ARVO Congress 2023: New clinical data to support Alfa Intes products.

At the ARVO 2023-Association for Research in Vision & Ophthalmology Annual Meeting-held in New Orleans from April 23 to 27, the results of two studies conducted to support products and active ingredients of interest to Alfa Intes were presented.

In particular, a spontaneous post-marketing clinical study was presented in which the efficacy of Idroflog TM (an "active" tear substitute) was evaluated in patients with mild-to-moderate Dry-eye associated with Meibomian gland dysfunction; and a second study highlighting the improved in vitro sensitivity of Moxifloxacin and Chloramphenicol active ingredients with antimicrobial activity found in the product Quimox TM and the combination Ziclor TM, respectively.

- "Effects of a hyaluronic acid and hydrocortisone-based tear substitute on signs and symptoms of patients with Dry-eye."

This first, spontaneous post-marketing study was conducted by Dr. Giovanni Tedesco in collaboration with Prof. Giuseppe Giannaccare, Ophthalmology, Magna Graecia University of Catanzaro.  Thirty-eight patients with mild-to-moderate dry eye associated with meibomian gland dysfunction (MGD) were enrolled. Inclusion criteria were: mean noninvasive tear film break-up time (NIKBUTa) value < 14 sec; lipid layer thickness (LLT) < 75 nm; OSDI score between 13 and 32.

Nineteen patients were treated with an eye drop based on 0.2% hyaluronic acid and 0.001% hydrocortisone (Idroflog TM). The remaining patients were treated with a tear substitute containing hyaluronic acid and trehalose (control group). The dosage was 1 drop 4 times/day for 3 months for both groups. Patients were examined at baseline, after 15 , 45 and 90 days with the Keratograph 5M® to detect NIKBUTa and with the LipiView® to measure LLT lipid layer thickness. Symptoms were assessed by OSDI questionnaire at the same times.

The results showed a statistically significant difference between the two groups at all follow-up visits in terms of mean NIKBUT (p<0.001 study group vs control group) and change in LLT lipid thickness (p<0.001) in favor of the Idroflog TM . In addition, only eyes belonging to the Idroflog TM treatment group showed a significant increase in LLT at all visits compared with T0. All patients showed a significant decrease in OSDI score with time (p<0.001), with no significant differences between groups.

The study concluded that both treatments induced significant improvement in ocular discomfort. However, eye drops with hyaluronic acid and hydrocortisone reported better performance with statistically significant increase in mean NIKBUT and LLT lipid thickness values than eye drops with hyaluronic acid and trehalose. Probably, the low dose of hydrocortisone improves tear film stability in MGD-associated dry eye by reducing inflammation of the Meibomian glands, resulting in increased production of the lipid component.

The "active" tear substitute based on hyaluronic acid and 0.001% hydrocortisone (Idroflog TM) results in substantial benefits over traditional artificial tears. Indeed, it is able to act not only on symptoms but also on clinical signs of the condition by significantly restoring the qualitative composition of tears and their functionality.

- "Characterization of conjunctival microflora and antibiotic sensitivity pattern in patients undergoing cataract surgery."

The second spontaneous study was conducted by Prof. Aldo Vagge, DiNOGMI, University of Genoa, and Prof. Giuseppe Giannaccare, Ophthalmology University Magna Grecia of Catanzaro, in collaboration with the Veneto Eye Bank Foundation, Mestre, and at the Dr. Marcello Santocono Eye Center, Catania. The objective of the study was to characterize the conjunctival flora of patients scheduled for cataract surgery and to determine the susceptibility profile of the isolates to different topical antibiotics, which are commonly used in ophthalmology.

Conjunctival swabs were performed in patients awaiting senile cataract surgery before starting any prophylactic treatment. Swabs were processed for microbial load detection and species identification. Selective culture media were used, and bacteria were identified using MicroScan Specialty ID panels (Beckman Coulter®). Antimicrobial Sensitivity for Netilmycin, Tobramycin, Ofloxacin, Levofloxacin, Moxifloxacin, Chloramphenicol, and Azithromycin was assessed using the diskette diffusion method (Kirby-Bauer). Oxacillin sensitivity was useful in identifying bacteria of the genus Staphylococcus aureus (MRSA) and methicillin-resistant Staphylococcus epidermidis (MRSE).

Data from 88 eyes of 44 patients (19 males, 25 females, mean age ± SD: 75 ± 12 years) were included. Among the swabs analyzed, 61.4% showed only saprophytic flora, 30.7% showed only potentially pathogenic flora, and 8.0% showed both. S. epidermidis (20.5%), S. intermedius (18.2%) and S. aureus (14.8%) were the most frequently found isolates; MRSA and MRSE accounted for 8.0% and 6.8% of the isolates, respectively. Gram-negative bacteria such as Pseudomonas fluorescens, Serratia marcescens, Moraxella lacunata and Morganella morgani constituted only 9% of all isolates. The antibiotic susceptibility profile showed high sensitivity for Moxifloxacin, 100% for Gram-negative isolates and a range of 83-100% for Gram-positive. All isolates also showed a good sensitivity profile (67-100%) toward Chloramphenicol, with the exception of Pseudomonas spp due to its intrinsic resistance to this molecule. Among the aminoglycosides, the susceptibility of isolates was best for Netilmycin (50-100%), although, levels of resistance were reported among Gram positives. Among Gram positives, the lowest susceptibility profile was found, for ofloxacin (16.7-56.3%) among the fluoroquinolones tested.

The study concluded that a significant percentage of eyes that were candidates for cataract surgery had potentially pathogenic flora alone or in association with saprophytic organisms. Staphylococci were the most frequently isolated bacteria. All microorganisms isolated showed excellent sensitivity to both Moxifloxacin and Chloramphenicol. For antibiotics such as Tobramycin and Ofloxacin, which are widely used in ophthalmology, the ocular isolates confirmed that they also had a profile of reduced in vitro sensitivity in this study.