Hi-Tech Medical College & Hospital

Visual impairment remains a major global health concern associated with disorders such as diabetic retinopathy, glaucoma, cataract, and age-related macular degeneration. Early detection of ocular abnormalities remains essential for preventing irreversible visual loss. Conventional diagnostic methods rely on clinical examination and specialised imaging, yet limitations in accessibility, diagnostic variability, and delayed detection continue to affect effective eye-care delivery in many settings. Advances in digital technologies have introduced innovative diagnostic approaches integrating artificial intelligence (AI), ocular biometric evaluation, and tele-optometry to improve efficiency and reach of ophthalmic care. The objective of this review involves a comprehensive examination of recent developments in digital ophthalmic diagnostics, focusing on AI-based image analysis, biometric measurement technologies, and tele-optometry platforms. Relevant literature addressing AI applications, ocular biometric assessment, and remote ophthalmic screening systems was evaluated to synthesise current knowledge on diagnostic capability and clinical relevance. Current evidence indicates that AI algorithms enable automated interpretation of retinal images and facilitate early identification of ocular diseases. Biometric evaluation provides precise anatomical measurements that support refractive assessment and surgical planning. Tele-optometry systems expand diagnostic access through remote imaging and consultation services, improving screening coverage in underserved populations. Integration of AI, biometric technologies, and tele-optometry demonstrates strong potential to enhance disease detection, strengthen clinical decision support, and expand accessibility of ophthalmic diagnostic services.

Abstract Objectives To evaluate the efficacy and safety of Synthetic Semaglutide Injection manufactured by Sun Pharma (Test arm) with Ozempic® Injection (Reference arm) in Indian patients with Type 2 Diabetes Mellitus (T2DM) in three subgroups based on BMI: <23 kg/m2 (Subgroup 1 [S1]), 23 to <25 kg/m2 (Subgroup 2 [S2]), ≥25 kg/m2 (Subgroup 3 [S3]). Materials and Methods This was a phase III, multicentre, randomized, open-label, active controlled study. Total 314 adults (18-65 years) with T2DM (HbA1c: 7.0-10.5%) on diet/exercise uncontrolled with stable metformin dose (≥1500 mg or maximum tolerated dose) for ≥12 weeks were enrolled. Eligible patients were randomized in a 1:1 ratio and received Test product or Reference product, subcutaneous injections in a weekly dose of 0.25 mg to 2 mg for 24 weeks. [CTRI Registration number: CTRI/2025/02/080592]. Results At baseline, distribution of patients was as follows: 38 patients with BMI <23 kg/m2(S1), 72 patients with BMI 23 to <25 kg/m2(S2) and 204 patients with BMI ≥25 kg/m2(S3). HbA1c reduction from baseline to Week 24 in Test arm was comparable to comparator arm: S1: −2.26 ± 0.91% vs −1.89 ± 0.87% (P = .2028), S2: −2.21 ± 0.76% vs −2.25 ± 0.74% (P = .9033), S3: −1.95 ± 0.82% vs −1.85 ± 0.95% (P = .4848). Significant reduction from baseline HbA1c was observed across all three sub-groups at Week 24 in both the study arms. Significant reductions in post-prandial and fasting blood glucose levels at Week 24 were seen in both the study arms and the changes were comparable across all three BMI subgroups. Proportion of patients achieving HbA1c <7.0% were comparable between the Test and Comparator arms, S1:15 (88.2%) vs 13 (76.5%) (P = .3697), S2: 23 (74.2%) vs 27 (75.0%) (P = .7267), S3: 68 (72.3%) vs 68 (73.1%) (P = .9184) across all three BMI subgroups. Three patients experienced hypoglycaemia. None of the patients required rescue medication. The incidence of treatment-emergent adverse events (TEAEs) was similar in both arms. Most common TEAEs were gastrointestinal events (Diarrhoea, Nausea, Vomiting) in all three subgroups. Study medications were well tolerated. Conclusions Semaglutide injection (Test product) demonstrated comparable glycaemic control to Reference product in T2DM patients uncontrolled on metformin monotherapy across all three BMI subgroups of normal weight, overweight and obese patients.

Abstract Objectives To evaluate the efficacy and safety of Synthetic Semaglutide Injection manufactured by Sun Pharma (Test arm) with Ozempic® Injection (Reference arm) in Indian patients with Type 2 Diabetes Mellitus in three subgroups based on Age: <40 years (Subgroup 1 [S1]), 40 to <50 years (Subgroup 2 [S2]), ≥50 years (Subgroup 3 [S3]) Materials and Methods This was a phase III, multicentre, randomized, open-label, active controlled study. Total 314 adults (18-65 years) with T2DM (HbA1c: 7.0-10.5%) on diet/exercise uncontrolled with stable metformin dose (≥1500 mg or maximum tolerated dose) for ≥12 weeks were enrolled. Eligible patients were randomized in a 1:1 ratio and received Test product or Reference product, subcutaneous injections in a weekly dose of 0.25 mg to 2 mg for 24 weeks. [CTRI Registration number: CTRI/2025/02/080592] Results At baseline, distribution of patients was as follows: 54 patients aged <40 years (S1), 107 patients aged 40 to <50 years (S2) and 153 patients aged ≥50 years (S3). HbA1c reduction (±SD) from baseline to Week 24 in Test arm was comparable to Reference arm across all 3 age subgroups: S1: −1.85 ± 0.70% vs—2.20 ± 0.80% (P = .2220), S2:—2.05 ± 0.87% vs −1.92 ± 0.96% (P = .4542), S3: −2.10 ± 0.83% vs −1.88 ± 0.90% (P = .1557). Significant reduction from baseline in HbA1c was observed across all three sub-groups at Week 24 in both the study arms. Significant reductions in post-prandial and fasting blood glucose levels at Week 24 were seen in both study arms and the changes were comparable across all three age subgroups. Proportion of patients achieving HbA1c <7.0% were comparable between the Test and Reference arms, S1: 19 (86.4%) vs 24 (82.8%) (P = .3426), S2: 36 (72.0%) vs 34 (70.8%) (P = .8843), S3: 51 (72.9%) vs 50 (72.5%) (P = .6315) across all three age subgroups. Three patients experienced hypoglycaemia. None of the patients required rescue medication. The incidence of treatment-emergent adverse events (TEAEs) was similar in both arms. Most common TEAEs were gastrointestinal events (Diarrhoea, Nausea, Vomiting) in all three subgroups. Study medications were well tolerated. Conclusions Semaglutide injection (Test Product) demonstrated comparable glycaemic control to Reference product in T2DM patients uncontrolled on metformin monotherapy across all age groups.

