November 2025

PDR Drug Update 

Pharmacological Treatment Options for Presbyopia

The vast majority of adults experience worsening of vision as they age. The most common cause of this is presbyopia, or age-related blurry near vision, also known as farsightedness. Presbyopia typically begins in adults over 40 years of age and affects over 120 million individuals in the US. This loss of ability occurs as the crystalline lens in the eye becomes less flexible with age, making tasks such as reading increasingly difficult. Until recently, management relied mainly on glasses, contact lenses, or surgical options. Now, pharmacological approaches to vision correction are becoming available for prescribers to offer patients interested in alternative options.

Most recently, Vizz (aceclidine) ophthalmic solution received FDA approval for the treatment of presbyopia in adults. Vizz is a daily eye drop containing aceclidine, a cholinergic muscarinic receptor agonist that works by instigating contraction of the iris sphincter muscle and constricting the pupil, increasing the depth of focus and improving near vision. This mechanism is reversible and does not alter the natural anatomy of the eye.

Clinical trials demonstrated that Vizz improves near visual acuity without substantially compromising distance vision. Dosage for Vizz is two drops per affected eye daily; patients will instill one drop in each eye, wait 2 minutes, then instill one more drop in each treated eye. Vizz’s onset of effect is typically observed within 30 minutes, and benefits can last up to ten hours. Commonly reported adverse reactions include dim or blurred vision, headache, eye irritation, and eye redness.

Other pharmacologic approaches to presbyopia include pilocarpine-based drops such as Vuity (pilocarpine hydrochloride). Vuity works by stimulating the ciliary muscle as well as the iris sphincter in order to improve near vision. However, this mechanism may sometimes lead to a ciliary spasm, which can cause blurry distance vision and eye strain. Vizz’s selective mechanism may reduce the risk of ciliary spasm, providing an alternative treatment for patients who experience this side effect.

Emerging therapies, such as a combination of carbachol and brimonidine, continue to be studied for treatment of presbyopia. Nonpharmacologic management, including corrective lenses, remains the standard of care. Vizz adds a new, non-invasive treatment option, allowing providers and patients to select an approach based on visual needs, tolerability, and preference. Stay informed about emergent drug information, including treatment options for presbyopia, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Bondlido

The FDA has approved Bondlido (lidocaine) topical system for use in adults for relief of pain associated with post-herpetic neuralgia. Learn more about Bondlido

Clotic

The FDA has approved Clotic (clotrimazole) otic solution for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older. Learn more about Clotic

Contepo

The FDA has approved Contepo (fosfomycin) for injection, for intravenous use for the treatment of adult patients with complicated urinary tract infections, including acute pyelonephritis, caused by susceptible isolates of Escherichia coli and Klebsiella pneumoniae. Learn more about Contepo

Enoby

The FDA has approved Enoby (denosumab-qbde), a biosimilar referencing Prolia (denosumab), for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of the bone. Learn more about Enoby

Epioxa

The FDA has approved Epioxa (riboflavin 5’-phosphate) ophthalmic solution for use in epithelium-on corneal collagen cross-linking for the treatment of keratoconus in adults and pediatric patients aged 13 years and older, in conjunction with the O2n System and the Boost Goggles. Learn more about Epioxa

Eydenzelt

The FDA has approved Eydenzelt (aflibercept-boav), a biosimilar referencing Eylea (aflibercept), for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Learn more about Eydenzelt

Ferabright

The FDA has approved Ferabright (ferumoxytol) injection for magnetic resonance imaging of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. Learn more about Ferabright

Inluriyo

The FDA has approved Inluriyo (imlunestrant) 200mg tablets, an oral estrogen receptor antagonist, for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy. Learn more about Inluriyo

Jascayd

The FDA has approved Jascayd (nerandomilast) tablets as an oral treatment option for idiopathic pulmonary fibrosis in adult patients. Learn more about Jascayd

Javadin

The FDA has approved Javadin (clonidine hydrochloride) oral solution for the treatment of hypertension in adult patients to lower blood pressure. Learn more about Javadin

Lasix Onyu

The FDA has approved the drug-device combination Lasix Onyu (furosemide) injection for the treatment of edema (due to fluid overload) in adult patients with chronic heart failure. Learn more about Lasix Onyu

Lynkuet

The FDA has approved Lynkuet (elinzanetant) 60mg capsules, the first and only dual neurokinin targeted therapy, neurokinin 1 and neurokinin 3 receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. Learn more about Lynkuet

Palsonify

The FDA has approved Palsonify (paltusotine) for the first-line treatment of adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. Learn more about Palsonify

Qivigy

The FDA has approved Qivigy (immune globulin intravenous, human-kthm) 10% solution, indicated for treatment of adults with primary humoral immunodeficiency. Learn more about Qivigy

