

• ChromaDex Corp. announced findings from two independent clinical study abstracts presented at the ARVO annual meeting and recently published in Investigative Ophthalmology & Visual Science. The results from these abstracts suggest that glaucoma patients have lower cellular NAD+ levels and thus replenishing NAD+ levels with a precursor, such as nicotinamide riboside (NR), may be a potential therapeutic strategy. The abstract titled “Primary open angle glaucoma patients (POAG) have lower systemic mitochondrial function, associated with lower systemic nicotinamide adenine dinucleotide (NAD) levels, compared to Controls” observed significantly lower cellular NAD+ levels and impaired mitochondrial function in patients with POAG. Higher NAD+ levels were strongly associated with higher mitochondrial function parameters, suggesting increased NAD+ levels are associated with improved energy production and cellular activity. This research is consistent with research from a study which includes preliminary data from a clinical study set to complete in 2024, titled “Nicotinamide Riboside for Progressing Glaucoma: A Double-blind, Parallel Group, Randomized, Placebo-controlled Trial – A Report on Neuroenhancement.” The data demonstrates that NR had beneficial effects in patients with progressing glaucoma by preventing visual field sensitivity decline, the company says.

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.