Abstract Objectives To evaluate the efficacy and safety of Synthetic Semaglutide Injection manufactured by Sun Pharma (Test arm) with Ozempic® Injection (Reference arm) in Indian patients with type 2 diabetes mellitus (T2DM) with mild renal impairment (eGFR 60 to <90 mL/min/1.73 m2). Materials and Methods This was a phase III, multicentre, randomized, open-label, active controlled study. Total 314 adults (18-65 years) with T2DM (HbA1c: 7.0-10.5%) on diet/exercise uncontrolled with stable metformin dose (≥1500 mg or maximum tolerated dose) for ≥12 weeks were enrolled. Eligible patients were randomized in a 1:1 ratio and received Test product (manufactured by Sun Pharma) or Reference product, subcutaneous injections in a weekly dose of 0.25 mg to 2 mg for 24 weeks. [CTRI Registration number: CTRI/2025/02/080592]. Results This subgroup analysis included total 109 patients (Test arm [n=55] and Reference arm[n=54]) with mild renal impairment (eGFR 60 to <90 mL/min/1.73 m2). HbA1c reduction (± SD) from baseline to Week 24 was comparable to comparator in this subgroup: −1.95 ± 0.72% vs −1.77 ± 0.88% (P = .3920). Significant reduction from baseline HbA1c was observed in both test arm and reference arm at Week 24. Significant reductions in post-prandial and fasting blood glucose levels at Week 24 were seen in both the study arms and the changes were comparable in this subgroup. Proportion of patients achieving HbA1c <7.0% from baseline to Week 24 were comparable between the Test arm and reference arm 42 (76.4%) vs 42 (77.8%) (P = .7191). One patient experienced hypoglycaemia. None of the patients required rescue medication. The incidence of treatment-emergent adverse events (TEAEs) was similar in both arms (Test arm = 66.2% and Reference arm = 69.5%). Most common TEAEs were gastrointestinal events (Diarrhoea, Nausea, Vomiting). Study medications were well tolerated. Conclusions Semaglutide injection (Test Product) demonstrated comparable glycaemic control to Reference product in T2DM patients uncontrolled on metformin monotherapy with mild renal impairment.

AIM:To evaluate the efficacy, safety and immunogenicity of semaglutide injection (synthetic) (Test group) compared with the Reference semaglutide injection [Ozempic, (Reference group)] in Indian patients with Type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS:This Phase III, randomised, open-label, multi-centre, parallel-group, active-controlled non-inferiority study was conducted across 35 centres in India. Adults aged 18-65 years with T2DM and baseline glycated haemoglobin (HbA1c) ≥ 7.0% to ≤ 10.5% despite stable metformin therapy and diet & exercise control were randomised (1:1) to receive subcutaneous injections of Test semaglutide or Reference semaglutide once weekly for 24 weeks, using an identical dose-escalation regimen (from 0.25 to 2.0 mg per week). The primary endpoint was change in HbA1c from baseline to Week 24. Secondary endpoints included changes in fasting and post-prandial blood glucose, bodyweight and HbA1c < 7.0% achievers, safety and immunogenicity. RESULTS:A total of 314 patients were randomised, and 290 patients completed the study. At Week 24, both treatments produced significant and comparable reductions in HbA1c (Test: -2.04%, Reference: -1.95%; p < 0.0001 within groups). The least-squares mean difference (Test-Reference) was -0.09% (95% CI: -0.26 to 0.09), meeting the pre-specified non-inferiority criterion. Improvements in fasting and post-prandial blood glucose, patients achieving HbA1c < 7.0% and bodyweight were similar between the two groups. The most common treatment-emergent adverse events were predominantly mild-to-moderate gastrointestinal events (Test vs. Reference: 43.3% vs. 46.5%). No anti-drug or neutralising antibodies were detected. CONCLUSIONS:The Test synthetic semaglutide injection demonstrated non-inferior glycaemic efficacy, comparable safety in comparison to Reference semaglutide, supporting its use as an effective therapeutic option for patients with T2DM. Prospectively registered on the Clinical Trials Registry-India, CTRI/2025/02/080592 [Registered on: 14/02/2025], URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTIwODUw&Enc=&userName=.