FDA Approves First New Ophthalmic Steroid in 15 Years: Clobetasol Propionate Ophthalmic Suspension 0.05% (APP13007) for Post-Surgical Inflammation and Pain

Mar 06, 2024 07:30 CST Updated 07:31

Formosa

Biopharmaceutical Manufacturer

AimMax Therapeutics

Biopharmaceutical R&D Developer

▎WuXiEdited by Kant Content Team

Recently, Formosa Pharmaceuticals and AimMax Therapeutics announced that the U.S. FDA has approved the listing of 0.05% clobetasol propionate ophthalmic suspension (APP13007) for the treatment of inflammation and pain following ophthalmic surgery. The press release noted that this isThe first clobetasol propionate ophthalmic product approved by the FDA, and the first novel steroid therapy in the ophthalmology market in 15 years, offering patients a convenient and direct drug delivery option.

Clobetasol Propionate Ophthalmic Suspension utilizes a superpotent corticosteroid, manufactured based on Formosa Pharmaceuticals' proprietary APNT nanoparticle formulation platform.The FDA approval was based on two Phase 3 clinical trials, which demonstrated rapid and sustained inflammation resolution and pain relief effects that were statistically and clinically superior to placebo (p<0.001).Nearly 90% of patients experience no pain at all after the surgery, and approximately 60% of patients have no inflammatory response within 15 days following ophthalmic surgery.

Grand Pharmaceutical Group holds the exclusive rights for the development and commercialization of this therapy in mainland China, Hong Kong, and Macao. In China, it was approved in April 2023 to conduct a Phase 3 clinical trial. This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial, planning to enroll 252 patients undergoing cataract surgery, aiming to evaluate its efficacy and safety in treating inflammation and pain following cataract surgery.

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References:

[1] Formosa Pharmaceuticals And AimMax Therapeutics Receive FDA Approval For Clobetasol Propionate Ophthalmic Suspension 0.05%, For The Treatment Of Post-Operative Inflammation And Pain Following Ocular Surgery. Retrieved March 5, 2024, from https://www.formosapharma.com/formosa-pharmaceuticals-and-aimmax-therapeutics-receive-fda-approval-for-clobetasol-propionate-ophthalmic-suspension-0-05-for-the-treatment-of-post-operative-inflammation-and-pain-following-ocular-su/

[2] Eyenovia Congratulates Formosa Pharmaceuticals on FDA Approval of Clobetasol Propionate Ophthalmic Suspension 0.05% for the Treatment of Post-operative Inflammation and Pain Following Ocular Surgery. Retrieved March 5, 2024, from https://eyenovia.com/eyenovia-congratulates-formosa-pharmaceuticals-on-fda-approval-of-clobetasol-propionate-ophthalmic-suspension-0-05-for-the-treatment-of-post-operative-inflammation-and-pain-following-ocular-surgery/

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