Rhapsido

The FDA has approved Rhapsido (remibrutinib) as an oral treatment for adult patients with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment. Learn more about Rhapsido

Xtrenbo

The FDA has approved Xtrenbo (denosumab-qbde), referencing Xgeva (denosumab) and is indicated for treating osteoporosis in postmenopausal women, preventing skeletal-related complications in cancer that has spread to the bone, and treating unresectable giant cell tumor of the bone. Learn more about Xtrenbo

FDA First-Time Generic Approvals

Progesterone Vaginal Insert

The FDA has approved Progesterone Vaginal Insert, 100mg, as a generic to Endometrin (progesterone). Progesterone Vaginal Insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of a treatment program for infertile women. Learn more about Progesterone Vaginal Insert

FDA New Indications

Blenrep

The FDA has approved Blenrep (belantamab mafodotin-blmf) in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. Learn more about Blenrep

Evkeeza

The FDA has approved Evkeeza (evinacumab-dgnb) ANGPTL3 antibody as an adjunct to diet and exercise and other lipid-lowering therapies for the treatment of children from age 1 to less than 5 years old with homozygous familial hypercholesterolemia. Learn more about Evkeeza

Gazyva

The FDA has approved Gazyva (obinutuzumab) for the treatment of adult patients with active lupus nephritis who are receiving standard therapy, as well as a shorter 90-minute infusion time after the first infusion, for eligible patients. Learn more about Gazyva

Libtayo

The FDA has approved Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation. Learn more about Libtayo

Olpruva

The FDA has approved Olpruva (sodium phenylbutyrate) as adjunctive therapy to standard of care, which includes dietary management, for the chronic management of adult and pediatric patients aged 1 year and older who weigh 7kg or greater, with urea cycle disorders involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase. Learn more about Olpruva

Revuforj

The FDA has approved Revuforj (revumenib) for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. Learn more about Revuforj

Rinvoq

The FDA has approved an updated indication for Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis (UC) and moderately to severely active Crohn's disease (CD). Previously, Rinvoq was indicated for adults with moderately to severely active UC or CD who had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers. The updated indication statement also allows the use of Rinvoq for patients who have received at least one approved systemic therapy, in the event TNF blockers are clinically inadvisable. Learn more about Rinvoq

Rybelsus

The FDA has approved Rybelsus (semaglutide) for reducing the risk of major adverse cardiovascular events such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they have had a prior CV event or not. Learn more about Rybelsus

Simponi

The FDA has approved Simponi (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis, weighing at least 15kg. Learn more about Simponi

Tecentriq plus Lurbinectedin

The FDA has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with Zepzelca (lurbinectedin) for the maintenance treatment of adult patients with extensive-stage small cell lung cancer whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin, and etoposide. Learn more about Tecentriq plus lurbinectedin

Tezspire

The FDA has approved Tezspire (tezepelumab) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps. Learn more about Tezspire

Tremfya

The FDA has approved Tremfya (guselkumab) for the treatment of children six years and older who also weigh at least 40kg with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, or active psoriatic arthritis. Learn more about Tremfya

Uzedy

The FDA has approved Uzedy (risperidone) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. Learn more about Uzedy

Xeljanz

The FDA has approved Xeljanz (tofacitinib) for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis, who have had an inadequate response or intolerance to one or more TNF blockers. Learn more about Xeljanz

Yuflyma

The FDA has approved expanded indications for Yuflyma (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa in adolescent patients aged 12 years and older, and uveitis in pediatric patients aged 2 years and older. Learn more about Yuflyma

Zoryve

The FDA has approved Zoryve (roflumilast) cream 0.05% for the topical treatment of mild-to-moderate atopic dermatitis in children 2 to 5 years of age. This is the sixth approval for Zoryve. Learn more about Zoryve

FDA Labeling Changes

Olpruva

The FDA has updated the labeling for Olpruva (sodium phenylbutyrate) with a new Limitation of Use, stating Olpruva is not recommended for patients younger than 1 year of age due to the volume of free water required for daily administration. Learn more about Olpruva

FDA REMS

Caprelsa

The FDA has removed the REMS program for Caprelsa (vandetanib), a thyroid cancer medication. The REMS had been required to ensure appropriate heart rhythm monitoring and safe use. After more than a decade of oversight, REMS assessments reported no cases of Torsades de pointes or unexplained sudden deaths among US patients taking Caprelsa. Clinical data also showed no concerning patterns of heart rhythm problems. Learn more about Caprelsa

Enoby

The FDA has approved a REMS for Enoby (denosumab-qbde). The goal of the Enoby REMS is to mitigate the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including dialysis-dependent patients, associated with Enoby. Learn more about Enoby

Labeling Updates - No updates this month