Eyeworld Daily News

JULY 24, 2021 | EYEWORLD DAILY NEWS | 3 ASCRS ANNUAL MEETING DAILY NEWS showing 47% of participants gained 3 or more lines in NVA and 92% gained 2 or more lines at 1 hour with a 2 or more line improvement; • Visus Therapeutics with a fixed combination of carbachol/bri- monidine tartrate; • Kedalion Therapeutics with AcuStream, currently research- ing 1% or 2% pilocarpine in Phase 2 trial; and • OSRX with EyeFocus-01, an investigative product miotic, alpha-1 agonist, H1 antagonist, and NSAID. She also discussed companies working on lens softening agents, like Novartis with a lipoic acid choline ester chloride designed to act on disulfide bonds between crystalline lens proteins. Dr. McDonald closed talking about LIRIC (laser-induced refractive index change). This investigational treatment is pro- duced by a femtosecond laser to non-invasively alter the refractive index of the cornea. She described it as a minimally invasive treat- ment with almost no effect on corneal nerves that wouldn't need antibiotics or steroids. She said this technology could also be used to induce multifocality on mono- vision IOLs (or vice versa) and in contact lens technology. In summary, Dr. McDonald said there are several options to treat presbyopia in the U.S. but many of the best new treatments (Opti-K, LIRIC, and pharmaco- logic agents) are working toward FDA approval. Editors' note: Dr. McDonald has financial interests with several ophthalmic companies. surgery. Multifocal glasses, Dr. McDonald described, are associat- ed with an increased risk of falls. In elderly patients, she continued, more than one in three falls can be attributed to multifocal glasses. Contact lenses for presbyopia are underutilized, among contact lens wearers, and have a low retention rate. Dr. McDonald pre- sented data that showed only 46% of presbyopic contact lens wearers are offered multifocal or mono- vision options, and research has shown only about 50% retention for patients who have tried these types of contact lenses. Surgical solutions like mono- vision LASIK, SMILE, and PRK have achieved some popularity, especially among former con- tact lens wearers who have tried monovision, Dr. McDonald said. But she noted some of the draw- backs to monovision include its association with a decrease in intermediate and mesopic visual acuity and its effect on contrast sensitivity and stereoacuity. PresbyLASIK, she said, has not yet become popular due to the induction of blur from increased aberrations with loss of contrast sensitivity. Dr. McDonald noted that subsequent modifications to the technique claim to overcome these limitations. Dr. McDonald also described laser thermokeratoplasty and conductive keratoplasty, both of which are FDA approved, but neither have achieved widespread adoption. Optimal keratoplasty (Opti-K), which has the CE mark, uses an infrared thulium fiber laser-based system; it is in clinical trials for hyperopia and mono- vision treatments in the U.S. Dr. McDonald described Opti-K as a non-invasive, rapid procedure with minimal discomfort and downtime. She said it is safely re- peatable, as needed, because the treatment regresses completely over 1–2 years. Next, Dr. McDonald moved into what's on the horizon, first addressing the multitude of pres- byopia-correcting drops in clinical trials. Many of these work with pupil-constricting agents, such as pilocarpine. She noted that pilocarpine in these trials is much lower than what was used in glau- coma and is being delivered with sophisticated vehicles. Allergan's AGN-190584 pilo- carpine agent has completed two Phase 3 clinical trials, showing more patients in the treatment group compared to control gain- ing 3 or more lines of mesopic, high-contrast, binocular DCNVA at 3 hours without impact on distance vision. Allergan has sub- mitted an NDA to the FDA with an anticipated decision by late 2021. Other companies studying pupil constricting agents that Dr. McDonald covered included: • Orasis with CSF-1, which completed a Phase 2 study that showed 3 or more lines of DCNVA gained with twice daily dosing; • Eyenovia with MicroLine that completed a Phase 3 trial that showed a 3 or more line im- provement in DCNVA compared to control after 2 hours with a second Phase 2 study underway; • Ocuphire with a pilocarpine and phentolamine agent designed to be dosed in the evening for a 24-hour effect; • LENZ Therapeutics with acecli- dine paired with tropicamide that has a Phase 2 study, continued from page 1

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