Eyeworld Daily News

20 | EYEWORLD DAILY NEWS | JULY 23, 2021 ASCRS ANNUAL MEETING DAILY NEWS P resbyopia was a primary topic of discussion on the Eyecelerator program. Moderator John Berdahl, MD, and panelists Preeya Gupta, MD, John Hovanesian, MD, Gil Kliman, MD, and Vance Thompson, MD, led the session, which featured company presen- tations on presbyopia drops in development. Michael Robinson, MD, presented from Allergan on the company's AGN-190584. He stressed the product's optimized formulation with pHast tech- nology, which rapidly adjusts to neutral pH after administration and leads to improved bioavail- ability and tolerability. This product, he said, was identified after rigorously testing 16 differ- ent formulations of computational modeling to find the optimized concentration of pilocarpine that maximizes efficacy and safety. When asked about what he thinks Allergan's responsibility is in this presbyopia-treatment category, Dr. Robinson said that a solid formulation, efficacy data, and safety are important. Michael Rowe, shared infor- mation on Eyenovia's MicroLine product, delivered using the Optejet dispenser, saying that the company is trying to make it easier and more tolerable for patients with drops. Standard eyedroppers have limited thera- peutic approaches, he said, with the potential for overexposure. The MicroLine product profile, he said, shows that it's effective at restoring functional vision; has New presbyopia drops a highlight at Eyecelerator session an ability to be used "as needed" without chronic dosing; has a rapid onset of action; is easy to administer; and has a low in- stance of side effects. He mentioned the company's VISION-1 study, which achieved its primary endpoint in Phase 3 of a statistically significant propor- tion of subjects in the treatment arm achieving a three-line or more improvement in distance- corrected near visual acuity. Mina Sooch discussed Ocuphire Pharma's Nyxol (phen- tolamine ophthalmic solution), which has three different indica- tions for presbyopia, night vision disturbances, and reversal of mydriasis. Nyxol works on the iris dilator muscle and creates a moderate miotic. It has 24-hour durability and was well tolerated in clinical studies, she said, adding that it's preservative free and stable. The product is combined with low- dose pilocarpine. She noted that results from the VEGA-1 Phase 2 trial were good, meeting primary and secondary endpoints, and the company expects to move to a Phase 3 program next year and to file an NDA in 2023. Elad Kedar presented on behalf of Orasis Pharmaceutical, noting that efficacy, safety, and comfort need to be balanced in the optimal presbyopia-correcting solution. Orasis' winning com- bination was low-concentration pilocarpine and a proprietary multifaceted vehicle, seeking exceptional near visual acuity, no reduction of distance vision and night vision, a high safety and tolerability profile, improved com- fort, and being preservative free. Mr. Kedar mentioned re- sults from a Phase 2b study that showed no negative impact on distance or night vision. The com- pany is now running a Phase 3 study, NEAR-1 and NEAR-2, which are expected to be completed later this year. Eef Schimmelpennink presented on LENZ Thera- peutics' product, which is an aceclidine-based eye drop to treat presbyopia, with two key mecha- nisms for miotics: triggering the iris sphincter and avoiding over- stimulation of the ciliary muscle. He noted successful Phase 2 results, including rapid onset (after 30 minutes) and a long du- ration (7 hours). Research showed that aceclidine targets the iris sphincter without overstimulating the ciliary muscle, he said, adding that LENZ has the first and only aceclidine-based eye drop, with a promise of seamless vision for the vast majority of all presbyopes. Ben Bergo shared information on the BRIMOCHOL product from Visus Therapeutics, which has been studied in six clinical trials and more than 200 patients. It achieved clinical efficacy out- comes including significant near visual acuity improvement for 8–12 hours past dose (studied in both emmetropic presbyopia and presbyopic pseudophakes), no impact on distance vision, and no impact on IOP.

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