After Formosa snags FDA nod for reformulation of old steroid, partner Eyenovia plots launch

Taiwan’s Formosa Pharmaceuticals has gained an FDA approval for a reformulation of a decades-old corticosteroid. 

Monday, the U.S. FDA granted approval to Formosa and AimMax Therapeutics’ clobetasol propionate ophthalmic suspension 0.05% to treat post-operative inflammation and pain following eye surgery.

The drug utilizes a potent corticosteroid modified with Formosa’s APNT nanoparticle formulation platform, which makes it possible to administer to the eye via a twice-daily dosing regimen, the companies said in a release.

Clobestasol propionate is a prednisolone derivative that snared its first FDA approval on Dec. 27, 1985. As a topical steroid, the drug is used to treat multiple skin conditions such as eczema, psoriasis, allergies and rash.

The FDA based its recent approval on two phase 3 trials, in which Formosa’s nanosuspension steroid provided “rapid and sustained” clearance of inflammation and pain relief after eye surgery versus placebo, the company explained in its release.

Formosa’s eye-drop is set to enter a $1.3 billion market for topical ophthalmic steroids, the company said.

In order to breach the market, Formosa has tapped commercial stage eyecare specialist Eyenovia in the U.S. In a separate release, Eyenovia said it plans to launch in the U.S. “as soon as this summer,” leveraging the same salesforce it uses to market its pupillary dilation spray Mydcombi.

Mydcombi, a fixed-dose combination of two popular dilating meds tropicamide and phenylephrine, was approved in May of 2023. The drug represents the first approved product made with Eyenovia’s Optejet device system.

Unlike traditional eye droppers where patients need to tilt their heads and fight the urge to avoid a droplet, Optejet dispenses its drug in microdoses horizontally as a spray with the push of a button.

As for the newly approved steroid nanosuspension, Eyenovia picked up the U.S. commercial rights to Formosa’s product last August.

The eyecare specialist paid $2 million upfront to Formosa, split evenly between cash and stock, and also pledged up to $4 million in development milestones and $80 million in sales milestones, according to a recent securities filing.

Besides marketing Formosa’s drug, Eyenovia is exploring further development of the clobetasol propionate formulation in its Optejet dispenser as a potential treatment for dry eye.

Elsewhere, Formosa has been busy striking separate commercialization pacts in other countries, too.

In late January, the company enlisted Cristália Produtos Químicos Farmacêuticos to help bring the product to the Brazilian market.