Clobetasol propionate ophthalmic suspension 0.05% (APP13007) for the treatment of post-operative pain and inflammation following ocular surgery has been approved by the FDA, Formosa Pharmaceuticals and AimMax Therapeutics announced in a release.1 The approval makes APP13007 the first ophthalmic clobetasol propionate product approved by the FDA and is the first new ophthalmic steroid on the market in over 15 years.
The approval was based on 2 randomized, double-masked, phase 3 clinical trials, CPN-301 (NCT04739709) and CPN-302 (NCT04810962), which showed that APP13007 demonstrated statistically significant clearance of both inflammation and pain relief following cataract surgery compared to placebo. The eyedrops utilize a potent corticosteroid that’s derived from a proprietary nanoparticle formulation from Formosa, called APNT.
Key Takeaways
- Clobetasol propionate ophthalmic suspension 0.05% (APP13007) from Formosa Pharmaceuticals and AimMax Therapeutics received FDA approval for post-operative pain and inflammation after ocular surgery.
- APP13007 demonstrated in 2 phase 3 trials that it significantly clears inflammation and relieves pain following cataract surgery compared to a placebo, and demonstrated a well-tolerated safety profile.
- Eyenovia, holding US commercial rights, plans to launch mid-year, targeting ophthalmologists and ocular surgery patients. Formosa Pharmaceuticals looks forward to further development and expansion into additional territories.
“This approval marks Formosa Pharma’s entry into the global marketplace and provides a critical foundation and momentum for continued development, as well as advancement of new endeavors,” Erick Co, president and CEO of Formosa Pharmaceuticals, said in a release.1 “With immense gratitude, we thank our development colleagues at AimMax Therapeutics for their wisdom and tenacity in guiding the program through to success. Equally, we recognize the tireless efforts of our employees and unwavering support from colleagues in the realization of this corporate milestone.”
The 2 phase 3 studies included nearly 750 participants who had cataract surgery across several different sites in the United States. The participants were assigned to receive either 1 drop of clobetasol propionate ophthalmic suspension 0.05% twice daily for 14 days or placebo. Primary endpoints included the complete and sustained resolution of ocular inflammation and pain after cataract surgery.
The study found that 26.5% of patients who received APP13007 had no inflammation cells from day 8 through day 15 after surgery, compared to 6.8% in placebo. Additionally, 71.6% of patients who received the treatment had no pain day 4 through day 15 after surgery, compared to 27.7% in placebo. The study also showed that the treatment was well tolerated and had a safety profile similar to placebo.2
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The US commercial rights for APP13007 were acquired in August 2023 by the commercial-stage ophthalmic company Eyenovia. The company said that it is also exploring further development of APP13007 as a potential treatment for dry eye.
“We congratulate Formosa Pharmaceuticals on the FDA approval of clobetasol propionate ophthalmic suspension 0.05%, the first approved therapeutic to leverage its APNT formulation platform, and the first new ophthalmic steroid to enter the US market in over 15 years,” Michael Rowe, CEO of Eyenovia, said in a release.3 “The efficacy profile of clobetasol propionate ophthalmic suspension 0.05% is highly desirable, and adverse events were seen in no more than 2% of patients; many of the adverse events may have been caused by the surgical procedure itself. Moreover, we believe its efficacy, safety, and convenient dosing regimen…will resonate with patients and eye doctors alike…”
The novel clobetasol propionate ophthalmic suspension 0.05% eyedrops are entering a topical ophthalmic steroids and steroid combination market that is worth around $1.3 billion, driven largely by the 7 million ocular surgeries performed every year in the US. Eyenovia said it plans to launch the new product mid-year.
“With FDA approval now secured, we look forward to working with our US commercialization partner, Eyenovia, to reach ophthalmologists and ocular surgery patients, while in parallel working to expand into additional territories and advance our earlier stage pipeline,” said Co.
READ MORE: Eye Health Resource Center
References
3. 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. News Release. Eyenovia. March 5, 2024. Accessed March 5, 2024. https://ir.eyenovia.com/news-releases/news-release-details/eyenovia-congratulates-formosa-pharmaceuticals-fda-approval
