Inveltys (loteprednol etabonate nano-suspension 1%) / Kala Pharma - LARVOL DELTA

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

"Both Eysuvis and Inveltys" (@djmjspin)

"$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)

KPI-121 1% for pain and inflammation in ocular surgery. (PubMed, Pain Manag) - "Results from clinical trials demonstrate that KPI-121 1% is effective and well tolerated. KPI-121 1% uses mucopenetrative technology for ophthalmic use and is the only US FDA-approved twice-daily ocular corticosteroid indicated for the treatment of inflammation and pain after ocular surgery."

Journal • Immunology • Inflammation • Ocular Inflammation • Ophthalmology • Pain

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

Journal • Dry Eye Disease • Ophthalmology

"$KALA Q4 net product revenues of $2.2M, consisting of $1.9M from INVELTYS sales and $0.3M from EYSUVIS sales. Raised $18M in Jan via ATM" (@BioStocks)

A review of the clinical applications of drug delivery systems for the treatment of ocular anterior segment inflammation. (PubMed, Br J Ophthalmol) - "Dextenza, INVELTYS, Dexycu and Bromsite are examples of DDS that have enjoyed success in clinical trials leading to FDA approval. Nanoparticles and ocular iontophoresis form the next wave of DDS that have the potential to replace topical steroids eye-drops as the treatment of choice for anterior segment inflammation. With the current relentless pace of ophthalmic drug delivery research, the pursuit of a new standard of treatment that eliminates the problems of low bioavailability and patient compliance may soon be realised."

Clinical • Journal • Review • Cataract • Complement-mediated Rare Disorders • Glaucoma • Immunology • Inflammation • Macular Edema • Ocular Inflammation • Ophthalmology • Uveitis

The Future of OSD? (The Ophthalmologist) - "Ocular surface disease (OSD) is more widespread than many clinicians once thought. Recent studies have shown that the majority of patients presenting for cataract surgery have ocular signs of dry eye or Meibomian gland dysfunction (MGD), regardless of whether they report symptoms...Although we are fortunate to have a wide array of treatments for OSD, including artificial lubricants, topical anti-inflammatory drops, thermal pulsation, and punctal occlusion, many patients get insufficient relief from these approaches. There are a number of new and pipeline treatments designed to address the gaps in treatment."

Online posting

Dry Eye Therapeutics in the Pipeline (Cataract & Refractive Surgery Today) - "Preeya K. Gupta, MD: As an investigator in all four trials, I found it exciting to see the rapid improvement in corneal staining and to meet the trials' conjunctival hyperemia endpoint....Eric D. Donnenfeld, MD: There are now three FDA-approved medications that address inflammation as a means to manage DED: cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan); cyclosporine ophthalmic solution 0.09% (Cequa, Sun Ophthalmics); and lifitegrast ophthalmic solution 5% (Xiidra, Novartis)....Ehsan Sadri, MD, FACS, FAAO: Treating Demodex blepharitis is challenging. Lid scrubs with baby shampoo, warm compresses, and combination steroid-antibiotic ointments...William B. Trattler, MD: Patients with Fuchs dystrophy who experience vision loss often defer treatment because it involves surgery. Having a nonsurgical option such as treatment with TTHX-1114 could lead to earlier intervention and better visual outcomes for patients."

Online posting

Video: KPI-121 shows promising results as first-line dry eye therapy (Healio) - "In this video from the virtual American Society of Cataract and Refractive Surgery meeting, Edward J. Holland, MD...discusses his poster on phase 2 results with KPI-121 (Kala Pharmaceuticals) as a potential new topical therapy for the treatment of dry eye."

Video

Phase 3 Results for KPI 121 1% Ophthalmic Suspension Dosed b.i.d. vs. Placebo for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery (AAO 2018) - "Conclusion KPI-121 1% b.i.d. was safe and well tolerated and effectively resolved ocular inflammation and pain in postop cataract surgery patients. "

Clinical • P3 data • Dry Eye Disease • Ocular Inflammation • Ophthalmology

Inveltys: Patent expiry related to MPP technology in 2033 (28th Annual Oppenheimer Healthcare Conference, Kala Pharma)

Patent • Dry Eye Disease • Ophthalmology

Inveltys: Patent expiry related to MPP technology in 2033 (28th Annual Oppenheimer Healthcare Conference, Kala Pharma)

Patent • Dry Eye Disease • Ophthalmology

Kala Pharmaceuticals reports fourth quarter and full year 2017 financial results (Businesswire) - P3, N=918; NCT02813265; P3, N=909; NCT02819284; "Pooled ITT populations from STRIDE 1 and STRIDE 2: A positive treatment effect was observed for the primary symptom endpoint of ocular discomfort at day 15 (p<0.0001) in this pooled population...pooled results in 2 exploratory analyses in subgroups defined by geographical regions of east and west achieved p-values of 0.0071 and 0.0021 respectively and north and south achieved p-values of 0.0002 and 0.0176, respectively."

Retrospective data • Dry Eye Disease • Ophthalmology

Kala Pharmaceuticals announces topline results for two phase 3 trials (STRIDE 1 and STRIDE 2) of KPI-121 0.25% in dry eye disease (Kala Pharma) - P3, N=918; N=909; STRIDE 1 & STRIDE 2; Sponsor: Kala Pharmaceuticals; "In the STRIDE 1 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 in the ITT population (p<0.0001) and the primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in the ITT population (p<0.0001)...In the STRIDE 2 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 in the ITT population (p<0.0001)."

