Effect of OTX-101 in Patients with Dry Eye Disease at Day 14 of Treatment: Ocular Surface Endpoint Results from the Phase 2b/3 Clinical Trial.

Dry eye disease (DED) is a multifactorial disorder characterized by loss of tear film homeostasis, which initiates a cycle of ocular surface inflammation and damage. As ocular discomfort symptoms associated with DED can decrease quality of life, affected patients prefer treatments that rapidly improve the underlying disease process. OTX-101 0.

Optimization of the Ocular Surface Through Treatment of Ocular Surface Disease Before Ophthalmic Surgery: A Narrative Review.

Ocular surface disease commonly exists in individuals requiring ophthalmic surgery and may compromise the structure and function of ocular surface components. Ophthalmic surgery may further affect the ocular surface by injuring the epithelium and sensory nerves, disrupting the tear film, or causing local inflammation. Medical management of ocular surface disease prior to ophthalmic surgery aids in reducing inflammation, resolving infection, improving epithelial pathology, stabilizing the tear film, and easing patient symptoms, promoting positive long-term outcomes and minimizing the incidence of postoperative complications.

Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca.

Background: OTX-101 is approved for treatment of keratoconjunctivitis sicca (KCS). We present results of a phase 3 worse-eye efficacy analysis and 1-year safety extension.

Methods: During the double-masked treatment phase, patients with bilateral KCS were randomized 1:1 to 12 weeks OTX-101 or vehicle 1 drop per eye twice daily.

Pterygium Surgery Utilizing Limbal Conjunctival Autograft and Subconjunctival Amniotic Membrane Graft in High-Risk Populations.

Objective: To measure the outcomes of primary pterygium excision with a limbal conjunctival autograft when combined with the adjunctive use of a prophylactic subconjunctival graft of amniotic membrane to decrease the recurrence rate after surgery in an ethnically diverse population with a statistically higher risk for recurrence (African American, Asian, Caribbean, Asian, Latin).

Design: This is a retrospective, non-comparative study of post-operative outcomes.

Participants: A total of 355 patients, totaling 493 eyes, with clinically significant, primary pterygia.

Managing Dry Eye Disease and Facilitating Realistic Patient Expectations: A Review and Appraisal of Current Therapies.

Dry eye disease (DED) is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by ocular signs and symptoms such as corneal and conjunctival damage, patient discomfort, and visual disturbance. The prevalence of DED ranges from 5%-33%. Patients with DED may have a reduced quality of life due to their discomfort and visual disturbances.

An Evaluation of Staphylococci from Ocular Surface Infections Treated Empirically with Topical Besifloxacin: Antibiotic Resistance, Molecular Characteristics, and Clinical Outcomes.

Introduction: Understanding antibiotic resistance and toxin profiles among staphylococcal isolates in ocular infections can aid in therapeutic management and infection prevention strategies. We evaluated in vitro antibiotic resistance patterns and molecular traits of staphylococci isolated from patients with ocular surface infections. We also report on clinical outcomes for these patients following empirical treatment with topical besifloxacin ophthalmic suspension 0.

Use of topical bromfenac for treating ocular pain and inflammation beyond cataract surgery: a review of published studies.

Topical ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat postoperative inflammation and pain following cataract surgery and for treatment and prophylaxis of pseudophakic cystoid macular edema (CME). Bromfenac is a brominated NSAID with strong in vitro anti-inflammatory potency. Like other ophthalmic NSAIDs, bromfenac is often used outside of the cataract surgery setting.

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials.

Keratoconjunctivitis sicca (KCS), a multifactorial disease, is the most common ocular condition for patients seeking medical treatment and is characterized by ocular burning, stinging, and dryness. This pooled analysis examined the effect of OTX-101 0.09% versus vehicle on the total and individual conjunctival staining in patients with KCS from phase 2b/3 and phase 3 studies.

Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Corneal Staining in Patients With Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies.

Background: Keratoconjunctivitis sicca affects 5% to 33% of the population and is often accompanied by symptoms such as burning and dryness. This pooled analysis evaluated total and central corneal fluorescein staining (CFS) in patients receiving OTX-101 0.09% or vehicle in phase 2b/3 and 3 studies and whether improvements in corneal staining correlated with improved visual acuity.

A Phase 3, Randomized, Double-Masked Study of OTX-101 Ophthalmic Solution 0.09% in the Treatment of Dry Eye Disease.

Purpose: To evaluate the safety and efficacy of OTX-101, a novel aqueous nanomicellar formulation of cyclosporine (0.09%), in the treatment of patients with dry eye disease (DED).

Design: A randomized, multicenter, vehicle-controlled, double-masked, phase 3 clinical trial.

A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease.

Purpose: The aim of this study was to evaluate the safety and efficacy of OTX-101, a clear nanomicellar aqueous solution of cyclosporine, in the treatment of dry eye disease (DED).

Patients And Methods: This was a 12-week multicenter, randomized, prospective, double-masked, vehicle-controlled, dose-ranging clinical trial. Subjects were adults aged ≥18 years, with a total conjunctival staining score of ≥3 and ≤9, and global DED symptom score ≥40 (0-100 visual analogue scale).

Besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial keratitis: a retrospective safety surveillance study.

Purpose: The objective of this study was to collect and evaluate retrospective safety information about the use of besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial keratitis.

Methods: This was a retrospective, postmarketing surveillance study conducted at 10 clinical centers in the United States.

Efficacy and safety of bromfenac for the treatment of corneal ulcer pain.

Purpose: To evaluate the efficacy and safety of bromfenac ophthalmic solution 0.09% (Xibrom™, ISTA Pharmaceuticals Inc., Irvine, CA, USA) for treating pain associated with corneal ulcers.

Efficacy of topical cyclosporine for the treatment of ocular rosacea.

Introduction: This study was designed to compare the efficacy of cyclosporine ophthalmic emulsion 0.05% with an artificial tear solution for the treatment of rosacea-associated eyelid and corneal pathology.

Methods: Double-masked, randomized, 3-month clinical trial of 37 patients with rosacea-associated eyelid and corneal changes (defined as lid margin telangiectasia, meibomian gland inspissation, and/or fullness of the lid margin).

Ketorolac tromethamine 0.4% as a treatment for allergic conjuctivitis.

Background: Acular LS (ketorolac tromethamine 0.4%) ophthalmic solution, a reformulation of the original Acular (ketorolac tromethamine 0.5%), is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.

Long-term follow-up of conjunctival and corneal intraepithelial neoplasia treated with topical interferon alfa-2b.

Objective: To evaluate the long-term recurrence rate (>1 year) of conjunctival and corneal intraepithelial neoplasia (CIN) treated with topical interferon alfa-2b.

Design: Retrospective, noncomparative, interventional case series.

Participants: Twenty-eight eyes of 26 patients from 2 institutions, treated between April 1997 and June 2005, with CIN lesions utilized topical interferon alfa-2b drops 4 times daily until clinical resolution was achieved.

Ketorolac during the induction phase of cyclosporin-A therapy.

Purpose: The aim of this study was to determine if the concomitant use of ketorolac 0.4% and cyclosporin-A improves patient comfort during the induction phase in treating chronic dry eye disease.

Methods: Patients (n = 52) with clinically diagnosed dry eye were randomized to receive either cyclosporin-A monotherapy twice-daily (BID) or a BID adjunctive regimen of ketorolac, followed by the instillation of cyclosporin-A 10 min later.