FDA Approves First-in-Class Clobetasol Propionate Ophthalmic Suspension (APP13007) for Postoperative Ocular Inflammation and Pain

Recently, Formosa Pharmaceuticals (referred to as "Formosa") and AimMax Therapeutics announced that the FDA has approved the listing of clobetasol propionate ophthalmic suspension 0.05% (APP13007) for the treatment of postoperative inflammation and pain following ophthalmic surgery.

APP13007 is a new drug developed and produced by combining a super potent steroid (clobetasol propionate) with Formosa Pharmaceuticals' proprietary APNT nanoparticle formulation platform. The press release shows,This is the first clobetasol propionate medication to receive FDA approval for ophthalmic use, and the first new steroid in the ophthalmology field in 15 years.

Clobetasol Propionate: An Ultra-Potent Corticosteroid

The FDA's approval for ocular use was based on several positive clinical trials. The Phase II clinical trial (CPN-201) conducted in the United States and two Phase III clinical trials (CPN-301 and CPN-302) all employed a randomized, double-blind, placebo-controlled design, enrolling nearly 900 post-cataract surgery patients. The primary clinical endpoint was to evaluate the proportion of subjects with complete resolution of ocular inflammation and complete relief of pain without recurrence after cataract surgery.

Results showed that, in terms of anti-inflammation, after 14 days of continuous medication, the proportion of participants with zero anterior chamber cells (an inflammation indicator) was 58.2% in the treatment group vs 17.3% in the control group; in terms of analgesia, the proportion of participants with a pain index of zero on the 4th day was 81.4% in the treatment group vs 47.4% in the control group; regarding the sustainability of efficacy, the proportion of participants maintaining a pain index of zero from the 4th to the 15th day was 71.6% in the treatment group vs 27.7% in the control group; in terms of safety, data from both groups were comparable, and participants tolerated APP13007 well.

The results of a comprehensive statistical analysis of three clinical studies demonstrated that APP13007 has rapid and sustained effects on inflammation clearance and pain relief, which are 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 after ophthalmic surgery.

In addition, APP13007 has advantages in terms of dosing frequency and tolerability. Most postoperative eye drops are administered 4 times/day, whereas treatment with APP13007 eye drops only requires 2 times/day for 14 days, without the need for tapering, significantly improving patient compliance.

According to a research report by Southwest Securities, China's ophthalmic medical industry market is expected to grow from 41.77 billion yuan in 2014 to 256.31 billion yuan in 2024, with a CAGR of approximately 20%. Additionally, data from the CIC Report shows that China's ophthalmic drug market size is projected to grow at a CAGR of 22.9% from 2025, reaching 20.2 billion US dollars by 2030, surpassing the growth of the global ophthalmic drug market during the same period.

In 2021, Grand Pharmaceutical Group (AimMax Therapeutics) entered into an exclusive licensing agreement with Formosa Pharmaceuticals. Under the agreement, Grand Pharmaceutical will obtain the exclusive development and commercialization rights for APP13007 (referred to as GPN00833 by Grand Pharmaceutical), a modified new drug developed by Formosa for post-operative ocular anti-inflammatory and analgesic use, in mainland China, Hong Kong, and Macao. The deal includes milestone payments of up to $9.5 million (approximately 68.394 million yuan) and a certain percentage of sales royalties.

Currently, GPN00833 has entered Phase III clinical trials in China, planning to enroll 252 patients undergoing cataract surgery, aiming to evaluate the efficacy and safety of GPN00833 in treating postoperative inflammation and pain in Chinese patients after cataract surgery.

In 2023, Eyenovia acquired the U.S. commercialization rights for APP13007 from Formosa Pharmaceuticals for a single-digit million-dollar amount. According to Formosa Pharmaceuticals, there are approximately 7 million ophthalmic surgeries performed annually in the U.S., with a market opportunity of $1.3 billion for steroid and steroid combination ophthalmic drugs. After approval, APP13007 is expected to capture significant market opportunities due to its differentiated advantages.