Eyenovia | MedPath

Instil Bio's PD-L1xVEGF Bispecific Antibody Shows Promise in NSCLC, Driving 48% Stock Surge

3 days ago

• Instil Bio's stock jumped 48.4% following positive updates on IMM2510/AXN-2510, a novel PD-L1xVEGF bispecific antibody showing 23% objective response rate in relapsed/refractory non-small cell lung cancer. • The Phase 2 trial of IMM2510/AXN-2510 in first-line NSCLC in China is progressing well, with enrollment expected to complete by Q3 2025 and initial results anticipated later this year. • Instil Bio plans to expand clinical development with a U.S. Phase 1b/2 trial in solid tumors by 2025, potentially accelerating the global development pathway for this promising immunotherapy.

Pipeline Analysis Reveals 20+ Therapies in Development for Open-Angle Glaucoma Treatment

a month ago

• DelveInsight's latest report identifies 18+ companies developing 20+ therapeutic candidates for open-angle glaucoma, with several treatments advancing through late-stage clinical trials. • Key players including Nicox, Qlaris Bio, and Glaukos Corporation are making significant progress with innovative treatments like NCX 470, QLS-111, and iDose TREX, demonstrating positive clinical outcomes. • Novel drug delivery mechanisms, including sustained-release implants and encapsulated cell therapies, are emerging as promising approaches to address the challenges of treatment adherence and efficacy in glaucoma management.

Formosa Pharmaceuticals and Cipla Form Strategic Partnership for APP13007 Commercialization Across 11 Countries

2 months ago

• Formosa Pharmaceuticals has granted Cipla Limited exclusive rights to market clobetasol propionate ophthalmic suspension 0.05% (APP13007) across 11 countries in Asia, Africa, and South America. • APP13007, FDA-approved in March 2024, offers a simplified twice-daily dosing regimen for 14 days without tapering for post-operative inflammation and pain following ocular surgery. • This agreement represents Cipla's first multi-regional licensing agreement in ophthalmology and includes upfront payments, royalty milestones, and additional value-driven considerations.

Eyenovia and Betaliq Plan Reverse Merger to Create Innovative Ophthalmic Technology Company

2 months ago

• Eyenovia has entered into a non-binding letter of intent with Betaliq to create a new publicly-listed eye care company valued at approximately $92 million, with Betaliq shareholders owning 83.7% of the combined entity. • The merger would combine Betaliq's EyeSol® water-free drug delivery technology for glaucoma with Eyenovia's Optejet® device platform, potentially creating a revolutionary approach to topical eye medication administration. • If completed, the combined company would continue marketing Eyenovia's FDA-approved products while developing new treatment options for glaucoma and other ocular diseases through established partnerships.

Gilead's Trodelvy Receives FDA Breakthrough Therapy Designation for SCLC; Seladelpar Recommended for EU Approval

5 months ago

• The FDA granted Breakthrough Therapy Designation to Gilead's Trodelvy for extensive-stage small cell lung cancer (ES-SCLC) after platinum-based chemotherapy, based on promising results from the TROPiCS-03 study. • Gilead will collaborate with Terray Therapeutics to discover and develop novel, small molecule therapies across multiple targets, leveraging Terray's tNova platform. • The European Medicines Agency's CHMP recommended approval of Gilead's seladelpar for primary biliary cholangitis (PBC) in combination with UDCA or as monotherapy.

Advancements in Clinical Trials for Fabry Disease, C. difficile Infections, and Mydriasis

6 months ago

• Clinical trials are actively progressing for Fabry Disease, with companies like Idorsia and Sanofi Genzyme developing novel therapies. • Emerging treatments like Venglustat and Pegunigalsidase alfa are expected to significantly impact the Fabry Disease market in the coming years. • Research and development efforts are also focused on Clostridium Difficile Infections, with Vedanta Biosciences leading Phase 3 trials for VE303. • Mydriasis treatments are advancing, with companies like Eyenovia exploring solutions like MYDCOMBI for pupil dilation.

Eyenovia's Stock Plummets After Phase III Myopia Trial Fails to Meet Primary Endpoint

6 months ago

• Eyenovia's stock price plummeted after its Phase III CHAPERONE study, evaluating a drug-device combination for pediatric progressive myopia, failed to meet its primary endpoint. • The CHAPERONE trial assessed low-dose atropine delivered via the Optejet platform but did not demonstrate a statistically significant difference in myopia progression compared to the comparator arm. • Eyenovia is terminating the CHAPERONE study and considering strategic options, including potential business combinations or asset sales, to preserve company value. • Despite this setback, other companies like Vyluma and Johnson & Johnson Vision have recently reported positive data and received FDA approval in the myopia treatment space.

Eyenovia's Myopia Trial Fails, Stock Plummets

6 months ago

• Eyenovia's stock price plummeted after its Phase III CHAPERONE study for pediatric progressive myopia failed to meet the primary endpoint. • The CHAPERONE trial assessed a low-dose atropine formulation delivered via the Optejet platform but did not demonstrate a significant difference in myopia progression compared to the comparator. • Eyenovia plans to terminate the CHAPERONE study and is considering strategic options, including potential business combinations or asset sales, to preserve company value. • Despite the trial failure, Eyenovia reported that all dosages and the placebo were well-tolerated, with only mild and infrequent adverse events observed.

