Eyeworld Daily News

22 | EYEWORLD DAILY NEWS | APRIL 22, 2022 ASCRS ANNUAL MEETING DAILY NEWS sphincter without causing myopic shift, leaving the ciliary muscle almost com- pletely untouched. Studies have shown that this drop achieves a 1.5 mm pupil within 30 minutes, with 2 mm main- tained out to 7 hours. Patients gained 3 lines of vision in all lighting conditions, and distance acuity actually improved, rather than shifting myopically, Dr. Odrich said. Ocuphire Pharma Mina Sooch presented that Ocuphire is working on Nyxol (phentolamine mesylate) for refractive conditions and APX330 for retina. Nyxol has three indications: reversal of mydriasis, pres- byopia, and reduction of night vision disturbances. Nyxol relaxes the muscle to create a smaller pupil aperture and doesn't affect the ciliary muscle, Ms. Sooch said. So far, 10 clinical trials have been conducted with Nyxol, decreasing the pupil to 1–1.5 mm with durability lasting 24–36 hours. Ms. Sooch said there are two product labels being explored: Nyxol alone and Nyxol plus pilocarpine for those who need more of a presbyopia correction. Visus Therapeutics Visus is also developing a presbyopia- correcting drop. Ben Bergo described a Phase 2 safety and efficacy study that looked at three different formula- tions: BRIMOCHOL (carbachol 2.75%, brimonidine tartrate 0.1% with BAK), BRIMOCHOL PF (carbachol 2.75%, brimonidine tartrate 0.1%), and Car- bachol PF (carbachol 2.75%). All three formulations met primary and second- ary endpoints, with a high proportion gaining at least 3 lines with no myopic shift observed. Subjects, Mr. Bergo said, gained distance visual acuity in the study. The company is moving forward with preservative-free options. Editors' note: The speakers have fi- nancial interests with their respective companies. aggregation/cell clumping, and variable cell viability, Mr. Driscoll said. Preformed scaffolds are stiff/non-de- gradable, procedures are invasive, and there is poor adhesion/integration, he continued. GelMEDIX seeks to ad- dress these issues with a hydrogel that allows photocrosslinking for localiza- tion of cells. The company's focus is vision-restoring stem cell therapies and controlled release of small molecules/ peptides. Palatin Technologies Carl Spana, PhD, described how target- ing the melanocortin system could be a benefit for ocular surface disease/dry eye. Palatin Technologies is developing PL9643 to treat inflammation underly- ing the development and maintenance of dry eye. A Phase 3 clinical trial is currently enrolling, selecting patients with moderate to severe dry eye. The primary endpoints are inferior corneal staining, total conjunctival lissamine green staining, and ocular discomfort. Secondary endpoints are signs and symptoms. Dr. Spana described the trial design as innovative in that it aims to nail signs and symptoms in the same study. Refractive spotlight Allotex Allotex uses allogenic inlays to achieve presbyopia correction. David Muller said the inlays are placed under a LASIK flap and can be done at the same time as LASIK, if desired. A trial with this procedure showed 98% of patients were 20/40 or better without reading glasses or contact lenses at 6 months. Mr. Muller said patients after 3 years achieved almost 3 D of accommodation at close to 30 cm with clear corneas and no long-term adverse events. LENZ Therapeutics LENZ Therapeutics is developing a drop that uses aceclidine. Aceclidine, Marc Odrich, MD, said, has a unique mechanism of action, expanding depth of focus with action on the iris T here were several company spotlights at Eyecelerator@ ASCRS. The cornea and refrac- tive spotlights each included four companies describing their tech- nologies/therapies. Cornea spotlight Aurion Biotech Greg Kunst described Aurion as a "groundbreaking treatment" for corne- al endothelial disease. The technology manufactures corneal endothelial cells, with the cells from one donor being able to produce 100+ cell therapy treatments. These cells are then inject- ed into the eye to restore clarity and vision. "Remarkably similar results" were seen between the trials in Japan and El Salvador, despite different pa- thologies, Mr. Kunst said. The company is preparing an IND submission for the FDA and for approval in Japan later this year. Emmecell Jeffrey Goldberg, MD, PhD, said that Emmecell is developing magnetic cell technology for cell delivery, retention, and integration. The leading indication is cornea edema, but he said the com- pany is looking to expand into other areas. Magnetic cell technology, Dr. Goldberg said, presents the opportuni- ty to replace what is currently a tissue transplant procedure with an injection. Emmecell develops hundreds of doses from a single corneal button. These cells, Dr. Goldberg said, are labeled with magnetic nanoparticles. After the injection, the patient wears a magnet- ic patch for an hour. The technology is under investigation in an ongoing Phase 1B study in the U.S. GelMEDIX This early-stage biotech company is focusing on developing a proprietary hydrogel platform for cell delivery, said Arthur Driscoll. Cells for ocular therapy are currently delivered in suspension or as a preformed scaffold. Suspen- sions can have poor cell localization, Eyecelerator company spotlight: Cornea and refractive

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