P3 data: top line • Dry Eye Disease • Ophthalmology

Kala Pharmaceuticals announces New Drug Application for Inveltys (KPI-121 1%) has been accepted for review by the U.S. Food and Drug Administration (Kala Pharma) - "Kala Pharmaceuticals...announced that the New Drug Application (NDA) for INVELTYSTM (KPI-121 1%)...has been accepted for review by the United States Food and Drug Administration (FDA). The FDA, in its 74-day letter, indicates that the application is sufficiently complete to permit a substantive review and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018."

NDA • PDUFA date • Ophthalmology

Kala Pharmaceuticals reports fourth quarter and full year 2019 financial results (Businesswire) - "We are on track to...resubmit our New Drug Application to the U.S. Food and Drug Administration in the second quarter of 2020....For the quarter ended December 31, 2019, Kala reported net product revenue of $1.2 million relating to sales of INVELTYS...For the full year ended December 31, 2019, R&D expenses were $27.3 million...was primarily due to a decrease in INVELTYS-related manufacturing and headcount costs...and the NDA filing fee for EYSUVIS..."

Commercial • NDA

Blog: FDA approves, but payers decide (Healio) - "Insurers, though, truly wield the power to make or break a new drug's or device's success. The dreaded prior authorization process that varies widely between product and specific insurance plan creates endless work and frustration and often leads doctors to simply give up on a new product. In our specialty, this process has already caused very slow adoption of drugs like Xiidra (lifitegrast, Novartis) and newer formulations of cyclosporine (Cequa, Sun Pharma) and loteprednol (Lotemax SM, Bausch + Lomb; Inveltys, Kala)."

Blog • Regulatory

Don’t shy away from steroid use for surgery patients (Optometry Times) - "Lotemax SM was also designed to be patient-friendly with the moisturizing ingredients glycerin and propylene glycol, a pH close to that of human tears and the lowest preservative percentage (0.003% benzalkonium chloride), in a loteprednol etabonate formulation. The same was done by Kala Pharmaceuticals with the introduction of its steroid Inveltys (loteprednol etabonate ophthalmic suspension 1%), which utilized Kala’s proprietary AMPPLIFY Drug Delivery Technology to enhance penetration into target tissues of the eye."

Online posting

Innovations in topical ocular corticosteroid therapy for the management of postoperative ocular inflammation and pain (AJMC) - "Selection of an appropriate topical corticosteroid depends on drug-specific variables such as AE profile, efficacy, potency, dosing, patient-specific administration needs, and formulation properties aimed at minimizing precorneal drug loss, increasing drug residence time on the ocular surface, and maximizing bioavailability and the amount of drug delivered into the ocular tissues."

Online posting

Dry eye developments: Anti-inflammatory therapeutics for ocular surface management (EyeWorld) - "'Ocular surface disease has many different etiologies, but inflammation is a common component in the majority of patients,' said Edward Holland, MD....Anti-inflammatory agents currently in use for ocular surface management broadly fall into two categories: steroids, mainly loteprednol etabonate, which 'are immediate and work consistently,' said John Hovanesian, MD...'There is need of an anti-inflammatory to inhibit corneal neovascularization and one to inhibit inflammation-induced conjunctival fibrosis as occurs in mucus membrane pemphigoid and Stevens- Johnson syndrome,' Dr. Pflugfelder said."

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Introducing a new ocular corticosteroid powered by AMPPLIFY technology (Cataract & Refractive Surgery Today) - "Sheri L. Rowen, MD, FACS: Inflammation is a risk with any ocular surgery. Even with the best surgical technique, the blood-aqueous barrier is compromised, which may lead to inflammation in the aqueous humor....William Trattler, MD: Drs. Rowen and Sood offered a great overview of the benefits of controlling inflammation with topical steroids. The challenge is that there are some risks associated with steroids, the biggest concern being elevated eye pressure."

Online posting

Dry-eye therapies: What’s next? (Review of Ophthalmology) - "Karl G. Stonecipher, MD, and his colleagues are conducting a retrospective review combining low-level light therapy with intense pulsed light using a new device....'The low-level light therapy or photobiomodulation basically heats the glands endogenously, and it’s combined with no-gel IPL,' Dr. Stonecipher says....'We have some exciting times ahead,' Dr. Sheppard says. 'We have a couple of drugs that will be out in the next year or two, and then a slew of drugs will be coming out in the next three to five years.' Dr. Pflugfelder is more circumspect. 'I think eventually there will be new classes of drugs that may be more effective than what we have right now,' he says."

Media quote

Cataract surgery comanagement from the other side (Optometry Times) - "Modern cataract surgery has become so advanced that it is very routine and reliable with low risk for complications. Our surgeons feel confident in sending patients back to their optometrists, knowing that ODs excel at identifying and managing potential complications....In our experience, we have found that it is best not to allow generic substitutions for any of these drugs. We understand that cost is always a concern, but the small savings is not worth the risk. We find that generics are not as reliable and are more likely to induce ocular surface problems or CME."

Online posting