• Glaukos Corp. announced positive topline data for both Phase 3 pivotal trials of iDose TR that successfully achieved its pre-specified primary efficacy endpoints through 3 months in both Phase 3 trials and demonstrated excellent tolerability and a favorable safety profile through 12 months. Ninety-three percent of slow-release iDose TR subjects remained well-controlled on the same or fewer IOP-lowering topical medications at 12 months compared to screening after a single administration of iDose TR, vs 67% of timolol control subjects in both Phase 3 trials. Glaukos plans to move forward with its plans for a new drug application (NDA) submission to the FDA for the slow-release iDose TR model, with an expected FDA review and decision completed by the end of 2023.

• Regeneron Pharmaceuticals announced the primary endpoints were met in two pivotal trials investigating novel aflibercept 8 mg with 12- and 16-week dosing regimens in patients with diabetic macular edema (DME) and wet AMD. The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen. Ninety-one percent and 89% of DME patients were rapidly initiated and maintained on 12- and 16-week dosing intervals through week 48, respectively, and 79% and 77% of wet AMD patients were rapidly initiated and maintained on 12- and 16-week dosing intervals through week 48, respectively. In these trials, the safety of aflibercept 8 mg was consistent with the established safety profile of EYLEA.

• Tarsus Pharmaceuticals submitted an NDA to the FDA for TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment of Demodex blepharitis, a highly prevalent eyelid margin disease that does not have any FDA-approved treatment options. The NDA submission includes the positive results from the two pivotal trials (Saturn-1 and Saturn-2) collectively involving more than 800 patients in which TP-03 met all endpoints and was well-tolerated. TP-03 is now also being studied for the treatment of meibomian gland disease in patients with Demodex mites. 

• Bausch + Lomb released survey results from the company's first annual Visionary Report, which was designed to identify new key insights into the value Americans place on their eyesight, as well as the “blind spots” that may exist in the understanding and awareness of AMD. Most notably in the report, 81% of US adults surveyed would be willing to give up something else that is important — going on vacation, a million dollars, the internet, listening to music, the ability to remember people's names or another one of their senses — if it meant never losing their eyesight. Despite this clear prioritization of the ability to see, only 37% of US adults 50+ surveyed know that AMD is a very real threat as a leading cause of vision loss for Americans. The 2022 Visionary Report is accessible here.

• Ocuphire Pharma announced that the FDA granted a small business waiver of the Prescription Drug User Fee Act fee of $3.1 million for the 505(b)(2) NDA for Nyxol (phentolamine ophthalmic solution), the company’s late-stage product candidate. Ocuphire remains on track to file the NDA for Nyxol in its first indication, reversal of mydriasis, in late 2022.

• Researchers from the National Eye Institute, part of the National Institutes of Health, developed a gene therapy that rescues cilia defects in retinal cells affected by a type of Leber congenital amaurosis (LCA), a disease that causes blindness in early childhood. Using patient-derived retina organoids (also known as retinas-in-a-dish), the researchers discovered that a type of LCA caused by mutations in the NPHP5 (also called IQCB1) gene leads to severe defects in the primary cilium, a structure found in nearly all cells of the body. The findings not only shed light on the function of NPHP5 protein in the primary cilium but also led to a potential treatment for this blinding condition.

• Nanoscope Therapeutics announced full enrollment of its Phase 2 clinical trial of MCO-010, an ambient-light activatable Multi-Characteristic Opsin (MCO) optogenetic monotherapy to restore vision in blind patients, for Stargardt disease. Six-month data from the Phase 2 STARLIGHT trial are expected in H1 2023. Nanoscope's optogenetic therapy uses a proprietary AAV2 vector to deliver MCO genes into retinal cells to enable vision in different color environments. The therapy is administered as a single intravitreal injection for in-office delivery without the need for any other devices or interventions. MCO-010 has received orphan drug designations for retinitis pigmentosa (RP) and Stargardt disease from the FDA and is concurrently being evaluated in Nanoscope's Phase 2b RESTORE trial in patients with RP, with trial results also expected in H1 2023. 

• Sight Sciences announced the completion of enrollment in the SAHARA Trial, a first of its kind outcomes study designed to evaluate whether an interventional dry eye procedure with the TearCare System is superior in alleviating the signs and symptoms of dry eye disease. Primary endpoints measured by a masked assessor at 6 months include changes from baseline of tear breakup time (sign) and ocular surface disease index score (symptom). Results from the 310-patient, 1:1 randomized SAHARA trial are expected to be available in late Q2 2023.

• Haag-Streit opened a new microscope production site in Aesch, Switzerland. In September 2021, Haag-Streit decided to reposition itself in the field of surgical microscopes and focus solely on ophthalmology and the production and future development of the Hi-R NEO 900 microscope, as well as the next generation of ophthalmic surgical microscopes. In conjunction with this strategic decision, Haag-Streit moved the production of its surgical microscopes from Wedel, Germany to Aesch, Switzerland, and transferred the responsibility for production to Haag-Streit Diagnostics in Koeniz, Switzerland. Haag-Streit says this allows the company to bundle its existing competencies in ophthalmic diagnostics and surgery and helps to better align processes in areas such as supply chain, production and quality assurance.

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.