Phase 3 N=370 Randomized Quadruple-blind Treatment

Efficacy and Safety of APP13007 for Treatment of Inflammation and Pain After Cataract Surgery Including a Corneal Endothelial Cell Sub-study

Ocular Inflammation and Pain After Cataract Surgery

Bottom Line

View on ClinicalTrials.gov: NCT04810962 ↗

Enrolled (actual)

370

Serious AEs

1.4%

Results posted

Jul 2023

Primary outcome: Primary: Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication — 49; 16 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: APP13007, 0.05% (Drug); Matching Vehicle Placebo for APP13007, 0.05% (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Formosa Pharmaceuticals, Inc.
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With ACC Count = 0 in the Operated Study Eye at All Visits From Postoperative Day 8 Through Postoperative Day 15 Without Rescue Medication	49; 16	<0.001 sig
PRIMARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at All Visits From Postoperative Day 4 Through Postoperative Day 15 Without Rescue Medication	139; 60	<0.001 sig
PRIMARY Participants With Treatment-emergent Adverse Events (AEs)	47; 48	—
SECONDARY Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication	55; 24	<0.001 sig
SECONDARY Participants With Anterior Chamber Cell Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication	107; 35	<0.001 sig
SECONDARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD4 Without Rescue Medication	158; 95	<0.001 sig
SECONDARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD8 Without Rescue Medication	161; 86	<0.001 sig
SECONDARY Participants With Ocular Pain Grade = 0 in the Operated Study Eye at POD15 Without Rescue Medication	160; 92	<0.001 sig
SECONDARY Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD4 Without Rescue Medication	132; 89	<0.001 sig
SECONDARY Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD8 Without Rescue Medication	155; 90	<0.001 sig
SECONDARY Participants With Anterior Chamber Flare (ACF) = 0 in the Operated Study Eye at POD15 Without Rescue Medication	159; 79	<0.001 sig
SECONDARY Anterior Chamber Cell Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15	-2.1; -1.0	<0.001 sig
SECONDARY Ocular Pain Grade in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15	-0.6; -0.1	<0.001 sig
SECONDARY Anterior Chamber Flare (ACF) in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD 15	-0.6; -0.2	<0.001 sig
SECONDARY Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD4	-0.08; -0.03	<0.001 sig
SECONDARY Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD8	-0.11; -0.03	<0.001 sig
SECONDARY Best Corrected Visual Acuity in the Operated Study Eye - Change From Baseline (POD1 Prior to Dosing) to POD15	-0.10; -0.02	<0.001 sig
SECONDARY Participants Using of Anti-inflammatory 'Rescue' Medication Through End-of-Treatment	13; 71	<0.001 sig

Summary

This Phase 3 study will evaluate APP13007 in comparison to the matching vehicle placebo in a randomized, parallel-group, double-masked fashion. The subjects will have undergone routine cataract surgery on Day 0 of the study and will be assessed the next day (Post-operative Day; POD1) after uncomplicated surgery for eligibility for randomization to study treatment. The study comprises the Main Study and the Endothelial Cell Sub-study.

Eligibility Criteria

Inclusion Criteria

Patients 18 years of age or older expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
Have a pin-hole corrected visual acuity without other correction of ≤ 1.3 logarithm of the minimum angle of resolution (logMAR) in the study eye to be operated and contralateral eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Visit 1.
Willing and able to comply with study requirements and visit schedule.
Provide signed and dated informed consent.

Exclusion Criteria

Have a known sensitivity or allergy to clobetasol propionate, corticosteroids, or any of the study medication's components including benzalkonium chloride and soybean lecithin or any routine medication required during cataract surgery or for the conduct of study procedures
Have an ACC count > 0 or any evidence of intraocular inflammation (e.g., flare) in either eye at the Screening visit
Have a Grade > 0 on the Ocular Pain Assessment in either eye at the Screening visit

Note: Other inclusion/exclusion criteria apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04810962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.