• RetinalGeniX Technologies was granted a patent for its Patient Home Monitoring and Integrated Physician Alert System for Ocular Anatomy. The invention relates to a home monitoring device deployed in the patient's home, from which an alert can be sent to a remotely located physician, who can then perform a pre-diagnostic evaluation remotely to assess whether an in-person medical diagnosis is warranted. Working in concert with RetinalGeniX's DNA/GPS technology, the newly patented system may aid in the early diagnosis of systemic disease through high-resolution remote retinal imaging and in-home real-time monitoring. 

• Harrow announced the completion of the transfer to Harrow of the new drug application (NDA) for VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eyedrop for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. The US commercial rights to VIGAMOX were purchased by Harrow in January 2023. VIGAMOX is the fourth FDA-approved ophthalmic product from that acquisition to have completed the NDA transfer process and become commercially available under the Harrow name. Product orders for VIGAMOX can be made directly through Harrow’s customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.

• Apellis Pharmaceuticals provided an update on July 29 of its review of rare events of retinal vasculitis reported in real-world treatment with SYFOVRE (pegcetacoplan injection), the first FDA approved treatment for geographic atrophy (GA) secondary to AMD. As part of the company’s ongoing review, there has been no indication that drug product or manufacturing issues contributed to rare events of retinal vasculitis, and there were zero events reported in clinical trials, following more than 23,000 clinical trial injections to date. Since launch, Apellis has confirmed seven total events of non-occlusive/occlusive retinal vasculitis. As of July 29, more than 68,000 vials of SYFOVRE have been distributed since FDA approval.

• Apellis reported data at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting that reinforced the long-term efficacy and safety of SYFOVRE. Data was presented from the GALE extension study following 30 months of continuous treatment with SYFOVRE. In GALE, SYFOVRE reduced GA lesion growth with both monthly (39%; p<0.0001) and every-other-month (EOM) (32%; p<0.0001) treatment between Months 24 and 30 compared to the projected sham arm (all p-values nominal). Additionally, SYFOVRE reduced nonsubfoveal GA lesion growth with monthly (45%; p<0.0001) and EOM (33%; p=0.0023) treatment between Months 24 and 30 compared to the projected sham arm. The safety profile of SYFOVRE in the GALE study continued to be consistent with previously reported Phase 3 data.

• Eyenovia Inc. announced the first commercial sale of Mydcombi (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis to board-certified ophthalmologist Dr. Nathan M. Radcliffe. Dr. Radcliffe is the first physician in the United States to incorporate Mydcombi into a daily practice. Mydcombi represents the first FDA-approved and commercially available fixed combination of tropicamide and phenylephrine for pupil dilation. Mydcombi was approved by the FDA on May 8, 2023.

• Clearside Biomedical presented safety and tolerability data from its recent OASIS clinical trial of CLS-AX (axitinib injectable suspension) at the ASRS Annual Scientific Meeting. The presentation, entitled, “Safety and Tolerability of Suprachoroidal Injection of CLS-AX in Neovascular AMD Patients With Persistent Activity After Anti-VEGF Therapy” included data from the OASIS Phase 1/2a clinical trial and Extension Study highlighting the safety profile. The data showed no serious adverse events, no adverse events from inflammation, no vasculitis or vascular occlusion and no treatment emergent adverse events related to study treatment. The presentation described the results from the 6-Month Extension Study at higher doses in Cohort 3 and Cohort 4. These cohorts showed signs of durability and a 77%-85% reduction in treatment burden. Additionally, signs of biologic effect with stable mean BCVA and stable mean central subfield thickness to the 6-month timepoint were seen in these cohorts.

• The FDA cleared Skyline Therapeutics’ investigational new drug (IND) application for a Phase 1/2a clinical trial of SKG0106, a one-time intravitreally delivered AAV gene therapy for the treatment of neovascular AMD. The company reported that the global Phase 1 clinical trial will be initiated soon. In comprehensive preclinical studies, SKG0106 demonstrated potent efficacy of inhibition of intraocular neovascularization, a favorable safety profile and long-lasting durability following a single intravitreal administration.

• Vantage Surgical Solutions, a provider of mobilized surgical solutions, announced its acquisition of Ophthalmic Surgical Solutions (OSS), a company specializing in ophthalmic surgical equipment and services. Through the support of Pharos Capital Group, the acquisition of OSS unites two companies with more than 40 years of combined experience bringing ophthalmic surgery access to rural communities through partnerships with hospitals and ASCs. The companies plan to enhance their capabilities, expand their product offerings, and provide the scale and synergies necessary to reach a broader national audience. 

• ProQR Therapeutics and Laboratoires Théa announced an agreement in which ProQR will divest its late-stage ophthalmic assets, sepofarsen and ultevursen, to Théa. The agreement provides ProQR with initial payment of €12.5M and up to €135M in further payments, as well as potential additional earn outs based on commercial sales in the United States and EU. Sepofarsen (QR-110) is an investigational RNA therapy designed to restore vision in Leber congenital amaurosis 10 due to the c.2991+1655A>G mutation (p.Cys998X) in the CEP290 gene. Ultevursen is an investigational RNA therapy designed to address the underlying cause of vision loss in Usher syndrome type 2a and non-syndromic retinitis pigmentosa due to mutations in exon 13 of the USH2A gene.

• OKYO Pharma announced an agreement with Tufts Medical Center to conduct a 40-patient open-label clinical trial to evaluate the efficacy and safety of OK-101 in patients with neuropathic corneal pain (NCP). The IND application for NCP is planned to be filed in Q4 2023, with study enrollment planned to commence shortly after IND allowance by the FDA. The open-label trial will provide an opportunity to evaluate the safety and efficacy of OK-101 in a real-world clinical setting and is anticipated to take 6-9 months to conduct. This collaborative effort is focused on evaluating OK-101 as a potential non-opioid analgesic to reduce neuropathic corneal pain. A second clinical indication for OK-101 is currently in a 240 patient Phase 2 clinical trial to treat dry eye disease, with top-line data anticipated by end of 2023.

• Prevent Blindness declared August Children’s Eye Health and Safety Month in an effort to educate parents and caregivers on ways to keep children’s eyes healthy. Prevent Blindness offers free resources, including fact sheets and social media graphics in English and Spanish, toolkits, and webpages on a variety of topics, including myopia, amblyopia, strabismus, eye safety in relation to digital screen time, importance of vision screenings, financial assistance programs, and more. Additionally, Prevent Blindness is debuting a new episode in the online Focus on Eye Health Expert Series, “Children’s Vision and Eye Health,” featuring R.V. Paul Chan, MD, MSC, MBA, FACS. Also, on Aug. 22, 2023 at 7 p.m. EST, a new episode dedicated to the discussion of progressive myopia from the “Seeing Eye to Eye: Celebrating Eye Health” Facebook Live series from Blackdoctor.org will be held. The episode will feature Terri L. Young, MD, MBA, FARVO and Afua Oteng Asare, OD, PhD. And, in advance of the upcoming solar eclipses on Oct. 14, 2023, and April 8, 2024, Prevent Blindness offers the “Solar Eclipse Viewing Party Family and Children’s Toolkits,” available free for download. For additional resources from Prevent Blindness, click here.  

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.