Clobetasol propionate ophthalmic suspension 0.05% approved for postop inflammation, pain
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Key takeaways:
- Clobetasol propionate ophthalmic suspension 0.05% was approved to treat inflammation and pain after ocular surgery.
- Eyenovia plans to launch the eye drop in the U.S. later this year.
The FDA approved clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain after ocular surgery, according to a press release from Formosa Pharmaceuticals and AimMax Therapeutics.
“We believe ophthalmologists will be enthusiastic at having a new tool (first new steroid in the indication in more than 15 years) to address the aftereffects of ocular surgery,” Erick Co, president and CEO of Formosa, told Healio. “Through a commissioned [key opinion leader] survey, we observed that the dosing regimen (twice daily for 14 days) provided the most compelling value proposition, as it differentiates from the standards of care.”
Clobetasol propionate ophthalmic suspension 0.05% (APP13007) demonstrated “rapid and sustained clearance of inflammation and pain relief” in two phase 3 clinical trials in which it showed statistical and clinical superiority to placebo (P < .001).
“The clinical data suggest that ophthalmologists may have confidence in delivering rapid and sustained inflammation and pain clearance with lesser concern for side effects that often accompany the more potent therapies,” Co said.
The formulation is the first ophthalmic clobetasol propionate product to receive FDA approval and the first new steroid to enter the ophthalmic market in more than 15 years, the release said.
Eyenovia acquired the U.S. commercial rights to APP13007 in August 2023 and plans to launch the eye drop in the U.S. market “as soon as this summer,” with longer-term plans including the development of the product as a potential treatment for dry eye disease.
“The immediate goal is working closely with our established commercialization partners toward launch while expanding our reach into new territories,” Co said. “Furthermore, we are actively exploring additional ophthalmic and non-ophthalmic indications with APP13007, leveraging clobetasol propionate’s unique anti-inflammatory potency and profile.”
Reference:
- 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. 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/. Published March 5, 2024. Accessed March 5, 2024.
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