The United States Food and Drug Administration (FDA) has granted approval for clobetasol propionate ophthalmic suspension 0.05% (APP13007), a collaborative effort between Taiwan-based Formosa Pharmaceuticals and AimMax Therapeutics. This groundbreaking suspension is designed for the treatment of post-operative inflammation and pain following ocular surgery, marking the first FDA-approved ophthalmic clobetasol propionate product and the first new steroid introduction to the ophthalmic market in over 15 years.
Derived from Formosa Pharma’s proprietary APNT™ nanoparticle formulation platform, clobetasol propionate ophthalmic suspension 0.05% underwent rigorous Phase 3 clinical trials, demonstrating rapid and sustained clearance of inflammation and statistically and clinically superior pain relief compared to its placebo counterpart (P < 0.001). The suspension offers a convenient and straightforward dosing regimen, involving twice-daily administration for 14 days without tapering.
Erick Co, President and CEO of Formosa Pharmaceuticals, expressed jubilation over the FDA approval, considering it a pivotal moment for the company’s global market entry and a foundation for future developments. Co extended gratitude to AimMax Therapeutics for their invaluable contributions to the program’s success and acknowledged the support from employees and colleagues. He emphasized the collaboration with Eyenovia for US commercialization, highlighting plans to expand into additional territories and advance their early-stage pipeline.
AimMax Therapeutics’ Founder and CEO, Laurene Wang, PhD, commended Formosa Pharma’s achievements, expressing pleasure in collaborating to bring this innovative formulation to the market for the benefit of millions of patients undergoing ocular surgery.
Michael Rowe, CEO of Eyenovia, expressed confidence in clobetasol propionate ophthalmic suspension 0.05%, describing it as a synergistic addition to their commercial product portfolio. Rowe anticipates a robust mid-year launch, emphasizing its potential to capture a significant share of the estimated $1.3 billion annual market opportunity due to its favorable posology and profile compared to other post-surgical steroid options.
The ophthalmic steroid market is substantial, valued at $1.3 billion, driven by the 7 million ocular surgeries performed annually in the US. Eyenovia, having acquired US commercial rights in August 2023, aims to capitalize on this market opportunity. Formosa Pharmaceuticals, entitled to significant payments and shares of common stock from Eyenovia, sees the FDA approval as a pivotal moment for the transfer of the New Drug Application (NDA) to its commercialization partner.
Additionally, Formosa Pharmaceuticals has relinquished Brazilian commercial rights to Cristália Products Químicos Farmacêuticos LTDA, securing upfront payments and milestone-related compensation upon developmental and sales achievements.
