Lynda Charters

Indian researchers compared a biosimilar of ranibizumab (Lupin) with Lucentis (Genentech) and reported the therapeutic equivalence, safety, and favorable immunogenicity profile of the biosimilar formulation in patients with age-related macular degeneration (AMD).

Ramandeep Singh, MD, lead author from the Department of Ophthalmology, Postgraduate Institute of Medical Education and Research, Chandigarh, India, reported the findings.

Singh and colleagues conducted a prospective, double-blind, 19-center phase-III study that included 202 patients with neovascular AMD. The patients were randomized (1:1) to receive an intravitreal injection of either the biosimilar formulation of ranibizumab or Lucentis 0.5 mg once monthly for 3 months.

The primary endpoint was the percentage of patients who lost fewer than 15 letters of best-corrected visual acuity (BCVA) compared with baseline The investigators assessed the adverse events, the ophthalmic examination and systemic examinations, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies, the investigators described.

Comparison of the Biosimilar and Lucentis

Of the 202 patients, 174 patients (86.14%) completed the study; those patients were evenly divided between the 2 groups.

“The proportion of patients losing fewer than 15 letters from the baseline BCVA score in the study eye was comparable between the two groups,” the authors reported.

Analysis of the 2 groups showed that the 2 drugs were comparable in the percentages of patients who lost fewer than 15 letters of BCVA and the numbers of adverse events.

The numbers of patients who lost fewer than 15 letters, the investigators explained, were within the predefined equivalence margin (intention-to-treat population, 1.0%; 95% CI, -3.3% to 5.4% and per protocol population: 1.2%; 95% CI, -3.2% to 6.4%).

Eleven patients (10.89%) in the biosimilar group and 19 (18.81%) patients in the Lucentis group had at least one treatment-emergent adverse event.

The immunogenicity incidence, ie, the proportion of patients with positive anti-drug antibodies, was numerically lower in the biosimilar group (4.95%) than in the Lucentis group (12.87%).

The investigators concluded that biosimilar ranibizumab showed therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared with Lucentis.

1. Singh R, Chauhan R, Saxena A, et al. A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin's Ranibizumab with Lucentis in patients with neovascular age-related macular degeneration. 

. 2022;70(8):3008-3014. doi: 10.4103/ijo.IJO_2118_21

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The authors noted that the proportion of patients losing fewer than 15 letters from the baseline BCVA score in the study eye was comparable between the two groups.

Efficacy and Safety of Ranibizumab and Lucentis for Wet AMD Compared

The debate continues about the protective effect of eyeglasses against contracting the COVID-19 virus. Researchers from Denmark reported that their results

 were inconclusive regarding whether wearing eyeglasses is linked with a decreased risk of COVID-19 infections.

Rasmus Gregersen, MD, from the Departments of Emergency Medicine and the Center for Clinical Research and Prevention, Copenhagen University Hospital–Bispebjerg and Frederiksberg, and the Department of Public Health, University of Copenhagen, all in Copenhagen, was lead author of the study.

This cohort study included 2120 individuals who were members of the same international rescue corps during the first wave of the pandemic from June to August 2020. During that time, personal protective equipment was not recommended for the general population. The jobs that the participants filled were ambulance, health care, office, field staff positions, firefighters, and roadside assistance.

The main exposure was wearing glasses, including contact lenses and reading glasses, which was assessed in a questionnaire. Persons wearing glasses were compared with those who did not wear glasses. To adjust for potential confounders, information on age, sex, job function, and number of workday contacts were included.

The primary outcome was development of a COVID-19 infection before or during the study period.

Of the 2120 participants, 1279 were in Denmark and 841 in Sweden. Of these, 829 individuals (64.8%) in Denmark and 619 (73.6%) in Sweden wore glasses, the researchers.

“Wearing glasses,” they commented, “was inversely associated with COVID-19 infection in the Swedish cohort (odds ratio [OR], 0.61; 95% confidence interval [CI], 0.37-0.99; p = 0.047; seroprevalence, 9.3%) but not in the Danish cohort (OR, 1.14; 95% CI, 0.53-2.45; p = 0.73; seroprevalence, 2.4%).”

Gregersen reported lower COVID-19 prevalence rates among those who wore glasses in Sweden compared with those who did not (8.1% vs. 12.6%, respectively) but not in Denmark (2.5% vs. 2.2%, respectively).

In Sweden, after adjusting for age, sex, job, and number of workday contacts, wearing eyeglasses was not associated with COVID-19 infection (OR, 0.64; 95% CI, 0.37-1.11; p = 0.11).

When the participants were stratified based on their jobs, a large difference was observed among office staff (OR, 0.20; 95% CI, 0.06-0.70; p = 0.01) but not ambulance staff (OR, 0.83; 95% CI, 0.41-1.67; p = 0.60) or health care staff (OR, 0.89; 95% CI, 0.35-2.30; p = 0.81).

