Recommendations of the SEC (Ophthalmology) made in its 42nd meeting held on 29.09.2020 at CDSCO HQ New Delhi.

Agenda File Name & Drug Recommendations Firm Name No Name, Strength New Drugs Division In light of earlier recommendation of SEC dated 19.08.2020, the firm presented toxicity data along with digital pictures from the animal data for Netrasudil 0.02% w/v + ND/MA/19/000024 0.005% w/v Ophthalmic solution before the 0.02% M/s Ajanta Pharma committee. 1. w/v + Latanoprost limited The committee noted that the firm 0.005% w/v has completed Phase III CT with Ophthalmic solution Netarsudil 0.02% w/v Ophthalmic solution. After detailed deliberation, the committee recommended for grant of permission to conduct the Phase III CT as per protocol presented. Firm presented their proposal along with the Phase III CT report before ND/MA/18/000016 the committee. M/s Ajanta Pharma After detailed deliberation 2. Netarsudil 0.02% e/v limited committee recommended for grant Ophthalmic solution of permission to manufacture & market Netarsudil 0.02% w/v Ophthalmic solution. ND/CT18/FF/2020/2 Firm didn’t turn up for presentation 1772 M/s Santen India Pvt. 3. Diquafosol Sodium Ltd ophthalmic solution 3% w/v

Biological Division Firm presented their proposal for 4-51/Reliance/PAC- approval of additional indications. R-Ranibizumab/ M/s Reliance Life The committee noted that the drug 4. 2020-BD Sciences Pvt. Ltd. has been recently approved for Ranibizumab marketing in the country.

After detailed deliberation, the

SEC (Ophthalmology) 29.09.2020 committee recommended that the firm should submit safety data from the Phase IV clinical trial before considering the approval of additional indications.

Firm presented their proposal along with the protocol for conduct of Phase IV Clinical Trial before the committee.

After detailed deliberation, the committee recommended for grant of permission to conduct the Phase IV Clinical Trial subject to the BIO/CT04/FF/2020/ following conditions – 20666 (CDSCO File M/s Bayer (1) Primary objective of the study 5. No: Pharmaceuticals Pvt. BIO/CT/20/000094) Ltd. should be safety and secondary Aflibercept objective should be efficacy. (2) The study shall be an interventional study.

Accordingly, the firm should submit the revised protocol to CDSCO.

Dr. Somesh Aggrawal did not participate in the deliberation.

Firm presented their proposal along with the protocol for conduct of BIO/CT04/FF/2020/ Phase IV clinical trial before the 20653 (CDSCO File committee. M/s Reliance Life No.: 6. Sciences Pvt. Ltd. After detailed deliberation, the BIO/CT/20/000126) committee recommended for grant Ranibizumab of permission to conduct the Phase IV study as per the protocol presented.

04-31/Sandoz/PAC- Firm presented their proposal for inclusion of “Consulting Physician R-Erenumab/2020- M/s Sandoz Private and Ophthalmologist” as 7. BD Limited prescribers for Erenumab. Erenumab After detailed deliberation, the

SEC (Ophthalmology) 29.09.2020 committee recommended that the proposal may be deliberated in the SEC (Neurology and Psychiatry)

SND Division In light of earlier recommendation SND/CT/20/000024 of SEC meeting dated 15.07.2020, the firm presented the revised M/s Shilpa medicare Phase III Clinical Trial protocol. Ophthalmic Solution 8. Ltd After detailed deliberation the 0.75% committee recommended for grant (Additional strength) of permission for conduct of Phase III Clinical Trial as per the protocol presented. In light of earlier recommendation of SEC meeting dated 22.06.2020 the firm presented the clarification on the composition of the ionic buffer preservative system used in the Eye Drops 0.04% w/v and stated that it was a 12-136/2016-DC (Pt- typographical error in the PPT Akums-SND) presented during earlier SEC M/s Akums Drugs & meeting. Travoprost Eye 9. The committee was also informed Drops 0.04% w/v Pharmaceuticals Ltd that as per submitted dossier on Preserved with ionic CMC, the composition of buffer buffer system was in-line with innovator’s ionic buffer system composition. After detailed deliberation, the committee recommended for grant of permission to manufacture and market Travoprost Eye Drops 0.04% w/v preserved with ionic buffer system. The firm presented their proposal along with the published literature SND/MA/20/000199 of various Clinical Trials for the proposed product. Sulfate M/s Sun Pharma It was noted that the proposed 10. Ophthalmic Solution Laboratories Ltd product is already approved in 0.01% w/v Japan, Singapore, Malaysia and Taiwan. After detailed deliberation the committee recommended for grant SEC (Ophthalmology) 29.09.2020 of permission to manufacture and market Atropine Sulfate Ophthalmic Solution 0.01% w/v subject to condition that firm should conduct Phase IV Clinical Trial to assess long term safety of the product. Accordingly, the firm should submit Phase IV Clinical Trial protocol within 3 months of approval of the product. GCT Division CT/24/20 M/s Novartis The firm presented their response to Clinical Trial NOC conditions. Online Submission After detailed deliberation the committee recommended for Brolucizumab conduct of the study subject to condition that during screening of 11. trial participants, every site should carry out PCR testing to rule out COVID-19 infection and also at every visits the investigator shall follow the prevailing COVID-19 guidelines. CT/87/20 M/s. Cliantha Firm presented their Phase III clinical trial proposal before the Online Submission committee. MYL-170IP Assessment of Risk versus benefit to the patients- The safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial.

Innovation vis-a-vis existing therapeutic- Evaluate the Safety 12. and Efficacy of MYL-1701P in Subjects with Diabetic Macular Edema Completed MYL-1701P- 3001 Study.

Unmet medical need in the country- The test drug used for Diabetic Macular Edema.

After detailed deliberation the committee recommended for grant of permission to conduct the study.

SEC (Ophthalmology) 29.09.2020 Dr. Somesh Aggarwal didn’t participate in presentation.

Medical Device Division IMP/MD/2020/2616 M/s Caregroup Sight Firm presented their proposal 5 Solution private before the committee. Trabecular Micro- limited The committee noted that device is Bypass System approved for marketing in USA,

Canada, EU etc. After detailed deliberation, the committee recommended for grant 13. of permission to import & market the product subject to the condition that the firm should conduct Phase IV clinical investigation in India. Accordingly, the firm should submit Phase IV protocol within 3 months from the approval for further review by the committee.

SEC (Ophthalmology) 29.09.2020