• Outlook Therapeutics announced the FDA accepted for filing a biologics license application for ONS-5010/LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD. The FDA set a Prescription Drug User Fee Act goal date of Aug. 29, 2023. ONS-5010, if approved, is expected to receive 12 years of regulatory exclusivity in the United States. In addition, Outlook and AmerisourceBergen recently announced a strategic commercialization agreement to expand the company’s reach for connecting to retina specialists and their patients. AmerisourceBergen will provide third-party logistics services and distribution as well as pharmacovigilance services in the United States. Through this agreement, Outlook expects to increase market access and distribution of ONS-5010.

• Nicox SA announced that once daily dosing of NCX 470 0.1% met the primary objective of non-inferiority in lowering IOP in the 691-patient Mont Blanc Phase 3 clinical trial in patients with open-angle glaucoma or ocular hypertension. The IOP-lowering effect from baseline for NCX 470 was 8.0 to 9.7 mm Hg. In a pre-specified secondary efficacy analysis of time-matched change from baseline IOP, statistical superiority was not achieved; however, the IOP reductions for NCX 470 were numerically greater at all six timepoints and statistically significant (p<0.049) at four of the six timepoints. NCX 470, a novel nitric oxide (NO)-donating bimatoprost eyedrop, is currently in a Phase 3 clinical program. The similarly designed, ongoing, second Phase 3 trial, Denali, is being conducted at clinical sites in the United States and China, with topline results expected after 2024.

• Vyluma Inc. reported topline results from its Phase 3 CHAMP clinical study. Analysis of this study, performed after 3 years of treatment and follow up demonstrates strong safety and efficacy for NVK002, a proprietary, investigational, low-dose, preservative-free atropine eyedrop, as a potential treatment for the progression of myopia in children. NVK002 at a dose of 0.01% atropine achieved statistically significant and clinically meaningful differences from placebo in every key outcome measure, including responder analysis, mean change from baseline in Spherical Equivalent Refraction and mean change from baseline in axial length at month 36. NVK002 at a dose of 0.02% demonstrated efficacy at several time points, including a statistically significant mean change in axial length compared to placebo at 36 months. NVK002 at both doses demonstrated strong safety and tolerability which were comparable to placebo. Vyluma plans to submit a new drug application for NVK002 to the FDA as early as Q1 2023. 

• Neurotech Pharmaceuticals reported positive topline results in two replicative Phase 3 clinical trials with its investigational encapsulated cell therapy for the treatment of Macular telangiectasia type 2 (MacTel), an orphan, slowly progressive degenerative disease of the macula that results in gradual deterioration of central vision. The studies were designed to evaluate the safety and efficacy of the investigational NT-501 implant and demonstrated statistical significance for the pre-specified primary endpoint: rate of change in ellipsoid zone area loss from baseline through 24 months. Primary results with the NT-501 implant demonstrated change in the rate of progression of disease in MacTel patients in two pivotal Phase 3 trials: 56.4% rate of reduction in Protocol A (p<0.0001) and 29.2% rate of reduction in Protocol B (p=0.021).

• Ocuphire Pharma announced the positive results in night vision disturbances patients from its earlier and first Phase 2 study evaluating the safety and efficacy of phentolamine mesylate eyedrops (Nyxol) have been peer-reviewed and published in BMC Ophthalmology. The manuscript titled “A randomized Phase 2 clinical trial of phentolamine mesylate eye drops in patients with severe night vision disturbances,” for clinical trial NCT04004507 and reported Nyxol was well-tolerated and effectively reduced pupil size with improvements in contrast sensitivity and visual acuity. In addition, Ocuphire is announcing a strategic business partnership with the American Society of Ophthalmic Administrators.

• UNITY Biotechnology announced that the key safety and efficacy endpoints were met at 24 weeks in the Phase 2 BEHOLD study of UBX1325 in patients with diabetic macular edema (DME). At 24 weeks after a single dose of UBX1325, the mean change in BCVA of UBX1325-treated subjects was an increase of +6.2 ETDRS letters, representing an improvement of +7.6 ETDRS letters compared to sham-treated subjects from baseline (p = 0.0084). In addition, patients treated with UBX1325 maintained central subfield thickness (CST) compared to sham-treated patients who demonstrated worsening of CST (ie, increased retinal thickness) through 24 weeks. Of patients treated with UBX1325, 59.4% did not require anti-VEGF standard of care through 6 months as compared to only 37.5% of sham-treated patients. The company intends to initiate a pivotal study in DME in the second half of 2023. For more, see the study results here.

• Sight Sciences announced International Ophthalmology published clinical data demonstrating the safety and effectiveness of the OMNI Surgical System as a minimally invasive, implant-free standalone glaucoma procedure for pseudophakic glaucoma patients with a history of trabecular microbypass stent implantation whose pressure is no longer controlled by the bypass stent and IOP-lowering medications. Despite glaucoma medications and prior microbypass stenting, target IOP may no longer be achieved over time. During 3 to 42 months follow-up, the majority of these standalone study patients treated with OMNI regained IOP control and avoided traditional surgery. For more, see the study results here.

• KYS Vision announced clinical trial results of its Macustat macular function scan for the remote monitoring of central retinal function. In the clinical study, 50 eyes were evaluated with the self-administered Macustat test and compared to office-based retinal examination, which included OCT imaging of the retina. With the self-test, 96% of eyes registered central retina acuity within 0.2 LogMAR of office acuity measurement while the performance efficacy for the detection of macular function defects such as metamorphopsias and scotomas exceeded 90%. For more, see the study results here.

• Prevent Blindness has declared November as Diabetes-related Eye Disease Month. As part of this effort, a new episode of the Prevent Blindness Focus on Eye Health Expert Series dedicated to diabetes-related eye disease and health disparities will be available during November. In addition, Prevent Blindness is featuring other resources, including the Diabetes & the Eyes Educational Toolkit (available in English and Spanish), which includes educational resources, Power Point presentations, shareable social media graphics and a dedicated webpage. Fact sheets, including the new “Diabetes-related Eye Disease and Mental Health” fact sheet are also available. For more information about additional resources available from Prevent Blindness, click here. 

• Replay, a genome writing company reprogramming biology by writing and delivering big DNA, announced the launch of Eudora, an HSV gene therapy company targeting genetic retinal diseases. It is the first of Replay’s product companies to leverage its high payload capacity herpes simplex virus (HSV) delivery vector, synHSV, a high payload capacity gene-deleted HSV-1 vector capable of delivering up to eight times the payload of adeno-associated virus (AAV) vectors. Eudora’s pipeline includes retinitis pigmentosa, Stargardt disease and Usher syndrome type 1B. Additionally, Replay is developing an HSV vector that can deliver up to 30 times the AAV payload. 

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.