Ocular Masthead Background

Pipeline

Focused on the Future

Our robust pipeline is strategically diversified across several therapeutic areas in ophthalmology that represent attractive market opportunities and continued growth potential. Our product candidates are engineered to address specific therapeutic needs across ocular surface, anterior segment and posterior segment diseases, including the leading causes of blindness. With an aging population, there is a clear growing need for these types of innovative ocular therapies that may enhance the overall patient and physician experience.

Program Therapeutic Focus Preclinical Early/Mid Clinical Stage (Phase 1 – Phase 2) Pivotal Clinical Trial Stage (Phase 3) FDA Approval Current Status / Anticipated Milestones
Program

Therapeautic Process
Post surgical ocular inflammation and pain
Ocular itching associated with allergic conjunctivitis
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones

Program Therapeutic Focus Preclinical Early/Mid Clinical Stage (Phase 1 – Phase 2) Pivotal Clinical Trial Stage (Phase 3) FDA Approval Current Status / Anticipated Milestones
Program

(axitinib intravitreal implant)

Therapeautic Process
Wet AMD*
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones
Q1 2024 Screen first subject in pivotal trial
Program

AXPAXLI
(axitinib intravitreal implant)

Therapeautic Process
Diabetic Retinopathy
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones
Q2 2024 9-month data from the HELIOS Phase 1 trial
Program

(travoprost intracameral implant)

Therapeautic Process
Glaucoma and ocular hypertension
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones
Q2 2024 Top-line data from Phase 2 trial at ASCRS in April 2024
Program

(dexamethasone intracanalicular insert)

Therapeautic Process
Episodic dry eye disease
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones
Phase 2 trial completed
H1 2024 Complete enrollment for trial to determine placebo comparator for the potential pivotal program
Program

(cyclosporine intracanalicular insert)

Therapeautic Process
Dry eye disease
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones
Phase 2 trial completed
H1 2024 Complete enrollment for trial to determine placebo comparator for the potential pivotal program

Program Therapeutic Focus Preclinical Early/Mid Clinical Stage (Phase 1 – Phase 2) Pivotal Clinical Trial Stage (Phase 3) FDA Approval Current Status / Anticipated Milestones
Program

complement Modulator
(product candidate)

Therapeautic Process
Intermediate and late dry AMD*
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones
Program

Gene Delivery
(intravitreal and suprachoroidal delivery)

Therapeautic Process
Inherited retinal degenerations and protein biofactory indications
Preclinical
Early/Mid Clinical Stage (Phase 1 – Phase 2)
Pivotal Clinical Trial Stage (Phase 3)
FDA Approval
Current Status / Anticipated Milestones

* Age-related Macular Degeneration (AMD)

Caution: All product candidates are investigational and currently undergoing clinical evaluation. This chart is not intended to convey any conclusion of safety of efficacy, and there is no guarantee that any product candidate will successfully complete development or gain FDA approval.

blue eye fibers

Learn more about our FDA-approved products