Eyenovia's Phase 3 CHAPERONE Study Fails to Meet Primary Endpoint in Pediatric Myopia

6 months ago

• Eyenovia's Phase 3 CHAPERONE study, evaluating low-dose atropine via Optejet for pediatric myopia, did not meet its primary endpoint of less than 0.5 diopter progression over three years. • An independent Data Review Committee found no significant difference in myopia progression between the atropine treatment arms (0.01% and 0.1%) and the placebo group. • The company plans to discontinue the CHAPERONE study, conduct a thorough data review, and assess future steps for the myopia program. • Eyenovia is considering strategic options, including potential business combinations or asset sales, to maximize stakeholder value.

Eyenovia Halts Phase III Myopia Trial, Explores Strategic Alternatives

6 months ago

• Eyenovia discontinues its Phase III clinical trial for a drug-device combination product aimed at treating pediatric myopia after an unfavorable assessment by the data monitoring committee. • The committee determined that the trial was unlikely to meet its primary endpoint, leading Eyenovia to cease the study and re-evaluate its strategic direction. • This decision prompts Eyenovia to consider various strategic options, including potential partnerships or a shift in focus, following the termination of the myopia study. • The setback highlights the challenges in developing effective treatments for pediatric myopia and the importance of adaptive trial designs in pharmaceutical research.

Eyenovia's Stock Plummets After Phase III Myopia Study Fails

6 months ago

• Eyenovia discontinued its Phase III CHAPERONE study for MicroPine, a low-dose atropine treatment for pediatric progressive myopia, after it failed to meet the primary endpoint. • An independent Data Review Committee found no significant difference in myopia progression between the treatment arms and placebo in the study of 252 patients. • Eyenovia's stock price dropped approximately 70% following the announcement, leading to a downgrade from William Blair due to capital constraints. • Despite the setback, Eyenovia will focus on its two marketed products, including clobetasol propionate ophthalmic solution 0.05% for post-operative inflammation.

Eyenovia's Phase 3 CHAPERONE Study Fails to Meet Primary Endpoint in Pediatric Myopia

6 months ago

• Eyenovia's Phase 3 CHAPERONE study, evaluating low-dose atropine for pediatric progressive myopia, did not meet its primary endpoint. • The Data Review Committee found no significant difference in myopia progression between atropine (0.01% and 0.1%) and placebo groups. • Eyenovia plans to terminate the CHAPERONE study and is considering strategic options, including a potential business combination or asset sales. • Safety analysis indicated that all dosages of atropine were well-tolerated, with a mild adverse event profile observed during the study.

Eyenovia's Phase 3 CHAPERONE Study Fails to Meet Primary Endpoint for Pediatric Myopia

6 months ago

• Eyenovia's CHAPERONE Phase 3 trial, evaluating low-dose atropine via Optejet for pediatric myopia, did not meet its primary endpoint of slowing myopia progression over three years. • An independent Data Review Committee found no significant difference in myopia progression between the active treatment arms (0.01% and 0.1% atropine) and placebo. • Eyenovia plans to discontinue the CHAPERONE study, conduct a thorough data review, and assess strategic options, including potential business combinations or asset sales. • The company reports that all dosages and placebo were well-tolerated, with a mild adverse event profile observed during the study.

Eyenovia Reports Q3 2024 Results: Clobetasol Launch and Myopia Program Advance

6 months ago

• Eyenovia launched clobetasol propionate ophthalmic suspension 0.05% in the U.S. for post-operative inflammation, marking the first new ocular steroid in over 15 years. • The company is advancing its Phase 3 CHAPERONE study for MicroPine in pediatric myopia, with an interim analysis expected this quarter. • Mydcombi's reach expanded to 230 new offices between April and September 2024, demonstrating steady market penetration. • Eyenovia reported a net loss of $7.9 million for Q3 2024, with operating expenses increasing by 10.6% to $7.2 million.

AAO 2024: Emerging Data in Retinal Therapies for Geographic Atrophy, Stargardt Disease, and Retinitis Pigmentosa

7 months ago

• Alkeus Pharmaceuticals will present results from clinical studies of oral gildeuretinol for geographic atrophy secondary to age-related macular degeneration (SAGA) and Stargardt disease (TEASE). • Annexon will share new analyses of ANX007 from the Phase 2 ARCHER trial in geographic atrophy, highlighting clinical results and anatomical changes. • Nanoscope Therapeutics is set to share topline data from the RESTORE trial of MCO-010 therapy in patients with severe vision loss due to retinitis pigmentosa (RP).

Eyenovia Launches Clobetasol Propionate Ophthalmic Suspension for Post-Ocular Surgery Inflammation and Pain

8 months ago

• Eyenovia has commercially launched clobetasol propionate ophthalmic suspension 0.05% in the U.S. for treating post-operative inflammation and pain after eye surgery. • Clobetasol, a potent steroid, offers a convenient twice-daily dosing regimen, distinguishing it from many other post-surgical eye drops. • Phase 3 study results presented at AAO 2024 demonstrated rapid inflammation and pain relief with clobetasol compared to placebo, along with improved visual acuity. • Market research indicates strong interest from ophthalmic surgeons in prescribing clobetasol due to its efficacy, safety profile, and simplified distribution model.