“In unadjusted analyses, we identified an inverse association between wearing glasses and contracting COVID-19 in Sweden but not in Denmark,” the researchers concluded. “After adjusting for available confounding factors, an inverse association was no longer identified, thereby providing inconclusive findings whether wearing one’s own glasses is associated with a decreased risk of COVID-19 infections.”

This article originally appeared on Ophthalmology Times.

1. Gregersen R, Jacobsen RK, Laursen J, et al. Association of COVID-19 infection with wearing glasses in a high-prevalence area in Denmark and Sweden. 

. Published online August 25, 2022. doi:10.1001/jamaophthalmol.2022.3234

The debate continues about the protective effect of eyeglasses against contracting the COVID-19 virus. Researchers from Denmark reported that their results were inconclusive regarding whether wearing eyeglasses is linked with a decreased risk of COVID-19 infections.

Question of Whether Eyeglasses Can Help Protect Against COVID-19 Remains

Ophthalmologists now have another option for the treatment of dry eye disease (DED) in the form of a nasal spray. Basal tear production may be increased by OC-01 nasal spray (Tyrvaya, varenicline solution; Oyster Point Pharma, Inc), a cholinergic agonist thought to pharmacologically neuro-activate the trigeminal parasympathetic pathway receptors in the treatment of DED, according to Marjan Farid, MD, a professor of ophthalmology and director of Cornea, Cataract, and Refractive Surgery 

at Gavin Herbert Eye Institute at the University of California Irvine.

 Natural tears, Farid noted, are better than artificial tears because they contain more than just aqueous (ie, they contain a complex mixture of lipids, proteins, mucins, and electrolytes).

During a media briefing at the American Academy of Ophthalmology 2021 annual meeting, Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, Inc, pointed out that the spray is a highly selective cholinergic agonist that is FDA approved to treat the signs and symptoms of DED as a multidose nasal spray. Patients are given two 15-day supplies, and will take 1 shot of the preservative-free solution in each nostril twice daily about 12 hours apart.

Farid explained that the trigeminal nerve provides the pathway for parasympathetic stimulation of the lacrimal functional unit to activate complete natural tear film. The pathway innervates the lacrimal gland, meibomian glands, and goblet cells, which results in increased basal tear film production as a treatment for DED.

Nau said the spray can be used for mild, moderate, and severe cases of DED. He also pointed out that the phase 3 study indicated consistent outcomes as compared with the ONSET-1 phase 2b trial. Thus far, OC-01 varenicline nasal spray has been evaluated in over 1000 patients in 3 prospective real-world clinical trials: ONSET-1, ONSET-2, and the MYSTIC trials (the last being a phase 2 supportive trial).

In the ONSET-1 phase 2btrials, 3 doses were tested (0.006, 0.03, and 0.06 mg) and compared with the vehicle, and the primary end point was the mean change in the anesthetized Schirmer score. In the ONSET-2 phase 3 trials, the 0.06- and 0.03-mg doses were tested and compared with the vehicle. The primary end point was the anesthetized Schirmer score, that is, the percent of subjects with a 10-mm or greater change from baseline. In the 2 ONSET trials, the responses of all degrees of symptomatic DED were tested and patients could use artificial tears as a supplement.

The integrated data from the ONSET-1 and ONSET-2 trials showed that significantly more patients treated with OC-01 had a 10-mm or greater increase in the Schirmer score and the mean change from baseline compared with the vehicle from baseline to week 4 of treatment. Farid also reported that the DED symptoms began to improve as soon as week 2 of treatment in the ONSET-2 trial, possibly suggesting an early effect from treatment. The onset of action and sustained outcomes were demonstrated in the clinical trials regardless of the degree of the DED. The signs outcomes were measured 5 minutes after the nasal spray was administrated, Farid said.

The drug exhibited a good safety profile. Sneezing was the most common adverse reaction in 82% of subjects in the 0.03-mg dose. Other adverse reactions reported in greater than 5% of subjects were cough, throat irritation, and instillation-site (nasal) irritation. Less subjects discontinued in the treated arm as compared with the vehicle control arm of the studies. “Pharmacologic neuro-activation of natural tear film may represent a new mechanism of action approach and a novel route of administration for the treatment of the signs and symptoms of dry eye disease,” Farid said.

The spray can improve patient adherence with their eye medication, according to Marian Macsai, MD, chief medical officer at Oyster Point, Inc. “Putting drops in your eyes is not an easy task,” she said. “We are cautiously optimistic that this will be preferred by patients and will be readily adopted.”

This article is adapted from Farid’s presentation at the American Academy of Ophthalmology 2021 annual meeting. She is a consultant to Oyster Point Pharma, Inc.

A new treatment option may increase basal tear production in patients. 