Eysuvis (loteprednol etabonate nano-suspension 0.25%) / Kala Pharma - LARVOL DELTA

Drugs for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Quintessence of currently approved and upcoming treatments for dry eye disease. (PubMed, Graefes Arch Clin Exp Ophthalmol) - "Currently, the US Food and Drug Administration (FDA)-approved medical treatments for treatment of DED include cyclosporine formulations (RESTASIS® [cyclosporine 0.05% ophthalmic emulsion], VEVYE® [cyclosporine 0.1% ophthalmic solution], and CEQUA™ [cyclosporine 0.09% ophthalmic solution]), XIIDRA® (lifitegrast), a leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor, EYSUVIS™ (loteprednol etabonate ophthalmic suspension 0.25%), a corticosteroid, and MIEBO™ (perfluorohexyloctane ophthalmic solution), a semifluorinated alkane. TYRVAYA™ (varenicline solution nasal spray), a cholinergic agonist, is another formulation approved for the treatment of the signs and symptoms of DED...Cyclosporine formulations TJO-087 (cyclosporine A nanoemulsion 0.08%), SCAI-001 eye drops (cyclosporine 0.01%, 0.02%) are being evaluated against RESTASIS® and other approved treatments. The potential treatments being assessed include..."

Journal • Review • Conjunctivitis • Dry Eye Disease • Ocular Infections • Ocular Inflammation • Ophthalmology • Sjogren's Syndrome • ICAM1

Perfluorohexyloctane ophthalmic solution (Miebo) for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection (clinicaltrials.gov) - P4 | N=71 | Completed | Sponsor: Price Vision Group | Active, not recruiting ➔ Completed

Trial completion • Immunology • Ophthalmology • Transplant Rejection • Transplantation

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection (clinicaltrials.gov) - P4 | N=71 | Active, not recruiting | Sponsor: Price Vision Group | Recruiting ➔ Active, not recruiting | N=116 ➔ 71 | Trial completion date: Feb 2023 ➔ Aug 2023 | Trial primary completion date: Jan 2023 ➔ Jul 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Ophthalmology • Transplant Rejection • Transplantation

"$KALA Kala Pharmaceuticals Completes Sale of EYSUVIS® and INVELTYS® to Alcon Inc https://t.co/VwKni2oB4w" (@stock_titan)

"Both Eysuvis and Inveltys" (@djmjspin)

"$ALC Alcon to Acquire EYSUVIS Adding to Its Ophthalmic Eye Drop Portfolio https://t.co/hcLhFSkxyH" (@stock_titan)

Ophthalmology

"$KALA Kala Announces Entry into Definitive Agreement to Sell EYSUVIS® and INVELTYS® to Alcon Inc. https://t.co/kYkjg0Owlj" (@stock_titan)

"$KALA Q1 Net product revenues of $1.4M - consisting of $1M of net revenue from EYSUVIS sales and $0.4M of net revenue from INVELTYS. 😬" (@BioStocks)

"$KALA Q4 net revenues from EYSUVIS sales $1.2M 😬" (@BioStocks)

"$KALA Kala Pharmaceuticals Announces EYSUVIS® Now Covered on UnitedHealthcare Commercial and Cigna Medicare https://t.co/wpq4JrsIuZ" (@stock_titan)

Medicare • Reimbursement

Loteprednol etabonate: a formulation for short-term use in inflammatory flares in dry eye disease. (PubMed, Drugs Today (Barc)) - "Use of this MPP formulation results in enhanced penetration of loteprednol etabonate into target tissue on the ocular surface. Eysuvis is the first FDA-approved ocular corticosteroid indicated for dry eye disease."

Journal • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Varenicline nasal spray (Tyrvaya) for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection (clinicaltrials.gov) - P4; N=116; Recruiting; Sponsor: Price Vision Group; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Ophthalmology • Transplant Rejection • Transplantation

Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection (clinicaltrials.gov) - P4; N=116; Not yet recruiting; Sponsor: Price Vision Group

Clinical • New P4 trial • Immunology • Ophthalmology • Transplant Rejection • Transplantation

"EYSUVIS" (@avidresearch)

"$KALA issues are not with Eysuvis, they reported last CC 3k+ scripts being written vs 1.5K actually filled , it is very frustrating to get coverage at the moment" (@francotemarb)

The Role of Steroids in the Management of Dry Eye Disease (Review of Optometry) - "The FDA approval of EYSUVIS (loteprednol etabonate 0.25% ophthalmic suspension) from Kala Pharmaceuticals for the short-term treatment of signs and symptoms of dry eye disease plays an important role in the management of DED patients. In this pearl, we’ll look at potential applications relevant to this labeling."

Online posting

The role of KPI-121 0.25% in the treatment of dry eye disease: penetrating the mucus barrier to treat periodic flares. (PubMed, Ther Adv Ophthalmol) - "Loteprednol etabonate, an ocular corticosteroid, was engineered to break down rapidly after administration to the ocular surface tissues and thereby reduce risks associated with other topical steroids. In clinical trials, short-term treatment with KPI-121 0.25% significantly reduced signs and symptoms of DED compared with its vehicle (placebo). Recently approved KPI-121 0.25%, with its novel drug delivery design and ease of use, has the potential to effectively treat periodic flares of DED experienced by many patients."

Journal • Review • Dry Eye Disease • Immune Modulation • Inflammation • Ocular Inflammation • Ophthalmology

Safety and Efficacy of KPI-121 Ophthalmic Suspension 0.25% for Dry Eye Disease in Three Phase Three Randomized Controlled Trials (ASCRS-ASOA 2021) - "Purpose To evaluate the safety and efficacy of KPI 121 0.25%, a nanoparticle suspension of loteprednol etabonate with proprietary Mucus-Penetrating Particle (MPP) technology, compared to vehicle on signs and symptoms of dry eye disease (DED) in three randomized clinical trials.MethodsA total of 2721 DED subjects ( 18 yrs) were enrolled across three Phase 3 clinical trials (STRIDE 1, STRIDE 2, STRIDE 3). Significant improvements in CH at Day 15 were demonstrated in all 3 trials, STRIDE 1 (p<0.0001), STRIDE2 (p<0.0001), and STRIDE 3 (p<0.0001).The most frequently reported adverse event in all 3 trials was instillation site pain (4.9% for KPI-121 0.25% and 4.0% for vehicle).The incidence of intraocular pressure increase was comparable to vehicle.ConclusionIn all three Phase 3 trials, KPI-121 0.25% improved both signs and symptoms of DED when dosed QID for 2 weeks. KPI 121 0.25% appeared to be safe and well-tolerated and the incidence of IOP elevation was similar..."

Clinical • Dry Eye Disease • Ophthalmology • Pain

"Good article. If licensing is the path forward, what are attractive late stage or commercial targets? Voclosporin, Eysuvis, Tepezza, AXS-05, ublituximab/umbralisib . . . ? Thoughts?" (@BobMarshall63)

"$KALA Kala Pharmaceuticals Announces EYSUVIS® Now Covered by OptumRx https://t.co/aGYQW0R3Uh" (@stock_titan)

Loteprednol 0.25% (Eysuvis) for dry eye disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dry Eye Disease • Ophthalmology

"$KALA Q1 11,600 EYSUVIS prescriptions filled between early Jan and April 23. EYSUVIS net sales $1.64M. Raised $34.7M via ATM in Q1" (@BioStocks)