Tropicamide

DelveInsight's 'Mydriasis Pipeline Insight, 2024' report details the global Mydriasis pipeline, featuring 3+ key companies developing 3+ therapies. Insights include clinical trials, mechanism of action, route of administration, and emerging therapies like RYZUMVI, MYDCOMBI, and OMIDRIA. The report covers pre-clinical to marketed phases, highlighting active and inactive projects, collaborations, and market dynamics.

Eyenovia's stock dropped to under 10 cents after discontinuing a Phase III pediatric myopia study, as its drug-device combo MicroPine failed to meet primary endpoints. The company has two marketed products, including clobetasol propionate eye drops for post-operative inflammation, and MydCombi for mydriasis.

Eyenovia's CHAPERONE Phase 3 study fails to meet primary endpoint of less than 0.5 diopter progression in visual acuity over three years. The independent Data Review Committee found no significant difference in myopia progression between treatment arms and placebo. Eyenovia plans to discontinue the study, review data, and evaluate next steps.

Eyenovia reported Q3 2024 net loss of $7.9 million ($0.11 per share), with operating expenses up 10.6% to $7.2 million. Key developments include U.S. launch of clobetasol propionate ophthalmic suspension 0.05%, Phase 3 CHAPERONE study for MicroPine in pediatric myopia, and Mydcombi registration batches in second-generation Optejet device. Cash position was $7.2 million, with $10.7 million raised in net proceeds. Mydcombi expanded to 230 new offices from April to September 2024.

Eyenovia announced its clobetasol propionate suspension 0.05% (APP13007) presentation at the AAO 2024 Expo, detailing a successful Phase 3 study (CPN-302) leading to FDA approval for post-surgical inflammation and pain treatment. Clobetasol is now commercially available.

Ocuphire Pharma's Phase 3 trials (MIRA-2 and MIRA-3) showed phentolamine ophthalmic solution 0.75% (Ryzumvi) rapidly and effectively reverses pharmacologically-induced mydriasis with a favorable safety profile, published in *Ophthalmology*. FDA-approved Ryzumvi, a preservative-free eye drop, significantly reversed mydriasis at 90 minutes compared to placebo, with effects observed as early as 60 minutes. The solution demonstrated a favorable safety profile, with mild and transient adverse events.

Ocuphire Pharma announced results from 2 Phase 3 trials (MIRA-2 and MIRA-3) showing phentolamine ophthalmic solution 0.75% (Ryzumvi) effectively reversed pharmacologically-induced mydriasis with a favorable safety profile. Published in *Ophthalmology*, the trials demonstrated a statistically significant reversal at 90 minutes compared to placebo, with rapid onset and significant improvements in pupil diameter up to 24 hours. The solution, approved by the FDA, is marketed for treating mydriasis caused by adrenergic agonists or parasympatholytic agents.

Ocuphire Pharma announced the publication of Phase 3 trial results for RYZUMVI™ (Phentolamine Ophthalmic Solution 0.75%) in Ophthalmology, demonstrating its efficacy and safety in reversing pharmacologically-induced mydriasis.

Eyenovia, Inc. announces the U.S. launch of clobetasol propionate ophthalmic suspension 0.05%, approved by the FDA for post-operative inflammation and pain following ocular surgery. The product, the first new ophthalmic steroid in over 15 years, is expected to generate strong interest among eye doctors due to its efficacy, safety profile, and streamlined distribution.