Byqlovi (clobetasol propionate ophthalmic suspension) / Formosa Labs, AimMax Therap, Harrow Health - LARVOL DELTA

Harrow Acquires U.S. Commercial Rights to BYQLOVI (Clobetasol Propionate Ophthalmic Suspension) 0.05% from Formosa Pharmaceuticals (Businesswire) - "Harrow...and Taiwan-based Formosa Pharmaceuticals...announced a licensing agreement, whereby Harrow has acquired the exclusive U.S. commercial rights for BYQLOVI (clobetasol propionate ophthalmic suspension) 0.05%. BYQLOVI was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of post-operative inflammation and pain following ocular surgery and is the first new ophthalmic steroid in its class in over 15 years. Harrow expects BYQLOVI to be available in the fourth quarter of 2025."

Commercial • Launch US • Inflammation • Ocular Inflammation • Pain

Apotex announces expansion of licensing agreement with Formosa Pharmaceuticals to Mexico for commercialization of clobetasol propionate ophthalmic suspension for the treatment of inflammation and pain following ocular surgery (Yahoo Finance) - "Apotex...announced it has entered into an exclusive licensing agreement with Formosa Pharmaceuticals...for exclusive rights in Mexico for the commercialization of clobetasol propionate ophthalmic suspension, 0.05% (APP13007), a patented innovative medicine for the treatment of inflammation and pain following ocular surgery, upon regulatory approval....APP13007 was approved by the U.S. Food and Drug Administration (FDA) in 2024. APP13007's active ingredient is the corticosteroid clobetasol propionate, and it is derived from Formosa Pharma's proprietary APNT nanoparticle formulation platform....This license agreement for the Mexican market adds to Apotex's existing exclusive rights to this product in Canada."

Licensing / partnership • Inflammation • Ocular Inflammation • Pain

Eyenovia Announces Presentation of Phase 3 Clobetasol Study Results at the American Academy of Ophthalmology (AAO) 2024 Expo (GlobeNewswire) - "Eyenovia, Inc...announced a presentation at the American Academy of Ophthalmology (AAO) 2024 Expo, which is being held October 19-21, in Chicago. The presentation will detail the results of a successful Phase 3 study (CPN-302) of clobetasol propionate suspension 0.05% (APP13007) that led to its approval by the U.S. Food and Drug Administration as a treatment for inflammation and pain following ocular surgery."

P3 data • Ophthalmology • Pain

Clobetasol Propionate Ophthalmic Suspension 0.05% (APP 13007) for the Treatment of Postsurgical Inflammation and Pain (Study CPN-302) (AAO 2024) - "Mean IOP changes were similar between groups, and there were no difference in the other observed safety measures, including corneal endothelial cell count. Conclusion APP13007 produced prompt and marked reduction of ocular inflammation and pain, more rapid improvement VA and a safety profile similar to placebo."

Cataract • Ocular Inflammation • Ophthalmology

Evaluation of APNT™ Nanoparticle Formulation in Ophthalmic Medications (ARVO 2024) - "In vivo studies assessed investigational ophthalmic agents utilizing APNT in a potent corticosteroid, APP13007 (API-1) clobetasol propionate, and a known macrolide antibiotic (API-2)... APNT nanoparticle technology affords improved delivery of poorly soluble medications and limited bioavailability. Drug penetration and residence time were enhanced by APNT in these in vivo studies with the potential to improve dissolution and distribution within ocular tissues. In the case of API-1, phase 3 trials have been conducted (presented at ASCRS 2023) for the treatment of pain and inflammation post-ocular surgery and showed promising results using APNT in humans."

Ocular Inflammation • Ophthalmology • Retinal Disorders

The FDA has approved clobetasol propionate ophthalmic suspension 0.05% (APP 13007) by Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics (Medthority) - "This suspension for the treatment of post-operative inflammation and pain following ocular surgery is the first FDA-approved ophthalmic clobetasol propionate product and first new steroid on the US ophthalmic market in over 15 years."

NDA • Ocular Inflammation • Ophthalmology • Pain

Sosei Heptares to receive US$2.5 million milestone payment from Formosa Pharmaceuticals (GlobeNewswire) - "Sosei Group Corporation...announces that Formosa Pharmaceuticals, Inc. ('Formosa') has received approval from the US Food & Drug Administration ('FDA') for clobetasol propionate ophthalmic suspension 0.05% (APP13007), for the treatment of post-operative inflammation and pain following ocular surgery. The milestone has triggered a US$2.5 million payment to Sosei Heptares from Formosa....Under the terms of the sale to Formosa in 2017, Sosei Heptares is entitled to receive undisclosed milestone payments based on progression of Activus’ pipeline as well as royalties from the commercialization of certain products should they reach the market."

Financing • Ocular Inflammation • Ophthalmology • Pain

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study (clinicaltrials.gov) - P3 | N=370 | Completed | Sponsor: Formosa Pharmaceuticals, Inc. | Recruiting ➔ Completed

Surgery • Trial completion • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain

A Phase 3 Study of APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension 0.05%) to Treat Inflammation and Pain after Cataract Surgery (ASCRS-ASOA 2023) - "Purpose To evaluate the efficacy and safety of APP13007 (APP) twice daily (BID) in a Phase 3 double-masked, placebo-controlled study of subjects with inflammation on the first post-operative day (POD1) following routine, uncomplicated cataract surgery.MethodsEligible subjects were randomized on POD1 to receive 1 drop of APP or placebo (PBO) BID in the study eye for 14 days (APP N=181; PBO N=197).Primary efficacy endpoints: (i) % of subjects with anterior chamber cell (ACC) count=0 at POD8 maintained through POD15, and (ii) % of subjects with ocular pain grade=0 at POD4 maintained through POD15.Secondary endpoints included % of subjects with ACC count=0 and pain grade=0 at PODs 4, 8, 15 and visual acuity (VA).Safety evaluations included adverse events (AE), intraocular pressure (IOP), ophthalmoscopy and VA.Demographics were well balanced between groups (overall mean age 68.3 yrs, 59.5% females and 79.6% white).ResultsBoth primary efficacy objectives were achieved in favor..."

P3 data • Surgery • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Pain

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery (clinicaltrials.gov) - P3 | N=378 | Completed | Sponsor: Formosa Pharmaceuticals, Inc. | Recruiting ➔ Completed

Trial completion • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pain

APP13007 (Clobetasol Propionate Ophthalmic Nanosuspension) for the Treatment of Inflammation and Pain after Cataract Surgery (ARVO 2022) - "These data support the development of APP13007 0.05% BID to treat inflammation and pain following ocular surgery."

Cataract • Ocular Inflammation • Ophthalmology

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study (clinicaltrials.gov) - P3 | N=370 | Recruiting | Sponsor: Formosa Pharmaceuticals, Inc. | Trial completion date: Feb 2022 ➔ Jun 2022 | Trial primary completion date: Feb 2022 ➔ Jun 2022

Trial completion date • Trial primary completion date • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pain

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery (clinicaltrials.gov) - P3 | N=370 | Recruiting | Sponsor: Formosa Pharmaceuticals, Inc. | Trial completion date: Dec 2021 ➔ Mar 2022 | Trial primary completion date: Dec 2021 ➔ Mar 2022

Trial completion date • Trial primary completion date • Cataract • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pain